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The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the
Department of Health and Human Services The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is " ...
. The FDA is responsible for protecting and promoting
public health Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals". Analyzing the det ...
through the control and supervision of
food safety Food safety (or food hygiene) is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent food-borne illness. The occurrence of two or more cases of a similar illness resulting from t ...
,
tobacco Tobacco is the common name of several plants in the genus '' Nicotiana'' of the family Solanaceae, and the general term for any product prepared from the cured leaves of these plants. More than 70 species of tobacco are known, but the ...
products,
caffeine Caffeine is a central nervous system (CNS) stimulant of the methylxanthine class. It is mainly used recreationally as a cognitive enhancer, increasing alertness and attentional performance. Caffeine acts by blocking binding of adenosine t ...
products,
dietary supplement A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill, capsule, tablet, powder, or liquid. A supplement can provide nutrients either extracted from food sources or that are synthetic in order ...
s, prescription and
over-the-counter Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescr ...
pharmaceutical drug A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and re ...
s (medications),
vaccine A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifie ...
s,
biopharmaceutical A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, t ...
s,
blood transfusion Blood transfusion is the process of transferring blood products into a person's circulation intravenously. Transfusions are used for various medical conditions to replace lost components of the blood. Early transfusions used whole blood, but mo ...
s,
medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
s,
electromagnetic radiation In physics, electromagnetic radiation (EMR) consists of waves of the electromagnetic field, electromagnetic (EM) field, which propagate through space and carry momentum and electromagnetic radiant energy. It includes radio waves, microwaves, inf ...
emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the
Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...
(FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating
lasers A laser is a device that emits light through a process of optical amplification based on the stimulated emission of electromagnetic radiation. The word "laser" is an acronym for "light amplification by stimulated emission of radiation". The fir ...
,
cellular phones A mobile phone, cellular phone, cell phone, cellphone, handphone, hand phone or pocket phone, sometimes shortened to simply mobile, cell, or just phone, is a portable telephone that can make and receive calls over a radio frequency link whil ...
, and
condoms A condom is a sheath-shaped barrier device used during sexual intercourse to reduce the probability of pregnancy or a sexually transmitted infection (STI). There are both male and female condoms. With proper use—and use at every act of inte ...
, as well as control of disease in contexts varying from household pets to human sperm donated for use in
assisted reproduction Assisted reproductive technology (ART) includes medical procedures used primarily to address infertility. This subject involves procedures such as in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), cryopreservation of gametes ...
. The FDA is led by the
Commissioner of Food and Drugs The United States Commissioner of Food and Drugs is the head of the Food and Drug Administration (FDA), an agency of the United States Department of Health and Human Services. The commissioner is appointed by the president of the United States an ...
, appointed by the President with the
advice and consent Advice and consent is an English phrase frequently used in enacting formulae of bills and in other legal or constitutional contexts. It describes either of two situations: where a weak executive branch of a government enacts something previo ...
of the
Senate A senate is a deliberative assembly, often the upper house or chamber of a bicameral legislature. The name comes from the ancient Roman Senate (Latin: ''Senatus''), so-called as an assembly of the senior (Latin: ''senex'' meaning "the el ...
. The Commissioner reports to the
Secretary of Health and Human Services The United States secretary of health and human services is the head of the United States Department of Health and Human Services, and serves as the principal advisor to the president of the United States on all health matters. The secretary is ...
.
Robert Califf Robert McKinnon Califf (born 1951) is an American cardiologist who currently serves as the 25th Commissioner of the Food and Drug Administration. He was first nominated to be commissioner in September 2015 by President Barack Obama and he wa ...
is the current commissioner, . The FDA has its headquarters in
unincorporated Unincorporated may refer to: * Unincorporated area, land not governed by a local municipality * Unincorporated entity, a type of organization * Unincorporated territories of the United States, territories under U.S. jurisdiction, to which Congress ...
White Oak, Maryland White Oak is a census-designated place and an unincorporated area in Montgomery County, Maryland, United States. It had a population of 16,347 in 2020. White Oak was known for its Naval Ordnance Laboratory, which was closed in 1994. The headquar ...
. The agency also has 223 field offices and 13
laboratories A laboratory (; ; colloquially lab) is a facility that provides controlled conditions in which scientific or technological research, experiments, and measurement may be performed. Laboratory services are provided in a variety of settings: physicia ...
located throughout the 50 states, the
United States Virgin Islands The United States Virgin Islands,. Also called the ''American Virgin Islands'' and the ''U.S. Virgin Islands''. officially the Virgin Islands of the United States, are a group of Caribbean islands and an unincorporated and organized territory ...
, and
Puerto Rico Puerto Rico (; abbreviated PR; tnq, Boriken, ''Borinquen''), officially the Commonwealth of Puerto Rico ( es, link=yes, Estado Libre Asociado de Puerto Rico, lit=Free Associated State of Puerto Rico), is a Caribbean island and Unincorporated ...
. In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.


Organizational structure

*
Department of Health and Human Services The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is " ...
** Food and Drug Administration *** Office of the Commissioner *** Office of Operations **** Office of Equal Employment Opportunity **** Office of Human Resources **** Office of Finance, Budget and Acquisition **** Office of Information Management and Technology ***** Office of Informatics & Technology Innovation ****** ***** Office of Information Management **** Office of Security Operations **** Office of Facilities Engineering and Mission Support Services ***
Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Dir ...
(CBER) ***
Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safe ...
(CDRH) ***
Center for Drug Evaluation and Research The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also leg ...
(CDER) ***
Center for Food Safety and Applied Nutrition The Center for Food Safety and Applied Nutrition (CFSAN ( )) is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, cosmetics, drugs, biologics, medical devices, and radiological products. ...
(CFSAN) ***
Center for Tobacco Products The Center for Tobacco Products (CTP) was established by the United States Food and Drug Administration as a result of the Family Smoking Prevention and Tobacco Control Act signed by President Obama Barack Hussein Obama II ( ; born August ...
(CTP) ***
Center for Veterinary Medicine The Center for Veterinary Medicine (CVM) is a branch of the U.S. Food and Drug Administration (FDA) that regulates the manufacture and distribution of food, food additives, and drugs that will be given to animals. These include animals from which ...
(CVM) *** Oncology Center of Excellence (OCE) ***
Office of Regulatory Affairs The Office of Global Regulatory Operations and Policy (GO), also known as the Office of Regulatory Affairs (ORA), is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplem ...
*** Office of Clinical Policy and Programs *** Office of External Affairs *** Office of Food Policy and Response *** Office of Minority Health and Health Equity *** Office of Policy, Legislation, and International Affairs *** Office of the Chief Scientist *** Office of Women's Health ***
National Center for Toxicological Research The National Center for Toxicological Research (NCTR) is a branch of the U.S. Food & Drug Administration (FDA) located in Jefferson, Arkansas. Established in 1971, the Center conducts scientific research to provide reliable data for Food & Dr ...
(NCTR)


Location


Headquarters

FDA headquarters facilities are currently located in Montgomery County and
Prince George's County ) , demonym = Prince Georgian , ZIP codes = 20607–20774 , area codes = 240, 301 , founded date = April 23 , founded year = 1696 , named for = Prince George of Denmark , leader_title = Executive , leader_name = Angela D. Alsobrook ...
, Maryland.


White Oak Federal Research Center

Since 1990, the FDA has had employees and facilities on of the White Oak Federal Research Center in the
White Oak The genus ''Quercus'' contains about 500 species, some of which are listed here. The genus, as is the case with many large genera, is divided into subgenera and sections. Traditionally, the genus ''Quercus'' was divided into the two subgenera '' ...
area of
Silver Spring, Maryland Silver Spring is a census-designated place (CDP) in southeastern Montgomery County, Maryland, United States, near Washington, D.C. Although officially unincorporated, in practice it is an edge city, with a population of 81,015 at the 2020 censu ...
.Coordinates of FDA Headquarters at White Oak, Maryland: In 2001, the
General Services Administration The General Services Administration (GSA) is an independent agency of the United States government established in 1949 to help manage and support the basic functioning of federal agencies. GSA supplies products and communications for U.S. gover ...
(GSA) began new construction on the campus to consolidate the FDA's 25 existing operations in the
Washington metropolitan area The Washington metropolitan area, also commonly referred to as the National Capital Region, is the metropolitan area centered on Washington, D.C. The metropolitan area includes all of Washington, D.C. and parts of the states of Maryland, Virgin ...
, its headquarters in Rockville, and several fragmented office buildings. The first building, the Life Sciences Laboratory, was dedicated and opened with 104 employees in December 2003. As of December 2018, the FDA campus has a population of 10,987 employees housed in approximately of space, divided into ten office and four laboratory buildings. The campus houses the Office of the Commissioner (OC), the Office of Regulatory Affairs (ORA),  the
Center for Drug Evaluation and Research The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also leg ...
(CDER), the
Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safe ...
(CDRH), the
Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Dir ...
(CBER) and offices for the
Center for Veterinary Medicine The Center for Veterinary Medicine (CVM) is a branch of the U.S. Food and Drug Administration (FDA) that regulates the manufacture and distribution of food, food additives, and drugs that will be given to animals. These include animals from which ...
(CVM). With the passing of the
FDA Reauthorization Act of 2017 The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
, the FDA is projecting a 64% increase in employees to 18,000 over the next 15 years, and would like to add approximately of office and special use space to their existing facilities. The
National Capital Planning Commission The National Capital Planning Commission (NCPC) is a U.S. government executive branch agency that provides planning guidance for Washington, D.C., and the surrounding National Capital Region. Through its planning policies and review of developmen ...
approved a new master plan for this expansion in December 2018, and construction is expected to be completed by 2035, dependent on GSA appropriations.


Field locations


Office of Regulatory Affairs

The
Office of Regulatory Affairs The Office of Global Regulatory Operations and Policy (GO), also known as the Office of Regulatory Affairs (ORA), is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplem ...
is considered the agency's "eyes and ears," conducting the vast majority of the FDA's work in the field. Its employees, known as Consumer Safety Officers, or more commonly known simply as investigators, inspect production and warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in the case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. The Office of Regulatory Affairs is divided into five regions, which are further divided into 20 districts. Districts are based roughly on the geographic divisions of the Federal court system. Each district comprises a main district office and a number of Resident Posts, which are FDA remote offices that serve a particular geographic area. ORA also includes the Agency's network of regulatory laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices.


Office of Criminal Investigations

The
Office of Criminal Investigations The United States Food and Drug Administration (FDA) Office of Criminal Investigations (OCI) provides the FDA with a specific office to conduct and coordinate its criminal investigations. OCI special agents employ federal law enforcement methods ...
was established in 1991 to investigate criminal cases. To do so, OCI employs approximately 200 Special Agents nationwide who, unlike ORA Investigators, are armed, have badges, and do not focus on technical aspects of the regulated industries. Rather, OCI agents pursue and develop cases when individuals and companies commit criminal actions, such as fraudulent claims or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI pursues cases involving violations of
Title 18 of the United States Code Title 18 of the United States Code is the main criminal code of the federal government of the United States. The Title deals with federal crimes and criminal procedure. In its coverage, Title 18 is similar to most U.S. state criminal codes, w ...
(e.g., conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of the FD&C Act. OCI Special Agents often come from other criminal investigations backgrounds, and frequently work closely with the
Federal Bureau of Investigation The Federal Bureau of Investigation (FBI) is the domestic intelligence and security service of the United States and its principal federal law enforcement agency. Operating under the jurisdiction of the United States Department of Justice, ...
,
Assistant Attorney General Many of the divisions and offices of the United States Department of Justice are headed by an assistant attorney general. The president of the United States appoints individuals to the position of assistant attorney general with the advice and ...
, and even
Interpol The International Criminal Police Organization (ICPO; french: link=no, Organisation internationale de police criminelle), commonly known as Interpol ( , ), is an international organization that facilitates worldwide police cooperation and cri ...
. OCI receives cases from a variety of sources—including ORA, local agencies, and the FBI, and works with ORA Investigators to help develop the technical and science-based aspects of a case.


Other locations

The FDA has a number of field offices across the United States, in addition to international locations in China, India, Europe, the Middle East, and Latin America.


Scope and funding

As of 2021, the FDA had responsibility for overseeing $2.7 trillion in food, medical, and tobacco products. Some 54% of its budget derives from the federal government, and 46% is covered by industry user fees for FDA services. For example, pharmaceutical firms pay fees to expedite drug reviews.


Regulatory programs


Emergency approvals (EUA)

Emergency Use Authorization (EUA) is a mechanism that was created to facilitate the availability and use of medical countermeasures, including vaccines and personal protective equipment, during public health emergencies such as the Zika virus epidemic, the Ebola virus epidemic and the COVID-19 pandemic.


Regulations

The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety—yet FDA regulation of cosmetics focuses primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on Form 483. In June 2018, the FDA released a statement regarding new guidelines to help food and drug manufacturers "implement protections against potential attacks on the U.S. food supply". One of the new guidelines includes the Intentional Adulteration (IA) rule, which requires strategies and procedures by the food industry to reduce the risk of compromise in facilities and processes that are significantly vulnerable. The FDA also uses tactics of regulatory shaming, mainly through online publication of non-compliance, warning letters, and "shaming lists." Regulation by shaming harnesses firms' sensitivity to reputational damage. For example, in 2018, the agency published an online "black list," in which it named dozens of branded drug companies that are supposedly using unlawful or unethical means to attempt to impede competition from
generic drug A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active ch ...
companies. The FDA frequently works with other federal agencies, including the Department of Agriculture, the
Drug Enforcement Administration The Drug Enforcement Administration (DEA; ) is a Federal law enforcement in the United States, United States federal law enforcement agency under the U.S. Department of Justice tasked with combating drug trafficking and distribution within th ...
, Customs and Border Protection, and the
Consumer Product Safety Commission The United States Consumer Product Safety Commission (USCPSC, CPSC, or commission) is an independent agency of the United States government. The CPSC seeks to promote the safety of consumer products by addressing “unreasonable risks” of inj ...
. They also often work with local and state government agencies in performing regulatory inspections and enforcement actions.


Food and dietary supplements

The regulation of food and dietary supplements by the Food and Drug Administration is governed by various statutes enacted by the
United States Congress The United States Congress is the legislature of the federal government of the United States. It is bicameral, composed of a lower body, the House of Representatives, and an upper body, the Senate. It meets in the U.S. Capitol in Washing ...
and interpreted by the FDA. Pursuant to the
Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...
and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the
labeling Labelling or using a label is describing someone or something in a word or short phrase. For example, the label "criminal" may be used to describe someone who has broken a law. Labelling theory is a theory in sociology which ascribes labelling ...
of both the composition and the health benefits of foods. The FDA subdivides substances that it regulates as food into various categories—including foods,
food additive Food additives are substances added to food to preserve flavor or enhance taste, appearance, or other sensory qualities. Some additives have been used for centuries as part of an effort to preserve food, for example vinegar (pickling), salt (salt ...
s, added substances (man-made substances that are not intentionally introduced into food, but nevertheless end up in it), and
dietary supplements A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill (pharmacy), pill, capsule (pharmacy), capsule, tablet (pharmacy), tablet, powder, or liquid. A supplement can provide nutrients either extr ...
. Dietary supplements or dietary ingredients include vitamins, minerals, herbs, amino acids, and. enzymes. Specific standards the FDA exercises differ from one category to the next. Furthermore, legislation had granted the FDA a variety of means to address violations of standards for a given substance category. Under the
Dietary Supplement Health and Education Act of 1994 The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are regulated by the FDA for Good Manufacturing P ...
(DSHEA), the FDA is responsible for ensuring that manufacturers and distributors of dietary supplements and dietary ingredients meet the current requirements. These manufacturers and distributors are not allowed to advertise their products in an adulterated way, and they are responsible for evaluating the safety and labeling of their product. The FDA has a "Dietary Supplement Ingredient Advisory List" that includes ingredients that sometimes appear on dietary supplements but need further evaluation further. An ingredient is added to this list when it is excluded from use in a dietary supplement, does not appear to be an approved food additive or recognized as safe, and/or is subjected to the requirement for pre-market notification without having a satisfied requirement.


"FDA-Approved" vs. "FDA-Accepted in Food Processing"

The FDA does not approve applied coatings used in the
food processing industry Food processing is the transformation of agricultural products into food, or of one form of food into other forms. Food processing includes many forms of processing foods, from grinding grain to make raw flour to home cooking to complex indu ...
. There is no review process to approve the composition of nonstick coatings; nor does the FDA inspect or test these materials. Through their governing of processes, however, the FDA does have a set of regulations that cover the formulation, manufacturing, and use of nonstick coatings. Hence, materials like
Polytetrafluoroethylene Polytetrafluoroethylene (PTFE) is a synthetic fluoropolymer of tetrafluoroethylene that has numerous applications. It is one of the best-known and widely applied PFAS. The commonly known brand name of PTFE-based composition is Teflon by Chemour ...
(Teflon) are not, and cannot be, considered as FDA Approved, rather, they are "FDA Compliant" or "FDA Acceptable".


Medical countermeasures (MCMs)

Medical countermeasures (MCMs) are products such as
biologics A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, th ...
and
pharmaceutical drug A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and re ...
s that can protect from or treat the health effects of a chemical, biological, radiological, or nuclear (CBRN) attack. MCMs can also be used for prevention and diagnosis of symptoms associated with CBRN attacks or threats. The FDA runs a program called the "FDA Medical Countermeasures Initiative" (MCMi), with programs funded by the federal government. It helps support "partner" agencies and organisations prepare for
public health emergencies In public relations and communication science, publics are groups of individual people, and the public (a.k.a. the general public) is the totality of such groupings. This is a different concept to the sociological concept of the ''Öffentlichkei ...
that could require MCMs.


Medications

The
Center for Drug Evaluation and Research The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also leg ...
uses different requirements for the three main drug product types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different
excipient An excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts (thus often referred ...
s or inactive ingredients, is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to ''new molecular entities'': drugs that are not based on existing medications.


New medications

New drugs receive extensive scrutiny before FDA approval in a process called a new drug application (NDA). Under the Trump administration, the agency has worked to make the drug-approval process go faster. Critics, however, argue that the FDA standards are not sufficiently rigorous, allowing unsafe or ineffective drugs to be approved. New drugs are available only by prescription by default. A change to over-the-counter (OTC) status is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed". Very rare, limited exceptions to this multi-step process involving animal testing and controlled clinical trials can be granted out of compassionate use protocols. This was the case during the 2015 Ebola epidemic with the use, by prescription and authorization, of
ZMapp ZMapp is an experimental biopharmaceutical drug comprising three chimeric monoclonal antibodies under development as a treatment for Ebola virus disease. Two of the three components were originally developed at the Public Health Agency of Canada ...
and other experimental treatments, and for new drugs that can be used to treat debilitating and/or very rare conditions for which no existing remedies or drugs are satisfactory, or where there has not been an advance in a long period of time. The studies are progressively longer, gradually adding more individuals as they progress from stage I to stage III, normally over a period of years, and normally involve drug companies, the government and its laboratories, and often medical schools and hospitals and clinics. However, any exceptions to the aforementioned process are subject to strict review and scrutiny and conditions, and are only given if a substantial amount of research and at least some preliminary human testing has shown that they are believed to be somewhat safe and possibly effective. (See FDA Special Protocol Assessment about Phase III trials.)


=Advertising and promotion

= The FDA's Office of Prescription Drug Promotion reviews and regulates prescription drug advertising and promotion through surveillance activities and issuance of enforcement letters to pharmaceutical manufacturers. Advertising and promotion for over-the-counter drugs is regulated by the
Federal Trade Commission The Federal Trade Commission (FTC) is an independent agency of the United States government whose principal mission is the enforcement of civil (non-criminal) antitrust law and the promotion of consumer protection. The FTC shares jurisdiction ov ...
. The FDA also empowers third-party enforcer-firms to engage in some regulatory oversight, e.g. the FDA expects pharmaceutical companies to make sure that third-party suppliers and labs abide by the agency's health and safety guidelines. The drug advertising regulation contains two broad requirements: (1) a company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug. The term
off-label Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although m ...
refers to drug usage for indications other than those approved by the FDA.


=Post-market safety surveillance

= After NDA approval, the sponsor must then review and report to the FDA every single patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis. The FDA also receives directly adverse drug event reports through its MedWatch program. These reports are called "spontaneous reports" because reporting by consumers and health professionals is voluntary. While this remains the primary tool of post-market safety surveillance, FDA requirements for post-marketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional
clinical trials Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
, called Phase IV trials. In some cases, the FDA requires risk management plans called
Risk Evaluation and Mitigation Strategies Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply ...
(REMS) for some drugs that require actions to be taken to ensure that the drug is used safely. For example,
thalidomide Thalidomide, sold under the brand names Contergan and Thalomid among others, is a medication used to treat a number of cancers (including multiple myeloma), graft-versus-host disease, and a number of skin conditions including complications of ...
can cause birth defects, but has uses that outweigh the risks if men and women taking the drugs do not conceive a child; a REMS program for thalidomide mandates an auditable process to ensure that people taking the drug take action to avoid pregnancy; many
opioid Opioids are substances that act on opioid receptors to produce morphine-like effects. Medically they are primarily used for pain relief, including anesthesia. Other medical uses include suppression of diarrhea, replacement therapy for opioid us ...
drugs have REMS programs to avoid addiction and diversion of drugs. The drug
isotretinoin Isotretinoin, also known as 13-''cis''-retinoic acid and sold under the brand name Accutane among others, is a medication primarily used to treat severe acne. It is also used to prevent certain skin cancers (squamous-cell carcinoma), and in th ...
has a REMS program called
iPLEDGE The iPLEDGE program is a program by the Food and Drug Administration (United States), U.S. Food and Drug Administration (FDA) for managing the risk of isotretinoin (also known as Accutane), a prescription medication used for the treatment of acn ...
.


Generic drugs

Generic drugs are chemical and therapeutic equivalents of
name-brand A brand is a name, term, design, symbol or any other feature that distinguishes one seller's good or service from those of other sellers. Brands are used in business, marketing, and advertising for recognition and, importantly, to create an ...
drugs, normally whose patents have expired. Approved generic drugs should have the same dosage, safety, effectiveness, strength, stability, and quality, as well as route of administration. In general, they are less expensive than their name brand counterparts, are manufactured and marketed by rival companies and, in the 1990s, accounted for about a third of all prescriptions written in the United States. For a pharmaceutical company to gain approval to produce a generic drug, the FDA requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug. This is called an
Abbreviated New Drug Application An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to Food and Drug Administration, FDA's Center for Drug Evaluation and Resea ...
(ANDA). As of 2012, 80% of all FDA approved drugs are available in generic form.


=Generic drug scandal

= In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public. Charges of corruption in generic drug approval first emerged in 1988 during the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the United States House Energy and Commerce Committee resulted from a complaint brought against the FDA by
Mylan Laboratories Inc. Mylan N.V. was a global generic and specialty pharmaceuticals company. In November 2020, Mylan merged with Upjohn, Pfizer's off-patent medicine division, to form Viatris. Previously, the company was domiciled in the Netherlands, with principal e ...
of
Pittsburgh Pittsburgh ( ) is a city in the Commonwealth (U.S. state), Commonwealth of Pennsylvania, United States, and the county seat of Allegheny County, Pennsylvania, Allegheny County. It is the most populous city in both Allegheny County and Wester ...
. When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within the federal agency resulted in
racketeering Racketeering is a type of organized crime in which the perpetrators set up a coercive, fraudulent, extortionary, or otherwise illegal coordinated scheme or operation (a "racket") to repeatedly or consistently collect a profit. Originally and of ...
and in violations of
antitrust law Competition law is the field of law that promotes or seeks to maintain market competition by regulating anti-competitive conduct by companies. Competition law is implemented through public and private enforcement. It is also known as antitrust ...
. "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies (
Par Pharmaceutical Endo International plc is an American Irish-domiciled generics and specialty branded pharmaceutical company that generated over 93% of its 2017 sales from the U.S. healthcare system. While Endo's management, operations, and customers are almost ...
and its subsidiary Quad Pharmaceuticals) pleaded guilty to giving bribes. Furthermore, it was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug
Dyazide Hydrochlorothiazide/triamterene, also known as co-triamterzide, is a fixed-dose combination medication of hydrochlorothiazide and triamterene. It is used to treat high blood pressure and edema (swelling). Specifically it is used in those who dev ...
, a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers. In the early 1990s, the
U.S. Securities and Exchange Commission The U.S. Securities and Exchange Commission (SEC) is an independent agency of the United States federal government, created in the aftermath of the Wall Street Crash of 1929. The primary purpose of the SEC is to enforce the law against market ...
filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York.


Over-the-counter drugs

Over-the-counter (OTC) are drugs like
aspirin Aspirin, also known as acetylsalicylic acid (ASA), is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce pain, fever, and/or inflammation, and as an antithrombotic. Specific inflammatory conditions which aspirin is used to treat inc ...
that do not require a doctor's prescription. The FDA has a list of approximately 800 such approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without a
medical practitioner A physician (American English), medical practitioner (Commonwealth English), medical doctor, or simply doctor, is a health professional who practices medicine, which is concerned with promoting, maintaining or restoring health through th ...
's supervision like
ibuprofen Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used for treating pain, fever, and inflammation. This includes painful menstrual periods, migraines, and rheumatoid arthritis. It may also be used to close a patent ductus arte ...
.


Ebola treatment

In 2014, the FDA added an
Ebola Ebola, also known as Ebola virus disease (EVD) and Ebola hemorrhagic fever (EHF), is a viral hemorrhagic fever in humans and other primates, caused by ebolaviruses. Symptoms typically start anywhere between two days and three weeks after becom ...
treatment being developed by Canadian pharmaceutical company Tekmira to the Fast Track program, but halted the phase 1 trials in July pending the receipt of more information about how the drug works. This was widely viewed as increasingly important in the face of a major outbreak of the disease in West Africa that began in late March 2014 and ended in June 2016.


Coronavirus (COVID-19) testing

During the
coronavirus pandemic The COVID-19 pandemic, also known as the coronavirus pandemic, is an ongoing global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The novel virus was first identified ...
, FDA granted
emergency use authorization An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Act of Congress, Acts of ...
for
personal protective equipment Personal protective equipment (PPE) is protective clothing, helmets, goggles, or other garments or equipment designed to protect the wearer's body from injury or infection. The hazards addressed by protective equipment include physical, elec ...
(PPE), in vitro diagnostic equipment,
ventilator A ventilator is a piece of medical technology that provides mechanical ventilation by moving breathable air into and out of the lungs, to deliver breaths to a patient who is physically unable to breathe, or breathing insufficiently. Ventilators ...
s and other medical devices. On March 18, 2020, FDA inspectors postponed most foreign facility inspections and all domestic routine surveillance facility inspections. In contrast, the USDA's
Food Safety and Inspection Service The Food Safety and Inspection Service (FSIS), an agency of the United States Department of Agriculture (USDA), is the public health regulatory agency responsible for ensuring that United States' commercial supply of meat, poultry, and egg pro ...
(FSIS) continued inspections of meatpacking plants, which resulted in 145 FSIS field employees who tested positive for COVID-19, and three who died.


Vaccines, blood and tissue products, and biotechnology

The
Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Dir ...
is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents. These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a premarket approval process called a
Biologics License Application A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into inters ...
(BLA), similar to that for drugs. The original authority for government regulation of biological products was established by the 1902
Biologics Control Act The Biologics Control Act of 1902, also known as the Virus-Toxin Law, was the first law that implemented federal regulations of biological products such as vaccines in the United States. It was enacted in response to two incidents involving the d ...
, with additional authority established by the 1944
Public Health Service Act The Public Health Service Act is a United States federal law enacted in 1944. The full act is codified in Title 42 of the United States Code (The Public Health and Welfare), Chapter 6A (Public Health Service). Contents The act clearly establis ...
. Along with these Acts, the
Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...
applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the
National Institutes of Health The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
; this authority was transferred to the FDA in 1972.


Medical and radiation-emitting devices

The
Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safe ...
(CDRH) is the branch of the FDA responsible for the premarket approval of all
medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
s, as well as overseeing the manufacturing, performance and safety of these devices. The definition of a medical device is given in the FD&C Act, and it includes products from the simple
toothbrush A toothbrush is an oral hygiene tool used to clean the teeth, gums, and tongue. It consists of a head of tightly clustered bristles, atop of which toothpaste can be applied, mounted on a handle which facilitates the cleaning of hard-to-reach are ...
to complex devices such as implantable
neurostimulator Neurostimulation is the purposeful modulation of the nervous system's activity using invasive (e.g. microelectrodes) or non-invasive means (e.g. transcranial magnetic stimulation or transcranial electric stimulation, tES, such as tDCS or transcr ...
s. CDRH also oversees the safety performance of non-medical devices that emit certain types of
electromagnetic radiation In physics, electromagnetic radiation (EMR) consists of waves of the electromagnetic field, electromagnetic (EM) field, which propagate through space and carry momentum and electromagnetic radiant energy. It includes radio waves, microwaves, inf ...
. Examples of CDRH-regulated devices include
cellular phones A mobile phone, cellular phone, cell phone, cellphone, handphone, hand phone or pocket phone, sometimes shortened to simply mobile, cell, or just phone, is a portable telephone that can make and receive calls over a radio frequency link whil ...
, airport baggage screening equipment, television receivers,
microwave oven A microwave oven (commonly referred to as a microwave) is an electric oven that heats and cooks food by exposing it to electromagnetic radiation in the microwave frequency range. This induces polar molecules in the food to rotate and produce t ...
s,
tanning booth Indoor tanning involves using a device that emits ultraviolet radiation to produce a cosmetic tan. Typically found in tanning salons, gyms, spas, hotels, and sporting facilities, and less often in private residences, the most common device is a ho ...
s, and laser products. CDRH regulatory powers include the authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. CDRH also conducts limited amounts of direct product testing.


"FDA-Cleared" vs "FDA-Approved"

Clearance requests are required for medical devices that prove they are "substantially equivalent" to the predicate devices already on the market. Approved requests are for items that are new or substantially different and need to demonstrate "safety and efficacy", for example they may be inspected for safety in case of new toxic hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed.


Cosmetics

Cosmetics are regulated by the
Center for Food Safety and Applied Nutrition The Center for Food Safety and Applied Nutrition (CFSAN ( )) is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, cosmetics, drugs, biologics, medical devices, and radiological products. ...
, the same branch of the FDA that regulates food. Cosmetic products are not, in general, subject to premarket approval by the FDA unless they make "structure or function claims" that make them into drugs (see
Cosmeceutical Cosmeceuticals are cosmetic products with bioactive ingredients purported to have medical benefits. In America, there are no legal requirements to prove that these products live up to their claims. The name is a portmanteau of "cosmetics" and " ...
). However, all color additives must be specifically FDA approved before manufacturers can include them in cosmetic products sold in the U.S. The FDA regulates cosmetics labeling, and cosmetics that have not been safety tested must bear a warning to that effect. According to the industry advocacy group the
American Council on Science and Health The American Council on Science and Health (ACSH) is a pro-industry advocacy organization founded in 1978 by Elizabeth Whelan. ACSH's publications focus on advocacy related to food, nutrition, health, chemicals, pharmaceuticals, biology, biot ...
, though the cosmetic industry is predominantly responsible in ensuring the safety of its products, the FDA also has the power to intervene when necessary to protect the public but in general does not require pre-market approval or testing. The ACSH says that companies are required to place a warning note on their products if they have not been tested and that experts in cosmetic ingredient reviews also play a role in monitoring safety through influence on the use of ingredients, but also lack legal authority. According to the ACSH, overall the organization has reviewed about 1,200 ingredients and has suggested that several hundred be restricted, but there is no standard or systemic method for reviewing chemicals for safety and a clear definition of what is meant by 'safety' so that all chemicals are tested on the same basis.


Veterinary products

The
Center for Veterinary Medicine The Center for Veterinary Medicine (CVM) is a branch of the U.S. Food and Drug Administration (FDA) that regulates the manufacture and distribution of food, food additives, and drugs that will be given to animals. These include animals from which ...
(CVM) is a center of the FDA that regulates food additives and drugs that are given to animals. CVM regulates animal drugs, animal food including pet animal, and animal medical devices. The FDA's requirements to prevent the spread of
bovine spongiform encephalopathy Bovine spongiform encephalopathy (BSE), commonly known as mad cow disease, is an incurable and invariably fatal neurodegenerative disease of cattle. Symptoms include abnormal behavior, trouble walking, and weight loss. Later in the course of t ...
are also administered by CVM through inspections of feed manufacturers. CVM does not regulate vaccines for animals; these are handled by the
United States Department of Agriculture The United States Department of Agriculture (USDA) is the United States federal executive departments, federal executive department responsible for developing and executing federal laws related to farming, forestry, rural economic development, ...
.


Tobacco products

The FDA regulates
tobacco products Tobacco is the agricultural product of the leaves of plants in the genus ''Nicotiana'', commonly termed ''tobacco plants''. All species of ''Nicotiana'' contain the addictive drug nicotine—a psychostimulant alkaloid found in all parts of the ...
with authority established by the 2009
Family Smoking Prevention and Tobacco Control Act Family (from la, familia) is a group of people related either by consanguinity (by recognized birth) or affinity (by marriage or other relationship). The purpose of the family is to maintain the well-being of its members and of society. Ideall ...
. This Act requires color warnings on cigarette packages and printed advertising, and text warnings from the
U.S. Surgeon General The surgeon general of the United States is the operational head of the United States Public Health Service Commissioned Corps (PHSCC) and thus the leading spokesperson on matters of public health in the federal government of the United States. Th ...
. The nine new graphic warning labels were announced by the FDA in June 2011 and were scheduled to be required to appear on packaging by September 2012. The implementation date is uncertain, due to ongoing proceedings in the case of R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration.
R.J. Reynolds Richard Joshua Reynolds (July 20, 1850 – July 29, 1918) was an American businessman and founder of the R. J. Reynolds Tobacco Company. The son of a tobacco farmer, he worked for his father and attended Emory & Henry College from 1868 to 1870, ...
,
Lorillard Lorillard Tobacco Company was an American tobacco company that marketed cigarettes under the brand names Newport (cigarette), Newport, Maverick (cigarette), Maverick, Old Gold (cigarette), Old Gold, Kent (cigarette), Kent, True (cigarette), True, ...
,
Commonwealth Brands ITG Brands, LLC is the third-largest American tobacco manufacturing company in the United States. It is a subsidiary of British multinational Imperial Brands. ITG Brands markets and sells multiple cigarette and cigar brands and sells blu eCigs ...
,
Liggett Group Liggett Group ( ), formerly known as Liggett & Myers Tobacco Company, is the fourth largest tobacco company in the United States. Its headquarters are located in Durham, North Carolina, though its manufacturing facility is 30 miles to the west in ...
and
Santa Fe Natural Tobacco Company Santa Fe Natural Tobacco Company (sometimes abbreviated SFNTC) is an American tobacco manufacturing company based in Oxford, NC, best known for its production of the premier ''Natural American Spirit'' cigarette brand. Founded in 1982, SFNTC bec ...
have filed suit in Washington, D.C. federal court claiming that the graphic labels are an
unconstitutional Constitutionality is said to be the condition of acting in accordance with an applicable constitution; "Webster On Line" the status of a law, a procedure, or an act's accordance with the laws or set forth in the applicable constitution. When l ...
way of forcing tobacco companies to engage in anti-smoking advocacy on the government's behalf. A
First Amendment First or 1st is the ordinal form of the number one (#1). First or 1st may also refer to: *World record, specifically the first instance of a particular achievement Arts and media Music * 1$T, American rapper, singer-songwriter, DJ, and rec ...
lawyer,
Floyd Abrams Floyd Abrams (born in July 9, 1936) is an American attorney at Cahill Gordon & Reindel. He is an expert on constitutional law and has argued in 13 cases before the Supreme Court of the United States. Abrams represented ''The New York Times'' i ...
, is representing the tobacco companies in the case, contending requiring graphic warning labels on a lawful product cannot withstand constitutional scrutiny. The
Association of National Advertisers The Association of National Advertisers (ANA) represents the marketing community in the United States. Its headquarters is in New York City and it has another office in Washington, D.C. ANA's membership includes over 600 companies with 25,000 br ...
and the
American Advertising Federation The American Advertising Federation (AAF), headquartered in Washington, D.C., is the oldest national advertising trade association in the United States. The AAF also has 15 district operations, each located in and representing a different region o ...
have also filed a brief in the suit, arguing that the labels infringe on commercial free speech and could lead to further government intrusion if left unchallenged. In November 2011, Federal judge Richard Leon of the U.S. District Court for the District of Columbia temporarily halted the new labels, likely delaying the requirement that tobacco companies display the labels. The
U.S. Supreme Court The Supreme Court of the United States (SCOTUS) is the highest court in the federal judiciary of the United States. It has ultimate appellate jurisdiction over all U.S. federal court cases, and over state court cases that involve a point o ...
ultimately could decide the matter. In July 2017, the FDA announced a plan that would reduce the current levels of nicotine permitted in tobacco cigarettes.


Regulation of living organisms

With acceptance of premarket notification 510(k) k033391 in January 2004, the FDA granted Dr. Ronald Sherman permission to produce and market
medical maggots Maggot therapy (also known as larval therapy) is a type of biotherapy involving the introduction of live, disinfected maggots (fly larvae) into non-healing skin and soft-tissue wounds of a human or other animal for the purpose of cleaning out th ...
for use in humans or other animals as a prescription medical device. Medical maggots represent the first living organism allowed by the Food and Drug Administration for production and marketing as a prescription medical device. In June 2004, the FDA cleared ''
Hirudo medicinalis ''Hirudo medicinalis'', the European medicinal leech, is one of several species of leeches used as "medicinal leeches". Other species of ''Hirudo'' sometimes also used as medicinal leeches include '' H. orientalis'', ''H. troctina'', and '' H. ...
'' (medicinal leeches) as the second living organism to be used as a medical device. The FDA also requires milk to be
pasteurized Pasteurization American and British English spelling differences#-ise, -ize (-isation, -ization), or pasteurisation is a process of food preservation in which packaged and non-packaged foods (such as milk and fruit juices) are treated with mi ...
to remove bacteria.


International Cooperation

In February 2011, President
Barack Obama Barack Hussein Obama II ( ; born August 4, 1961) is an American politician who served as the 44th president of the United States from 2009 to 2017. A member of the Democratic Party, Obama was the first African-American president of the U ...
and Canadian Prime Minister
Stephen Harper Stephen Joseph Harper (born April 30, 1959) is a Canadian politician who served as the 22nd prime minister of Canada from 2006 to 2015. Harper is the first and only prime minister to come from the modern-day Conservative Party of Canada, ...
issued a "Declaration on a Shared Vision for Perimeter Security and Economic Competitiveness" and announced the creation of the Canada-United States Regulatory Cooperation Council (RCC) "to increase regulatory transparency and coordination between the two countries." Under the RCC mandate, the FDA and
Health Canada Health Canada (HC; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary unit ...
undertook a "first of its kind" initiative by selecting "as its first area of alignment common cold indications for certain over-the-counter
antihistamine Antihistamines are drugs which treat allergic rhinitis, common cold, influenza, and other allergies. Typically, people take antihistamines as an inexpensive, generic (not patented) drug that can be bought without a prescription and provides re ...
ingredients (GC 2013-01-10)." A more recent example of the FDA's international work is their 2018 cooperation with regulatory and law-enforcement agencies worldwide through
Interpol The International Criminal Police Organization (ICPO; french: link=no, Organisation internationale de police criminelle), commonly known as Interpol ( , ), is an international organization that facilitates worldwide police cooperation and cri ...
as part of Operation Pangea XI. The FDA targeted 465 websites that illegally sold potentially dangerous, unapproved versions of
opioid Opioids are substances that act on opioid receptors to produce morphine-like effects. Medically they are primarily used for pain relief, including anesthesia. Other medical uses include suppression of diarrhea, replacement therapy for opioid us ...
,
oncology Oncology is a branch of medicine that deals with the study, treatment, diagnosis and prevention of cancer. A medical professional who practices oncology is an ''oncologist''. The name's etymological origin is the Greek word ὄγκος (''ó ...
, and
antiviral Antiviral drugs are a class of medication used for treating viral infections. Most antivirals target specific viruses, while a broad-spectrum antiviral is effective against a wide range of viruses. Unlike most antibiotics, antiviral drugs do no ...
prescription drugs to U.S. consumers. The agency focused on transaction laundering schemes in order to uncover the complex online drug network.


Science and research programs

The FDA carries out research and development activities to develop technology and standards that support its regulatory role, with the objective of resolving scientific and technical challenges before they become
impediment An obstacle (also called a barrier, impediment, or stumbling block) is an object, thing, action or situation that causes an obstruction. Different types of obstacles include physical, economic, biopsychosocial, cultural, political, technological ...
s. The FDA's research efforts include the areas of biologics, medical devices, drugs, women's health, toxicology, food safety and applied nutrition, and veterinary medicine.


Data management

The FDA has collected a large amount of data through the decades. The
OpenFDA OpenFDA is a project indexing and formatting Food and Drug Administration, FDA data, and making it accessible to the public. The ultimate goal of enabling the data accessibility is to educate people and save lives. The currently provided API of a ...
project was created to enable easy access of the data for the public and was officially launched in June 2014.


History

Up until the 20th century, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals, with one exception being the short-lived
Vaccine Act of 1813 The Vaccine Act of 1813 was an Act of the Twelfth Congress of the United States to encourage vaccination against smallpox. It was passed 27 February 1813 and repealed 4 May 1822. The Act was the first federal law concerning consumer protection a ...
. The history of the FDA can be traced to the latter part of the 19th century and the Division of Chemistry of the
U.S. Department of Agriculture The United States Department of Agriculture (USDA) is the federal executive department responsible for developing and executing federal laws related to farming, forestry, rural economic development, and food. It aims to meet the needs of com ...
, which was itself derived from the
Copyright and Patent Clause The Copyright Clause (also known as the Intellectual Property Clause, Copyright and Patent Clause, or the Progress Clause) describes an enumerated power listed in the United States Constitution ( Article I, Section 8, Clause 8). The clause, w ...
. Under
Harvey Washington Wiley Harvey Washington Wiley (October 18, 1844 – June 30, 1930) was an American chemist who fought for the passage of the landmark Pure Food and Drug Act of 1906 and subsequently worked at the Good Housekeeping, Good Housekeeping Institute la ...
, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market. Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by
muckraking The muckrakers were reform-minded journalists, writers, and photographers in the Progressive Era in the United States (1890s–1920s) who claimed to expose corruption and wrongdoing in established institutions, often through sensationalist publ ...
journalists like
Upton Sinclair Upton Beall Sinclair Jr. (September 20, 1878 – November 25, 1968) was an American writer, muckraker, political activist and the 1934 Democratic Party nominee for governor of California who wrote nearly 100 books and other works in seve ...
, and became part of a general trend for increased federal regulations in matters pertinent to public safety during the
Progressive Era The Progressive Era (late 1890s – late 1910s) was a period of widespread social activism and political reform across the United States focused on defeating corruption, monopoly, waste and inefficiency. The main themes ended during Am ...
. The Biologics Control Act of 1902 was put in place after a
diphtheria Diphtheria is an infection caused by the bacterium '' Corynebacterium diphtheriae''. Most infections are asymptomatic or have a mild clinical course, but in some outbreaks more than 10% of those diagnosed with the disease may die. Signs and s ...
antitoxin derived from tetanus-contaminated serum caused the deaths of thirteen children in St. Louis, Missouri. The serum was originally collected from a horse named
Jim Jim or JIM may refer to: * Jim (given name), a given name * Jim, a diminutive form of the given name James * Jim, a short form of the given name Jimmy * OPCW-UN Joint Investigative Mechanism * ''Jim'' (comics), a series by Jim Woodring * ''Jim ...
who had contracted tetanus. In June 1906, President
Theodore Roosevelt Theodore Roosevelt Jr. ( ; October 27, 1858 – January 6, 1919), often referred to as Teddy or by his initials, T. R., was an American politician, statesman, soldier, conservationist, naturalist, historian, and writer who served as the 26t ...
signed into law the
Pure Food and Drug Act of 1906 The Pure Food and Drug Act of 1906, also known as Dr. Wiley's Law, was the first of a series of significant consumer protection laws which was enacted by Congress in the 20th century and led to the creation of the Food and Drug Administration. ...
, also known as the "Wiley Act" after its chief advocate. The Act prohibited, under penalty of seizure of goods, the interstate transport of food that had been "adulterated". The Act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the ''
United States Pharmacopeia The ''United States Pharmacopeia'' (''USP'') is a pharmacopeia (compendium of drug information) for the United States published annually by the United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that ...
'' or the ''
National Formulary A formulary is a list of pharmaceutical drugs, often decided upon by a group of people, for various reasons such as insurance coverage or use at a medical facility. Traditionally, a formulary contained a collection of formulas for the compounding ...
''. The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry. Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of foods with chemical additives, but the Chemistry Bureau's authority was soon checked by judicial decisions, which narrowly defined the bureau's powers and set high standards for proof of fraudulent intent. In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide Administration. This name was shortened to the Food and Drug Administration (FDA) three years later. By the 1930s,
muckraking The muckrakers were reform-minded journalists, writers, and photographers in the Progressive Era in the United States (1890s–1920s) who claimed to expose corruption and wrongdoing in established institutions, often through sensationalist publ ...
journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products that had been ruled permissible under the 1906 law, including
radioactive Radioactive decay (also known as nuclear decay, radioactivity, radioactive disintegration, or nuclear disintegration) is the process by which an unstable atomic nucleus loses energy by radiation. A material containing unstable nuclei is consid ...
beverages A drink or beverage is a liquid intended for human consumption. In addition to their basic function of satisfying thirst, drinks play important roles in human culture. Common types of drinks include plain drinking water, milk, juice, smoothies a ...
, the mascara Lash lure which caused blindness, and worthless "cures" for
diabetes Diabetes, also known as diabetes mellitus, is a group of metabolic disorders characterized by a high blood sugar level ( hyperglycemia) over a prolonged period of time. Symptoms often include frequent urination, increased thirst and increased ap ...
and
tuberculosis Tuberculosis (TB) is an infectious disease usually caused by '' Mycobacterium tuberculosis'' (MTB) bacteria. Tuberculosis generally affects the lungs, but it can also affect other parts of the body. Most infections show no symptoms, in ...
. The resulting proposed law was unable to get through the
Congress of the United States The United States Congress is the legislature of the federal government of the United States. It is Bicameralism, bicameral, composed of a lower body, the United States House of Representatives, House of Representatives, and an upper body, ...
for five years, but was rapidly enacted into law following the public outcry over the 1937
Elixir Sulfanilamide Elixir sulfanilamide was an improperly prepared sulfonamide antibiotic that caused mass poisoning in the United States in 1937. It is believed to have killed more than 100 people. The public outcry caused by this incident and other similar disast ...
tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent. President
Franklin Delano Roosevelt Franklin Delano Roosevelt (; ; January 30, 1882April 12, 1945), often referred to by his initials FDR, was an American politician and attorney who served as the 32nd president of the United States from 1933 until his death in 1945. As the ...
signed the
Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...
into law on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove
fraudulent intent Bad faith (Latin: ''mala fides'') is a sustained form of deception which consists of entertaining or pretending to entertain one set of feelings while acting as if influenced by another."of two hearts ... a sustained form of deception which ...
. Soon after passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of " prescription-only" drugs was securely codified into law by the Durham-Humphrey Amendment in 1951. These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs. Outside of the US, the drug
thalidomide Thalidomide, sold under the brand names Contergan and Thalomid among others, is a medication used to treat a number of cancers (including multiple myeloma), graft-versus-host disease, and a number of skin conditions including complications of ...
was marketed for the relief of general nausea and
morning sickness Morning sickness, also called nausea and vomiting of pregnancy (NVP), is a symptom of pregnancy that involves nausea or vomiting. Despite the name, nausea or vomiting can occur at any time during the day. Typically the symptoms occur between th ...
, but caused birth defects and even the death of thousands of babies when taken during pregnancy. American mothers were largely unaffected as Dr.
Frances Oldham Kelsey Frances Kathleen Kelsey ( Oldham; July 24, 1914 – August 7, 2015) was a Canadian-American pharmacologist and physician. As a reviewer for the U.S. Food and Drug Administration (FDA), she refused to authorize thalidomide for market because sh ...
of the FDA refused to authorize the medication for market. In 1962, the Kefauver-Harris Amendment to the FD&C Act was passed, which represented a "revolution" in FDA regulatory authority. The most important change was the requirement that all new drug applications demonstrate "substantial evidence" of the drug's efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety. This marked the start of the FDA approval process in its modern form. These reforms had the effect of increasing the time, and the difficulty, required to bring a drug to market. One of the most important statutes in establishing the modern American pharmaceutical market was the 1984
Drug Price Competition and Patent Term Restoration Act The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that encourages the manufacture of generic drugs by the pharmaceutical industry and es ...
, more commonly known as the "Hatch-Waxman Act" after its chief sponsors. The act extended the patent exclusivity terms of new drugs, and tied those extensions, in part, to the length of the FDA approval process for each individual drug. For generic manufacturers, the Act created a new approval mechanism, the
Abbreviated New Drug Application An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to Food and Drug Administration, FDA's Center for Drug Evaluation and Resea ...
(ANDA), in which the generic drug manufacturer need only demonstrate that their generic formulation has the same active ingredient, route of administration, dosage form, strength, and
pharmacokinetic Pharmacokinetics (from Ancient Greek ''pharmakon'' "drug" and ''kinetikos'' "moving, putting in motion"; see chemical kinetics), sometimes abbreviated as PK, is a branch of pharmacology dedicated to determining the fate of substances administered ...
properties ("bioequivalence") as the corresponding brand-name drug. This Act has been credited with, in essence, creating the modern generic drug industry. Concerns about the length of the drug approval process were brought to the fore early in the AIDS epidemic. In the mid- and late 1980s,
ACT-UP AIDS Coalition to Unleash Power (ACT UP) is an international, grassroots political group working to end the AIDS pandemic. The group works to improve the lives of people with AIDS through direct action, medical research, treatment and advocacy, ...
and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections. Partly in response to these criticisms, the FDA issued new rules to expedite approval of drugs for life-threatening diseases, and expanded pre-approval access to drugs for patients with limited treatment options. All of the initial drugs approved for the treatment of HIV/AIDS were approved through these accelerated approval mechanisms. Frank Young, then commissioner of the FDA, was behind the Action Plan Phase II, established in August 1987 for quicker approval of AIDS medication. In two instances, state governments have sought to legalize drugs that the FDA has not approved. Under the theory that federal law, passed pursuant to Constitutional authority, overrules conflicting state laws, federal authorities still claim the authority to seize, arrest, and prosecute for possession and sales of these substances, even in states where they are legal under state law. The first wave was the legalization by 27 states of
laetrile Amygdalin (from Ancient Greek: ' "almond") is a naturally occurring chemical compound found in many plants, most notably in the seeds (kernels) of apricots, bitter almonds, apples, peaches, cherries, and plums. Amygdalin is classified as a cya ...
in the late 1970s. This drug was used as a treatment for cancer, but scientific studies both before and after this legislative trend found it to be ineffective. The second wave concerned
medical marijuana Medical cannabis, or medical marijuana (MMJ), is cannabis and cannabinoids that are prescribed by physicians for their patients. The use of cannabis as medicine has not been rigorously tested due to production and governmental restrictions ...
in the 1990s and 2000s. Though Virginia passed legislation allowing doctors to recommend cannabis for glaucoma or the side effects of chemotherapy, a more widespread trend began in California with the
Compassionate Use Act of 1996 Proposition 215, or the Compassionate Use Act of 1996, is a California law permitting the use of medical cannabis despite marijuana's lack of the normal Food and Drug Administration testing for safety and efficacy. It was enacted, on November 5 ...
. When the FDA requested
Endo Pharmaceuticals Endo International plc is an American Irish-domiciled generics and specialty branded pharmaceutical company that generated over 93% of its 2017 sales from the U.S. healthcare system. While Endo's management, operations, and customers are almost ...
on June 8, 2017, to remove ''
oxymorphone hydrochloride Oxymorphone (sold under the brand names Numorphan and Opana among others) is a highly potent opioid analgesic indicated for treatment of severe pain. Pain relief after injection begins after about 5–10 minutes, after oral administration it be ...
'' from the market, it was the first such request in FDA history.


21st century reforms


Critical Path Initiative

The Critical Path Initiative is the FDA's effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured. The Initiative was launched in March 2004, with the release of a report entitled Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.


Patients' rights to access unapproved drugs

The
Compassionate Investigational New Drug program Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug, investigational new drug applications (IND) or Investigational device exemption, IDE application for devices, o ...
was created after ''Randall v. U.S.'' ruled in favor of
Robert C. Randall Robert C. Randall (1948 – June 2, 2001) was an American advocate for medical marijuana and the founder of Alliance for Cannabis Therapeutics. Life and activism Robert Randall was the first legal medical marijuana smoker in the United State ...
in 1978, creating a program for
medical marijuana Medical cannabis, or medical marijuana (MMJ), is cannabis and cannabinoids that are prescribed by physicians for their patients. The use of cannabis as medicine has not been rigorously tested due to production and governmental restrictions ...
. A 2006 court case, ''
Abigail Alliance v. von Eschenbach ''Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach'', 495 F.3d 695 (D.C. Cir. 2007), ''cert denied'', 552 U.S. 1159 (2008) was resolved in early 2008 when the Supreme Court of the United States declined to hear the appea ...
'', would have forced radical changes in FDA regulation of unapproved drugs. The Abigail Alliance argued that the FDA must license drugs for use by terminally ill patients with "desperate diagnoses," after they have completed Phase I testing. The case won an initial appeal in May 2006, but that decision was reversed by a March 2007 rehearing. The
US Supreme Court The Supreme Court of the United States (SCOTUS) is the highest court in the federal judiciary of the United States. It has ultimate appellate jurisdiction over all U.S. federal court cases, and over state court cases that involve a point of ...
declined to hear the case, and the final decision denied the existence of a right to unapproved medications.
Critics A critic is a person who communicates an assessment and an opinion of various forms of creative works such as art, literature, music, cinema, theater, fashion, architecture, and food. Critics may also take as their subject social or governmen ...
of the FDA's regulatory power argue that the FDA takes too long to approve drugs that might ease pain and human suffering faster if brought to market sooner. The AIDS crisis created some political efforts to streamline the approval process. However, these limited reforms were targeted for AIDS drugs, not for the broader market. This has led to the call for more robust and enduring reforms that would allow patients, under the care of their doctors, access to drugs that have passed the first round of clinical trials.


Post-marketing drug safety monitoring

The widely publicized recall of
Vioxx Rofecoxib is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID). It was marketed by Merck & Co. to treat osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, acute pain conditions, migraine, and dysmenorrhea. Rofecoxib ...
, a
non-steroidal anti-inflammatory drug Non-steroidal anti-inflammatory drugs (NSAID) are members of a therapeutic drug class which reduces pain, decreases inflammation, decreases fever, and prevents blood clots. Side effects depend on the specific drug, its dose and duration of ...
(NSAID) now estimated to have contributed to fatal
heart attacks A myocardial infarction (MI), commonly known as a heart attack, occurs when blood flow decreases or stops to the coronary artery of the heart, causing damage to the heart muscle. The most common symptom is chest pain or discomfort which may tra ...
in thousands of Americans, played a strong role in driving a new wave of safety reforms at both the FDA rulemaking and statutory levels. Vioxx was approved by the FDA in 1999 and was initially hoped to be safer than previous NSAIDs, due to its reduced risk of intestinal tract bleeding. However, a number of pre- and post-marketing studies suggested that Vioxx might increase the risk of myocardial infarction, and this was conclusively demonstrated by results from the APPROVe trial in 2004. Faced with numerous lawsuits, the manufacturer voluntarily withdrew it from the market. The example of Vioxx has been prominent in an ongoing debate over whether new drugs should be evaluated on the basis of their absolute safety, or their safety relative to existing treatments for a given condition. In the wake of the Vioxx recall, there were widespread calls by major newspapers, medical journals, consumer advocacy organizations, lawmakers, and FDA officials  Retrieved August 30, 2012. for reforms in the FDA's procedures for pre- and post-market drug safety regulation. In 2006, a
Congressional committee A congressional committee is a legislative sub-organization in the United States Congress that handles a specific duty (rather than the general duties of Congress). Committee membership enables members to develop specialized knowledge of the ...
was appointed by the
Institute of Medicine The National Academy of Medicine (NAM), formerly called the Institute of Medicine (IoM) until 2015, is an American nonprofit, non-governmental organization. The National Academy of Medicine is a part of the National Academies of Sciences, E ...
to review pharmaceutical safety regulation in the U.S. and to issue recommendations for improvements. The committee was composed of 16 experts, including leaders in clinical medicine medical research, economics,
biostatistics Biostatistics (also known as biometry) are the development and application of statistical methods to a wide range of topics in biology. It encompasses the design of biological experiments, the collection and analysis of data from those experime ...
, law, public policy, public health, and the allied health professions, as well as current and former executives from the
pharmaceutical A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and re ...
, hospital, and
health insurance Health insurance or medical insurance (also known as medical aid in South Africa) is a type of insurance that covers the whole or a part of the risk of a person incurring medical expenses. As with other types of insurance, risk is shared among ma ...
industries. The authors found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA. Some of the committee's recommendations were incorporated into drafts of the PDUFA IV amendment, which was signed into law as the
Food and Drug Administration Amendments Act of 2007 President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. The ...
. As of 2011, Risk Minimization Action Plans (RiskMAPS) have been created to ensure risks of a drug never outweigh the benefits of that drug within the post-marketing period. This program requires that manufacturers design and implement periodic assessments of their programs' effectiveness. The Risk Minimization Action Plans are set in place depending on the overall level of risk a prescription drug is likely to pose to the public.


Pediatric drug testing

Prior to the 1990s, only 20% of all drugs prescribed for children in the United States were tested for safety or efficacy in a pediatric population. This became a major concern of
pediatrician Pediatrics ( also spelled ''paediatrics'' or ''pædiatrics'') is the branch of medicine that involves the medical care of infants, children, adolescents, and young adults. In the United Kingdom, paediatrics covers many of their youth until the ...
s as evidence accumulated that the physiological response of children to many drugs differed significantly from those drugs' effects on adults. Children react differently to the drugs because of many reasons, including size, weight, etc. There were several reasons that few medical trials were done with children. For many drugs, children represented such a small proportion of the potential market, that drug manufacturers did not see such testing as cost-effective. Also, because children were thought to be ethically restricted in their ability to give
informed consent Informed consent is a principle in medical ethics and medical law, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatme ...
, there were increased governmental and institutional hurdles to approval of these clinical trials, as well as greater concerns about
legal liability In law, liable means "responsible or answerable in law; legally obligated". Legal liability concerns both civil law and criminal law and can arise from various areas of law, such as contracts, torts, taxes, or fines given by government agenci ...
. Thus, for decades, most medicines prescribed to children in the U.S. were done so in a non-FDA-approved, "off-label" manner, with dosages "extrapolated" from adult data through body weight and body-surface-area calculations. An initial attempt by the FDA to address this issue was the 1994 FDA Final Rule on Pediatric Labeling and Extrapolation, which allowed manufacturers to add pediatric labeling information, but required drugs that had not been tested for pediatric safety and efficacy to bear a disclaimer to that effect. However, this rule failed to motivate many drug companies to conduct additional pediatric drug trials. In 1997, the FDA proposed a rule to require pediatric drug trials from the sponsors of New Drug Applications. However, this new rule was successfully preempted in federal court as exceeding the FDA's statutory authority. While this debate was unfolding, Congress used the
Food and Drug Administration Modernization Act of 1997 The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act. This act is related to the regulation of food, drugs, devices, and biological products by the FDA. These changes ...
to pass incentives that gave pharmaceutical manufacturers a six-month patent term extension on new drugs submitted with pediatric trial data. The Best Pharmaceuticals for Children Act of 2007 reauthorized these provisions and allowed the FDA to request
NIH The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
-sponsored testing for pediatric drug testing, although these requests are subject to NIH funding constraints. In the
Pediatric Research Equity Act of 2003 Pediatrics ( also spelled ''paediatrics'' or ''pædiatrics'') is the branch of medicine that involves the medical care of infants, children, adolescents, and young adults. In the United Kingdom, paediatrics covers many of their youth until the ...
, Congress codified the FDA's authority to mandate manufacturer-sponsored pediatric drug trials for certain drugs as a "last resort" if incentives and publicly funded mechanisms proved inadequate.


Priority review voucher (PRV)

The
priority review voucher Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program ...
is a provision of the
Food and Drug Administration Amendments Act of 2007 President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. The ...
, which awards a transferable "priority review voucher" to any company that obtains approval for a treatment for a
neglected tropical diseases Neglected tropical diseases (NTDs) are a diverse group of tropical disease, tropical infections that are common in low-income populations in Developing country, developing regions of Africa, Asia, and the Americas. They are caused by a variety ...
. The system was first proposed by
Duke University Duke University is a private research university in Durham, North Carolina. Founded by Methodists and Quakers in the present-day city of Trinity in 1838, the school moved to Durham in 1892. In 1924, tobacco and electric power industrialist James ...
faculty David Ridley, Henry Grabowski, and Jeffrey Moe in their 2006 ''
Health Affairs ''Health Affairs'' is a monthly peer-reviewed public health journal, healthcare journal established in 1981 by John K. Iglehart; since 2014, the editor-in-chief is Alan Weil. It was described by ''The Washington Post'' as "the bible of health poli ...
'' paper: "Developing Drugs for Developing Countries". President Obama signed into law the
Food and Drug Administration Safety and Innovation Act of 2012 The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user ...
which extended the authorization until 2017.


Rules for generic biologics

Since the 1990s, many successful new drugs for the treatment of cancer,
autoimmune diseases An autoimmune disease is a condition arising from an abnormal immune response to a functioning body part. At least 80 types of autoimmune diseases have been identified, with some evidence suggesting that there may be more than 100 types. Nearly a ...
, and other conditions have been
protein Proteins are large biomolecules and macromolecules that comprise one or more long chains of amino acid residues. Proteins perform a vast array of functions within organisms, including catalysing metabolic reactions, DNA replication, respo ...
-based biotechnology drugs, regulated by the
Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Dir ...
. Many of these drugs are extremely expensive; for example, the anti-cancer drug
Avastin Bevacizumab, sold under the brand name Avastin among others, is a medication used to treat a number of types of cancers and a specific eye disease. For cancer, it is given by slow injection into a vein (Intravenous therapy, intravenous) and use ...
costs $55,000 for a year of treatment, while the
enzyme replacement therapy Enzyme replacement therapy (ERT) is a medical treatment which replaces an enzyme that is deficient or absent in the body. Usually, this is done by giving the patient an intravenous (IV) infusion of a solution containing the enzyme. ERT is availab ...
drug
Cerezyme Imiglucerase is a medication used in the treatment of Gaucher's disease. It is a recombinant DNA-produced analogue of the human enzyme β-glucocerebrosidase. Cerezyme is a freeze-dried medicine containing imiglucerase, manufactured by Genzyme Co ...
costs $200,000 per year, and must be taken by
Gaucher's Disease Gaucher's disease or Gaucher disease () (GD) is a genetic disorder A genetic disorder is a health problem caused by one or more abnormalities in the genome. It can be caused by a mutation in a single gene (monogenic) or multiple genes (polyg ...
patients for life. Biotechnology drugs do not have the simple, readily verifiable chemical structures of conventional drugs, and are produced through complex, often proprietary, techniques, such as transgenic mammalian cell cultures. Because of these complexities, the 1984
Hatch-Waxman Act The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that encourages the manufacture of generic drugs by the pharmaceutical industry and es ...
did not include biologics in the
Abbreviated New Drug Application An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to Food and Drug Administration, FDA's Center for Drug Evaluation and Resea ...
(ANDA) process. This precluded the possibility of generic drug competition for biotechnology drugs. In February 2007, identical bills were introduced into the House to create an ANDA process for the approval of generic biologics, but were not passed.


Mobile medical applications

In 2013, a guidance was issued to regulate mobile medical applications and protect users from their unintended use. This guidance distinguishes the apps subjected to regulation based on the marketing claims of the apps. Incorporation of the guidelines during the development phase of these apps has been proposed for expedited market entry and clearance.


Criticism

The FDA has regulatory oversight over a large array of products that affect the health and life of American citizens. As a result, the FDA's powers and decisions are carefully monitored by several governmental and non-governmental organizations. A $1.8million 2006
Institute of Medicine The National Academy of Medicine (NAM), formerly called the Institute of Medicine (IoM) until 2015, is an American nonprofit, non-governmental organization. The National Academy of Medicine is a part of the National Academies of Sciences, E ...
report on pharmaceutical regulation in the U.S. found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.Webcitation.org
/ref> A 2022 article from
Politico ''Politico'' (stylized in all caps), known originally as ''The Politico'', is an American, German-owned political journalism newspaper company based in Arlington County, Virginia, that covers politics and policy in the United States and intern ...
raised concerns that food is not a high priority at the FDA. The report explains the FDA has structural and leadership problems in the food division and is often deferential to industry. This might be attributed to
lobbying In politics, lobbying, persuasion or interest representation is the act of lawfully attempting to influence the actions, policies, or decisions of government officials, most often legislators or members of regulatory agency, regulatory agencie ...
and influence of big food companies in Washington, D.C. During the COVID-19 pandemic, the FDA received criticism for punishing small distilleries that made hand sanitizers to help meet the unexpected demand. After receiving $14,000 fines from the FDA, some producers stated, "I wish we'd never done it. I will not put myself on this same chopping block again."


See also

*
Adverse reaction An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. The term complica ...
*
Adverse event An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can ther ...
*
Adverse drug reaction An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this term ...
*
Biosecurity Biosecurity refers to measures aimed at preventing the introduction and/or spread of harmful organisms (e.g. viruses, bacteria, etc.) to animals and plants in order to minimize the risk of transmission of infectious disease. In agriculture, thes ...
*
Biosecurity in the United States Biosecurity in the United States is governed by the Bureau of Western Hemisphere Affairs, which is part of the US Department of State. It obtains guidance and advice on specific matters relating to biosecurity from various other government agencies. ...
*
Drug Efficacy Study Implementation Drug Efficacy Study Implementation (DESI) was a program begun by the Food and Drug Administration (FDA) in the 1960s after the requirement (in the Kefauver-Harris Drug Control Act) that all drugs be efficacious as well as safe, was made part of US ...
*
Food and Drug Administration Modernization Act of 1997 The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act. This act is related to the regulation of food, drugs, devices, and biological products by the FDA. These changes ...
* FDA Food Safety Modernization Act of 2011 *
FDA Fast Track Development Program Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical ne ...
(for drugs) *
Food and Drug Administration Amendments Act of 2007 President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. The ...
(e.g. drugs) *
Food and Drug Administration Safety and Innovation Act of 2012 The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user ...
(GAIN/QIDP etc.) *
Inverse benefit law The inverse benefit law states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively a drug is marketed. Two Americans, Howard Brody and Donald Light, have defined the inverse benefit law, ...
* Investigational Device Exemption (for use in clinical trials) *
Kefauver Harris Amendment Carey Estes Kefauver (; July 26, 1903 – August 10, 1963) was an American politician from Tennessee. A member of the Democratic Party, he served in the U.S. House of Representatives from 1939 to 1949 and in the Senate from 1949 until his de ...
1962 – required "proof-of-efficacy" for drugs International: * Food Administration *
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pha ...
(ICH) * African Union:
African Medicines Agency The African Medicines Agency (AMA) is a proposed specialised agency of the African Union (AU) intended to facilitate the harmonisation of medical regulation throughout the African Union. Following a similar model to that of the European Medicin ...
* Australia:
Therapeutic Goods Administration The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health and Aged Care, the TGA regulates the quality, supply and advertising of medicines, pa ...
* Brazil:
National Health Surveillance Agency Brazilian Health Regulatory Agency ( pt, Agência Nacional de Vigilância Sanitária, links=no, italics=yes, ''Anvisa'', literally National Health Surveillance Agency) is a regulatory body of the Brazilian government, created in 1999 during Presi ...
* Canada:
Marketed Health Products Directorate The Marketed Health Products Directorate (MHPD) is the Canadian federal authority that monitors the safety and effectiveness of health products marketed in Canada. These include: * Prescription and non-prescription medications * Biologic medical pro ...
* Canada:
Health Canada Health Canada (HC; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary unit ...
* Denmark:
Danish Medicines Agency The Danish Medicines Agency (Lægemiddelstyrelsen) is an agency under the Danish Ministry of Health and Prevention. The purpose of the agency is to ensure that medicinal products used in Denmark are of satisfactory quality, are safe to use and tha ...
* European Union:
European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...
* Germany:
Federal Institute for Drugs and Medical Devices The Federal Institute for Drugs and Medical Devices (in German: Bundesinstitut für Arzneimittel und Medizinprodukte – ''BfArM'') is the medical regulatory body in Germany. It operates under the Federal Ministry of Health (BMG). It is headquarte ...
* India:
Food Safety and Standards Authority of India Food Safety and Standards Authority of India (FSSAI) is a statutory body established under the Ministry of Health & Family Welfare, Government of India. The FSSAI has been established under the Food Safety and Standards Act, 2006, which is a co ...
* India:
Central Drugs Standard Control Organization The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics , pharmaceuticals and medical devices. It serves a similar function to the European Medicines Agency of the European Union, the PMDA of Jap ...
* Japan:
Ministry of Health, Labour and Welfare The is a cabinet level ministry of the Japanese government. It is commonly known as in Japan. The ministry provides services on health, labour and welfare. It was formed with the merger of the former Ministry of Health and Welfare or and the ...
(MHLW) * Japan:
Pharmaceuticals and Medical Devices Agency The (PhMDA) is an Independent Administrative Institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. It is similar in function to the Food and Drug Administration in the United State ...
* Mexico:
Federal Commission for the Protection against Sanitary Risk The Federal Commission for Protection against Health Risks (in Spanish, Comisión Federal para la Protección contra Riesgos Sanitarios, Cofepris) is a regulatory body of the Mexican government. It is a decentralized organ of (and supervised by) t ...
* Philippines:
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA) * Singapore:
Health Sciences Authority The Health Sciences Authority (HSA) is a statutory board under the Ministry of Health of the Government of Singapore. It is a multi-disciplinary agency, responsible for applying medical, pharmaceutical and scientific expertise to protect and ...
* United Kingdom:
Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably ...
* United States: Food and Drug Administration


Notes


References


Further reading

* Givel, Michael (December 2005). "Philip Morris' FDA Gambit: Good for Public Health?" ''Journal of Public Health Policy'' (26): pp. 450–468 * * Hilts, Philip J. (2003). ''Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation.'' New York: Alfred E. Knopf. * Kevin Fain, Matthew Daubresse, G. Caleb Alexander (2013). "The Food and Drug Administration Amendments Act and Postmarketing Commitments." "JAMA" 310(2): 202–204 . * Madden, Bartley (2010) ''Free To Choose Medicine: How Faster Access to New Drugs Would Save Countless Lives and End Needless Suffering'' Chicago: The
Heartland Institute The Heartland Institute is an American conservative and libertarian public policy think tank known for its rejection of both the scientific consensus on climate change and the negative health impacts of smoking. Founded in 1984, it worked wit ...
. * Moore, Thomas J. (1998). ''Prescription for Disaster: The Hidden Dangers in Your Medicine Cabinet.'' New York: Simon & Schuster. * Obenchain, Janel, and Arlene Spark. Food Policy: Looking Forward from the Past. CRC Press, 2015. * Shah, Soleil, and
Abdul El-Sayed Abdulrahman Mohamed El-Sayed (born October 31, 1984) is an American politician, former public health professor, medical doctor, and civil servant. He was a candidate in Michigan's 2018 Democratic gubernatorial primary election, placing second ou ...
, "Medical Algorithms Need Better Regulation: Many do not require FDA approval, and those that do often do not undergo clinical trials", ''
Scientific American ''Scientific American'', informally abbreviated ''SciAm'' or sometimes ''SA'', is an American popular science magazine. Many famous scientists, including Albert Einstein and Nikola Tesla, have contributed articles to it. In print since 1845, it i ...
'', vol. 326, no. 1 (January 2022), pp. 10–11. "Medical algorithms are less transparent, far more complex, more likely to reflect preexisting human bias, and more apt to evolve (and fail) over time than medical devices in the past." (p. 11.)


External links

*
Food and Drug Administration
in the
Federal Register The ''Federal Register'' (FR or sometimes Fed. Reg.) is the official journal of the federal government of the United States that contains government agency rules, proposed rules, and public notices. It is published every weekday, except on feder ...

FDA Organizational Hierarchy Chart
in PDF format
Strategic Plan
*
Online books by United States Food and Drug Administration
at
The Online Books Page The Online Books Page is an index of e-text books available on the Internet. It is edited by John Mark Ockerbloom and is hosted by the library of the University of Pennsylvania. The Online Books Page lists over 2 million books and has several feat ...
{{DEFAULTSORT:Food And Drug Administration (United States) 1906 establishments in the United States American medical research Government agencies established in 1906 Regulators of biotechnology products