Peter Howard Rheinstein | |
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Born | |
Nationality | American |
Education | Michigan State University (BA, MS) Johns Hopkins University (MD) University of Maryland School of Law (JD) |
Occupation(s) | healthcare company executive, physician, lawyer |
Known for | regulation of prescription drug promotion |
Spouse | Miriam Rheinstein (m. 1969) |
Children | Jason Rheinstein |
Awards | Commendable Service award, Food and Drug Administration, 1981, Group award of merit, 1983, 1988, Group Commendable Service award, 1989, 1992—93, 1995, 1999, Commr.'s Special citation, 1993, American College of Legal Medicine Gold Medal (2003) [1] |
Peter Howard Rheinstein (born September 7, 1943) is an American physician, lawyer, author, and administrator (both private and governmental). He was an official of the Food and Drug Administration (FDA) 1974-1999.
Rheinstein, a General Motors Scholar, received a B.A. with high honors from Michigan State University in 1963, an M.S. in mathematics from Michigan State University in 1964, an M.D. from Johns Hopkins University in 1967, and a J.D. from the University of Maryland School of Law in 1973. At Michigan State University Rheinstein was noted for his facility in mathematics. [2] [3]
Rheinstein was director of the Drug Advertising and Labeling Division, Food and Drug Administration, Rockville, 1974-1982; [4] [5] he was acting deputy director Office of Drugs, 1982–83, acting director Office of Drugs; 1983–84, director Office of Drug Standards, 1984–90, [6] [7] director medicine staff Office Health Affairs, 1990-99. [8] [9] While at FDA Rheinstein developed precedents for Food and Drug Administration regulation of prescription drug promotion, initiated FDA’s first patient medication information program; implemented the Drug Price Competition and Patent Term Restoration Act of 1984, and authored medication goals for Healthy People 2000 and 2010. [10] [11] [12] [13] [14] [15] Judy Woodruff interviewed Rheinstein about generic drug safety on the McNeil-Lehrer NewsHour, 11 Dec 1985. [16] Stone Phillips interviewed Rheinstein about drug labeling on Dateline NBC, March 31, 1992. [17]
From 1999 – 2004, Rheinstein was senior vice president for medical and clinical affairs, Cell Works, Inc., Baltimore. Among other projects, Cell Works wanted to develop a blood test for anthrax, similar to a system for cancer cells it produced. "It's something that companies like ours can incorporate into our diagnostic technology," Rheinstein told the Washington Times. Biodefense projects "create new technologies, the spin-offs of which can be commercialized into some pretty good things." [18] In 2000 Rheinstein became president of Severn Health Solutions in Severna Park, Maryland. In 2010 Rheinstein was named president of the Academy of Physicians in Clinical Research [19] and in 2011 was named chairman of the American Board of Legal Medicine. Rheinstein was named chairman of the United States Adopted Names Council in 2012. Rheinstein is a member of Phi Kappa Phi, [20] and vice-president of the Intercultural Friends Foundation. [21] Rheinstein is publisher of Discovery Medicine and chairman of MedData Foundation. [22] He is president-elect of the Academy of Medicine of Washington, DC. [23] Sarah Gonzalez interviewed Rheinstein for Planet Money, This is Your Brain on Drug Ads, 8 Sept 2021. [24]
The United States Food and Drug Administration 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 safety, tobacco products, caffeine 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.
Emergency contraception (EC) is a birth control measure, used after sexual intercourse to prevent pregnancy.
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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 prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.
Prescription drug list prices in the United States continually are among the highest in the world. The high cost of prescription drugs became a major topic of discussion in the 21st century, leading up to the American health care reform debate of 2009, and received renewed attention in 2015. One major reason for high prescription drug prices in the United States relative to other countries is the inability of government-granted monopolies in the American health care sector to use their bargaining power to negotiate lower prices, and the American payer ends up subsidizing the world's R&D spending on drugs.
A prescription drug is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. 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.
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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.
Oxycodone/paracetamol, sold under the brand name Percocet among others, is a fixed-dose combination of the opioid oxycodone with paracetamol (acetaminophen), used to treat moderate to severe pain.
Pharmaceutical marketing is a branch of marketing science and practice focused on the communication, differential positioning and commercialization of pharmaceutical products, like specialist drugs, biotech drugs and over-the-counter drugs. By extension, this definition is sometimes also used for marketing practices applied to nutraceuticals and medical devices.
Judy Carline Woodruff is an American broadcast journalist who has worked in local, network, cable, and public television news since 1970. She was the anchor and managing editor of the PBS NewsHour through the end of 2022. Woodruff has covered every presidential election and convention since 1976. She has interviewed several heads of state and moderated U.S. presidential debates.
A United States Adopted Name (USAN) is a unique nonproprietary name assigned to a medication marketed in the United States. Each name is assigned by the USAN Council, which is co-sponsored by the American Medical Association (AMA), the United States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA).
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Emtricitabine/tenofovir, sold under the brand name Truvada among others, is a fixed-dose combination antiretroviral medication used to treat and prevent HIV/AIDS. It contains the antiretroviral medications emtricitabine and tenofovir disoproxil. For treatment, it must be used in combination with other antiretroviral medications. For prevention before exposure, in those who are at high risk, it is recommended along with safer sex practices. It does not cure HIV/AIDS. Emtricitabine/tenofovir is taken by mouth.
Direct-to-consumer advertising (DTCA) refers to the marketing and advertising of pharmaceutical products directly to consumers as patients, as opposed to specifically targeting health professionals. The term is synonymous primarily with the advertising of prescription medicines via mass media platforms—most commonly on television and in magazines, but also via online platforms.
Sidney Manuel Wolfe was an American physician and the co-founder and director of Public Citizen's Health Research Group, a consumer and health advocacy lobbying organization. He publicly crusaded against many pharmaceutical drugs, which he believed to be a danger to public health.
Eliglustat, sold under the brand name Cerdelga, is a medication used for the treatment of Gaucher's disease. It was discovered at the University of Michigan, developed by Genzyme Corp, and was approved by the FDA in August 2014. Commonly used as the tartrate salt, the compound is believed to work by inhibition of glucosylceramide synthase. According to an article in Journal of the American Medical Association the oral substrate reduction therapy resulted in "significant improvements in spleen volume, hemoglobin level, liver volume, and platelet count" in untreated adults with Gaucher disease Type 1.
There is an ongoing opioid epidemic in the United States, originating out of both medical prescriptions and illegal sources. The epidemic began in the United States in the late 1990s, according to the Centers for Disease Control and Prevention (CDC), when opioids were increasingly prescribed for pain management, resulting in a rise in overall opioid use throughout subsequent years.
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