The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. As of 2017, 3/4th of the FDA budget is funded by the pharmaceutical companies due to the Prescription Drug User Fee Act.
Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland. It is one of the largest pharmaceutical companies by both market capitalization and sales.
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturing company founded in 1886. Its common stock is a component of the Dow Jones Industrial Average and the company is ranked No. 37 on the 2018 Fortune 500 list of the largest United States corporations by total revenue.
A medication is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management.
Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted.
A generic drug is a pharmaceutical drug that has the same chemical substance as the drug that was originally developed, patented and innovated. Generic drugs are allowed for sale after the expiry of the patent of the original drugs. Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance. The generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in characteristics such as manufacturing process, formulation, excipients, color, taste, and packaging.
A prescription drug is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.
Mark Barr McClellan is the Director of the Robert J Margolis Center for Health Policy and the Margolis Professor of Business, Medicine and Health Policy at Duke University. Formerly, he was a senior fellow and director of the Health Care Innovation and Value Initiative at the Engelberg Center for Health Care Reform at The Brookings Institution, in Washington, D.C. McClellan served as Commissioner of the United States Food and Drug Administration under President George W. Bush from 2002 through 2004, and subsequently as administrator of the Centers for Medicare and Medicaid Services from 2004 through 2006.
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients to cure them, vaccinate them, or alleviate a symptom. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs.
A biopharmaceutical, also known as a biologic(al) medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living cells used in cell therapy. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living cells or tissues. They are isolated from living sources—human, animal, plant, fungal, or microbial.
Peter Rost, M.D. is a former drug marketing executive and is most known for taking public stances critical of the pharmaceutical industry as an "insider" and whistleblower. He sued his last two pharmaceutical employers, Wyeth and Pfizer, the latter of which fired him in 2005. At Wyeth, he uncovered tax evasion practices, and after informing senior company executives, was transferred from Sweden to a post in New Jersey. Rost sued the company, saying that the transfer was a retaliatory demotion, though the company said it was a promotion. Rost settled with Wyeth for an undisclosed amount in 2003. At Pfizer, Rost filed a qui tam suit disclosing off-label marketing of Genotropin at Pharmacia prior to its purchase by Pfizer. The U.S. Department of Justice declined to join in Rost's suit as the marketing violations had already been disclosed to the Department by Pfizer. Rost was eventually fired by Pfizer, and sued for wrongful dismissal, but this lawsuit was summarily dismissed by the court based on evidence that Pfizer had decided to fire Rost prior to discovery of his whistleblowing activities. Since then, Rost has worked outside the pharmaceutical industry, as a public speaker, blogger, writer, and litigation consultant.
Marcia Angell is an American physician, author, and the first woman to serve as editor-in-chief of the New England Journal of Medicine. She is currently a Senior Lecturer in the Department of Global Health and Social Medicine at Harvard Medical School in Boston, Massachusetts.
McNeil Consumer Healthcare is an American medicals products company belonging to the Johnson & Johnson healthcare products group.
Direct-to-consumer (DTC) advertising usually refers to the marketing of pharmaceutical products but also applies to the direct marketing of medical devices, consumer diagnostics and sometimes financial services. Avenues for DTC advertising include TV, print, radio and other mass and social media. This form of advertising is directed toward patients, rather than healthcare professionals. The objective of direct-to-consumer advertising by a pharmaceutical company is to promote a particular medication to the patient directly.
The ethics involved within pharmaceutical sales is built from the organizational ethics, which is a matter of system compliance, accountability and culture. Organizational ethics are used when developing the marketing and sales strategy to both the public and the healthcare profession of the strategy. Organizational ethics are best demonstrated through acts of fairness, compassion, integrity, honor, and responsibility.
A counterfeit medication or a counterfeit drug is a medication or pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. A counterfeit drug may contain inappropriate quantities of active ingredients, or none, may be improperly processed within the body, may contain ingredients that are not on the label, or may be supplied with inaccurate or fake packaging and labeling, as is the case with homeopathic products. Counterfeit drugs are related to pharma fraud. Drug manufacturers and distributors are increasingly investing in countermeasures, such as traceability and authentication technologies, to try to minimise the impact of counterfeit drugs. Antibiotics with insufficient quantities of an active ingredient add to the problem of antibiotic resistance.
Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial is a nonfiction book by investigative journalist Alison Bass, which tells the true story of a court case and the personal drama that surrounded the making of a bestselling drug. It chronicles the lives of two women – a prosecutor and a whistleblower – who exposed deception in the research and marketing of Paxil, an antidepressant prescribed to millions of children and adults. The book shows the connections between pharmaceutical giant GlaxoSmithKline, a top Ivy League research institution, and the government agency designed to protect the public – conflicted relationships that may have compromised the health and safety of vulnerable children.
Selling Sickness: How the World's Biggest Pharmaceutical Companies are Turning us All into Patients is a 2005 book by Ray Moynihan and Alan Cassels about unnecessary health care.
