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Marketing Of Off-label Use
Marketing of off-label use is advertising the use of drugs for purposes not approved by the regional government. The practice is often illegal and has led to most of the largest pharmaceutical settlements after '' Franklin v. Parke-Davis'', in which a court ruled off-label marketing a violation of the False Claims Act. List of off-label promotion pharmaceutical settlements Many of the conflicts among the list of largest pharmaceutical settlements were because of off-label promotion. Franklin v. Parke-Davis In 1993, the FDA approved gabapentin, marketed by Pfizer under the name "Neurontin", only for treatment of seizures. Pfizer subsidiary Warner-Lambert illegally used scientific activities, including continuing medical education and research, to commercially promote gabapentin, so that within five years the drug was being widely used for the off-label treatment of pain and psychiatric conditions—conditions that had not been approved by FDA. In 2004, Warner-Lambert admitted ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutical Marketing
Many countries have measures in place to limit advertising by pharmaceutical companies. Pharmaceutical company spending on marketing generally exceeds that of its research budget. In Canada, $1.7 billion was spent in 2004 to market drugs to physicians; in the United States, $21 billion was spent in 2002. In 2005, money spent on pharmaceutical marketing in the United States was estimated at $29.9 billion with one estimate as high as $57 billion. When the U.S. numbers are broken down, 56% was free samples, 25% was pharmaceutical sales representative "detailing" (promoting drugs directly to) physicians, 12.5% was direct to user advertising, 4% on detailing to hospitals, and 2% on journal ads. There is some evidence that marketing practices can negatively affect both patients and the health care profession. To health care providers Marketing to health-care providers takes three main forms: activity by pharmaceutical sales representatives, provision of drug samples, and sponsoring ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Research
Medical research (or biomedical research), also known as experimental medicine, encompasses a wide array of research, extending from " basic research" (also called ''bench science'' or ''bench research''), – involving fundamental scientific principles that may apply to a ''preclinical'' understanding – to clinical research, which involves studies of people who may be subjects in clinical trials. Within this spectrum is applied research, or translational research, conducted to expand knowledge in the field of medicine. Both clinical and preclinical research phases exist in the pharmaceutical industry's drug development pipelines, where the clinical phase is denoted by the term ''clinical trial''. However, only part of the clinical or preclinical research is oriented towards a specific pharmaceutical purpose. The need for fundamental and mechanism-based understanding, diagnostics, medical devices, and non-pharmaceutical therapies means that pharmaceutical research ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
First Amendment To The United States Constitution
The First Amendment (Amendment I) to the United States Constitution prevents the government from making laws that regulate an establishment of religion, or that prohibit the free exercise of religion, or abridge the freedom of speech, the freedom of the press, the freedom of assembly, or the right to petition the government for redress of grievances. It was adopted on December 15, 1791, as one of the ten amendments that constitute the Bill of Rights. The Bill of Rights was proposed to assuage Anti-Federalist opposition to Constitutional ratification. Initially, the First Amendment applied only to laws enacted by the Congress, and many of its provisions were interpreted more narrowly than they are today. Beginning with '' Gitlow v. New York'' (1925), the Supreme Court applied the First Amendment to states—a process known as incorporation—through the Due Process Clause of the Fourteenth Amendment. In ''Everson v. Board of Education'' (1947), the Court drew on Thom ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Xyrem
Sodium oxybate, sold under the brand name Xyrem among others, is a medication used to treat two symptoms of narcolepsy: sudden muscle weakness and excessive daytime sleepiness. It is used sometimes in France and Italy as an anesthetic given intravenously; it is also used in Italy to treat alcohol addiction and alcohol withdrawal syndrome. Sodium oxybate is the sodium salt of γ-hydroxybutyric acid (GHB). The clinical trials for narcolepsy were conducted just as abuse of GHB as a club drug and date rape drug became a matter of public concern; in 2000 GHB was made a Schedule I controlled substance, while sodium oxybate, when used under an FDA NDA or IND application, was classified as a Schedule III controlled substance for medicinal use under the Controlled Substances Act, with illicit use subject to Schedule I penalties. Sodium oxybate was approved for use by the US Food and Drug Administration (FDA) to treat symptoms of narcolepsy in 2002, with a strict risk evaluation a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Court Of Appeals For The Second Circuit
The United States Court of Appeals for the Second Circuit (in case citations, 2d Cir.) is one of the thirteen United States Courts of Appeals. Its territory comprises the states of Connecticut, New York and Vermont. The court has appellate jurisdiction over the district courts in the following districts: * District of Connecticut * Eastern District of New York * Northern District of New York * Southern District of New York * Western District of New York * District of Vermont The Second Circuit has its clerk's office and hears oral arguments at the Thurgood Marshall United States Courthouse at 40 Foley Square in Lower Manhattan. Due to renovations at that building, from 2006 until early 2013, the court temporarily relocated to the Daniel Patrick Moynihan United States Courthouse across Pearl Street from Foley Square; certain court offices temporarily relocated to the Woolworth Building at 233 Broadway. Because the Second Circuit includes New York City, it has long b ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Free Speech
Freedom of speech is a principle that supports the freedom of an individual or a community to articulate their opinions and ideas without fear of retaliation, censorship, or legal sanction. The right to freedom of expression has been recognised as a human right in the Universal Declaration of Human Rights and international human rights law by the United Nations. Many countries have constitutional law that protects free speech. Terms like ''free speech'', ''freedom of speech,'' and ''freedom of expression'' are used interchangeably in political discourse. However, in a legal sense, the freedom of expression includes any activity of seeking, receiving, and imparting information or ideas, regardless of the medium used. Article 19 of the UDHR states that "everyone shall have the right to hold opinions without interference" and "everyone shall have the right to freedom of expression; this right shall include freedom to seek, receive, and impart information and ideas of all kind ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 record producer Albums * ''1st'' (album), a 1983 album by Streets * ''1st'' (Rasmus EP), a 1995 EP by The Rasmus, frequently identified as a single * '' 1ST'', a 2021 album by SixTones * ''First'' (Baroness EP), an EP by Baroness * ''First'' (Ferlyn G EP), an EP by Ferlyn G * ''First'' (David Gates album), an album by David Gates * ''First'' (O'Bryan album), an album by O'Bryan * ''First'' (Raymond Lam album), an album by Raymond Lam * ''First'', an album by Denise Ho Songs * "First" (Cold War Kids song), a song by Cold War Kids * "First" (Lindsay Lohan song), a song by Lindsay Lohan * "First", a song by Everglow from '' Last Melody'' * "First", a song by Lauren Daigle * "First", a song by Niki & Gabi * "First", a song by Jonas Bro ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Supreme Court Of The United States
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 tribunals in the United States, federal court cases, and over State court (United States), state court cases that involve a point of Law of the United States, federal law. It also has Original jurisdiction of the Supreme Court of the United States, original jurisdiction over a narrow range of cases, specifically "all Cases affecting Ambassadors, other public Ministers and Consuls, and those in which a State shall be Party." The court holds the power of Judicial review in the United States, judicial review, the ability to invalidate a statute for violating a provision of the Constitution of the United States, Constitution. It is also able to strike down presidential directives for violating either the Constitution or statutory law. However, it may act only within the context of a case in an area of law ove ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Bextra
Valdecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms. It is a selective cyclooxygenase-2 inhibitor. It was patented in 1995. Valdecoxib was manufactured and marketed under the brand name Bextra by G. D. Searle & Company as an anti-inflammatory arthritis drug. It was approved by the United States Food and Drug Administration on November 20, 2001, to treat arthritis and menstrual cramps. and was available by prescription in tablet form until 2005 when the FDA requested that Pfizer withdraw Bextra from the American market. The FDA cited "potential increased risk for serious cardiovascular (CV) adverse events," an "increased risk of serious skin reactions" and the "fact that Bextra has not been shown to offer any unique advantages over the other available NSAIDs." In 2009 Bextra was at the center of the "largest health care fraud settlement and the largest crimina ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutical Marketing
Many countries have measures in place to limit advertising by pharmaceutical companies. Pharmaceutical company spending on marketing generally exceeds that of its research budget. In Canada, $1.7 billion was spent in 2004 to market drugs to physicians; in the United States, $21 billion was spent in 2002. In 2005, money spent on pharmaceutical marketing in the United States was estimated at $29.9 billion with one estimate as high as $57 billion. When the U.S. numbers are broken down, 56% was free samples, 25% was pharmaceutical sales representative "detailing" (promoting drugs directly to) physicians, 12.5% was direct to user advertising, 4% on detailing to hospitals, and 2% on journal ads. There is some evidence that marketing practices can negatively affect both patients and the health care profession. To health care providers Marketing to health-care providers takes three main forms: activity by pharmaceutical sales representatives, provision of drug samples, and sponsoring ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Off-label Use
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 most studies of off-label use focus on prescription drugs. Off-label use is very common and generally legal unless it violates ethical guidelines or safety regulations. The ability to prescribe drugs for uses beyond the officially approved indications is commonly used to good effect by healthcare providers. For example, methotrexate is commonly used off-label because its immunomodulatory effects relieve various disorders. However, off-label use can entail health risks and differences in legal liability. Marketing of pharmaceuticals for off-label use is usually prohibited. Indications and labeling laws An '' indication'' is when a drug is medically appropriate for a given condition; an ''approved indication'' is when a government drug re ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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