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Franklin V. Parke-Davis
''Franklin v. Parke-Davis'' is a lawsuit filed in 1996 against Parke-Davis, a division of Warner-Lambert Company, and eventually against Pfizer (which bought Warner-Lambert in 2000) under the ''qui tam'' provisions of the False Claims Act.U.S. ex rel. Franklin v. Parke-Davis, Div. of Warner-Lambert Co., No. CIV.A.96–11651PBS, 2003 WL 22048255, at *1 (D. Mass. Aug. 22, 20032003 Decision/ref> The suit was commenced by David Franklin, a microbiologist hired in the spring of 1996 in a sales capacity at Parke-Davis, a pharmaceutical subsidiary of Warner-Lambert (Warner-Lambert was subsequently acquired by Pfizer in 2000).Melody Petersen, ''Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs'', New York: Sarah Crichton Books (2008). In denying the defendants' motion for summary judgment, the court for the first time recognized off-label promotion of drugs could cause Medicaid to pay for pre ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States District Court For The District Of Massachusetts
The United States District Court for the District of Massachusetts (in case citations, D. Mass.) is the federal district court whose territorial jurisdiction is the Commonwealth of Massachusetts, United States. The first court session was held in Boston in 1789. The second term was held in Salem in 1790 and court session locations alternated between the two cities until 1813. That year, Boston became the court's permanent home. A western division was opened in Springfield in 1979 and a central division was opened in Worcester in 1987. The court's main building is the John Joseph Moakley Federal Courthouse on Fan Pier in South Boston. Appeals from the District of Massachusetts are heard by the United States Court of Appeals for the First Circuit, also located in the Moakley courthouse (except for patent claims and claims against the U.S. government under the Tucker Act, which are appealed to the Federal Circuit). U.S. Attorney's Office The United States Attorney's Office ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (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 d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Consumer & Prescriber Grant Program
The Consumer & Prescriber Grant Program (also going by other names, including Attorney General Prescriber Grant Program) was a grant program established with fines paid by Pfizer in the ''Franklin v. Parke-Davis'' trial for False Claims Act violations relating to off-label use of gabapentin. Grant recipients There were 24 original grant recipients. *Oregon State University *"Education about Heavily Marketed Drugs" * PharmedOut *Federation of State Medical Boards *Robert Larner College of Medicine *The Pew Charitable Trusts *American Medical Association The American Medical Association (AMA) is a professional association and lobbying group of physicians and medical students. Founded in 1847, it is headquartered in Chicago, Illinois. Membership was approximately 240,000 in 2016. The AMA's state ... References External linksOfficial websitearchival copy from March 2011. The website existed from 2008-2011. Grants (money) Off-label drug use {{DEFAULTSORT:Consumer and Pres ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was us ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Department Of Justice
The United States Department of Justice (DOJ), also known as the Justice Department, is a federal executive department of the United States government tasked with the enforcement of federal law and administration of justice in the United States. It is equivalent to the justice or interior ministries of other countries. The department is headed by the U.S. attorney general, who reports directly to the president of the United States and is a member of the president's Cabinet. The current attorney general is Merrick Garland, who was sworn in on March 11, 2021. The modern incarnation of the Justice Department was formed in 1870 during the Ulysses S. Grant presidency. The department comprises federal law enforcement agencies, including the Federal Bureau of Investigation, the U.S. Marshals Service, the Bureau of Alcohol, Tobacco, Firearms and Explosives, the Drug Enforcement Administration, and the Federal Bureau of Prisons. It also has eight major divisions of lawyers who rep ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Formulary (pharmacy)
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 and testing of medication (a resource closer to what would be referred to as a pharmacopoeia today). Today, the main function of a prescription formulary is to specify particular medications that are approved to be prescribed at a particular hospital, in a particular health system, or under a particular health insurance policy. The development of prescription formularies is based on evaluations of efficacy, safety, and cost-effectiveness of drugs. Depending on the individual formulary, it may also contain additional clinical information, such as side effects, contraindications, and doses. By the turn of the millennium, 156 countries had national or provincial essential medicines lists and 135 countries had national treatment. Australia ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Attention Deficit Disorder
Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterised by excessive amounts of inattention, hyperactivity, and impulsivity that are pervasive, impairing in multiple contexts, and otherwise Developmental psychology, age-inappropriate. ADHD symptoms arise from executive dysfunction, and emotional dysregulation is often considered a core symptom. In children, problems paying attention may result in poor Academic achievement, school performance. ADHD is associated with other neurodevelopmental and mental disorders as well as some non-psychiatric disorders, which can cause additional impairment, especially in modern society. Although people with ADHD struggle to focus on tasks they are not particularly interested in completing, they are often able to maintain an unusually prolonged and intense level of attention for tasks they do find interesting or rewarding; this is known as hyperfocus. The precise causes of ADHD are unknown in the majo ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Case Report
In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. Some case reports also contain a literature review of other reported cases. Case reports are professional narratives that provide feedback on clinical practice guidelines and offer a framework for early signals of effectiveness, adverse events, and cost. They can be shared for medical, scientific, or educational purposes. Types Most case reports are on one of six topics: * An unexpected association between diseases or symptoms. * An unexpected event in the course of observing or treating a patient. * Findings that shed new light on the possible pathogenesis of a disease or an adverse effect. * Unique or rare features of a disease. * Unique therapeutic approaches. * A positional or quantitative variation of the anatomical structures. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quid Pro Quo
Quid pro quo ('what for what' in Latin) is a Latin phrase used in English to mean an exchange of goods or services, in which one transfer is contingent upon the other; "a favor for a favor". Phrases with similar meanings include: "give and take", "tit for tat", "you scratch my back, and I'll scratch yours", and "one hand washes the other". Other languages use other phrases for the same purpose. Origins The Latin phrase ''quid pro quo'' originally implied that something had been substituted, as in ''this instead of that''. Early usage by English speakers followed the original Latin meaning, with occurrences in the 1530s where the term referred to substituting one medicine for another, whether unintentionally or fraudulently. By the end of the same century, ''quid pro quo'' evolved into a more current use to describe equivalent exchanges. In 1654, the expression ''quid pro quo'' was used to generally refer to something done for personal gain or with the expectation of reciprocity ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Kickback (bribery)
A kickback is a form of negotiated bribery in which a commission is paid to the bribe-taker in exchange for services rendered. Generally speaking, the remuneration (money, goods, or services handed over) is negotiated ahead of time. The kickback varies from other kinds of bribes in that there is implied collusion between agents of the two parties, rather than one party extorting the bribe from the other.Wrage, Alexandra Addison. ''Bribery and Extortion: Undermining Business, Governments, and Security.'' Westport, Conn.: Praeger Security International, 2007. p. 14. The purpose of the kickback is usually to encourage the other party to cooperate in the scheme.Kranacher, Riley, and Wells, p. 387. The term "kickback" comes from colloquial English language, and describes the way a recipient of illegal gain "kicks back" a portion of it to another person for that person's assistance in obtaining it.Campos, p. 299. Types and methods The most common form of kickback involves a vendor sub ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Science Liaison
A medical science liaison (MSL) is a healthcare consulting professional who is employed by pharmaceutical, biotechnology, medical device, and managed care companies. Other job titles for medical science liaisons may include medical liaisons, clinical science liaisons, medical science managers, regional medical scientists, and regional medical directors. The term "MSL" was originally trademarked by Upjohn as "Education services – namely, initiation of drug studies in laboratory and clinical settings and development of workshops, symposia, and seminars for physicians, medical societies, specialty organizations, academicians, in concert, concerned with drug related medical topics" in 1967 and with first use in commerce in 1967. As the number of MSL programs in healthcare increased, subsequent peer-reviewed journal publications and books became available to examine the emerging role of medical affairs and the use of MSLs in an increasingly vertically integrated biotechnology industry. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Attention-deficit Disorder
Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterised by excessive amounts of inattention, hyperactivity, and impulsivity that are pervasive, impairing in multiple contexts, and otherwise age-inappropriate. ADHD symptoms arise from executive dysfunction, and emotional dysregulation is often considered a core symptom. In children, problems paying attention may result in poor school performance. ADHD is associated with other neurodevelopmental and mental disorders as well as some non-psychiatric disorders, which can cause additional impairment, especially in modern society. Although people with ADHD struggle to focus on tasks they are not particularly interested in completing, they are often able to maintain an unusually prolonged and intense level of attention for tasks they do find interesting or rewarding; this is known as hyperfocus. The precise causes of ADHD are unknown in the majority of cases. Genetic factors play an impor ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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