Peter Rheinstein

Last updated
Peter Howard Rheinstein
Prheinstein.jpg
Rheinstein in 1995
Born (1943-09-07) September 7, 1943 (age 81)
Cleveland, Ohio, U.S.
NationalityAmerican
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 forregulation of prescription drug promotion
Spouse
Miriam Rheinstein
(m. 1969)
ChildrenJason Rheinstein
AwardsCommendable 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) from 1974 to 1999.

Contents

Education

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]

Food and Drug Administration

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] and director medicine staff Office Health Affairs (1990-99). [8] [9] While at the 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 on December 11, 1985. [16] Stone Phillips interviewed Rheinstein about drug labeling on Dateline NBC on March 31, 1992. [17]

Later career

From 1999 to 2004, Rheinstein was senior vice president for medical and clinical affairs at Cell Works, Inc., in 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 past president of the Academy of Medicine of Washington, DC. [23] Sarah Gonzalez interviewed Rheinstein for Planet Money, This Is Your Brain on Drug Ads, on September 8, 2021. [24]

Publications

Related Research Articles

<span class="mw-page-title-main">Food and Drug Administration</span> United States federal agency

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.

<span class="mw-page-title-main">Emergency contraception</span> Birth control measures taken after sexual intercourse

Emergency contraception (EC) is a birth control measure, used after sexual intercourse to prevent pregnancy.

<span class="mw-page-title-main">Medication</span> Substance used to diagnose, cure, treat, or prevent disease

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.

<span class="mw-page-title-main">Mifepristone</span> Medication

Mifepristone, also known by its developmental code name RU-486, is a medication typically used in combination with misoprostol to bring about a medical abortion during pregnancy and manage early miscarriage. This combination is 97% effective during the first 63 days of pregnancy. It is also effective in the second trimester of pregnancy. It is taken by mouth.

<span class="mw-page-title-main">American Medical Association</span> Organization

The American Medical Association (AMA) is an American professional association and lobbying group of physicians and medical students. Founded in 1847, it is headquartered in Chicago, Illinois. Membership was 271,660 in 2022.

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.

<span class="mw-page-title-main">Tadalafil</span> Medication used to treat erectile dysfunction

Tadalafil, sold under the brand name Promel, Cialis among others, is a medication used to treat erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension. It is taken by mouth. Onset is typically within half an hour and the duration is up to 36 hours.

<span class="mw-page-title-main">Orlistat</span> Drug designed to treat obesity

Orlistat, sold under the brand name Xenical among others, is a medication used to treat obesity. Its primary function is preventing the absorption of fats from the human diet by acting as a lipase inhibitor, thereby reducing caloric intake. It is intended for use in conjunction with a healthcare provider-supervised reduced-calorie diet.

<span class="mw-page-title-main">Loratadine</span> Antihistamine medication

Loratadine, sold under the brand name Claritin among others, is a medication used to treat allergies. This includes allergic rhinitis and hives. It is also available in drug combinations such as loratadine/pseudoephedrine, in which it is combined with pseudoephedrine, a nasal decongestant. It is taken orally.

<span class="mw-page-title-main">Mark McClellan</span> American health economist (born 1963)

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.

<span class="mw-page-title-main">Judy Woodruff</span> American broadcast journalist

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).

Sominex is the trademarked name for several over the counter sleep aids.

<span class="mw-page-title-main">Emtricitabine/tenofovir</span> Drug combination for HIV/AIDS prophylaxis and treatment

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.

<span class="mw-page-title-main">Raltegravir</span> Chemical compound

Raltegravir, sold under the brand name Isentress, is an antiretroviral medication used, together with other medication, to treat HIV/AIDS. It may also be used, as part of post exposure prophylaxis, to prevent HIV infection following potential exposure. It 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.

<span class="mw-page-title-main">Sidney M. Wolfe</span> American physician (1937–2024)

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.

<span class="mw-page-title-main">Eliglustat</span> Chemical compound

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.

<span class="mw-page-title-main">Nirmatrelvir/ritonavir</span> Antiviral combination medication

Nirmatrelvir/ritonavir, sold under the brand name Paxlovid, is a co-packaged medication used as a treatment for COVID‑19. It contains the antiviral medications nirmatrelvir and ritonavir and was developed by Pfizer. Nirmatrelvir inhibits SARS-CoV-2 main protease, while ritonavir is a strong CYP3A inhibitor, slowing down nirmatrelvir metabolism and therefore boosting its effect. It is taken by mouth.

<span class="mw-page-title-main">Lifetime Medical Television</span> Television programming for doctors

Lifetime Medical Television (LMT) was a television service featuring programming directed at doctors. It aired on the Lifetime cable channel in the United States from 1983 to 1993. Co-owned with the network by Hearst-ABC/Viacom Entertainment Services (HAVES), LMT was the longest-running specialist program service for doctors at its closure. Some of its programs were sponsored by a core group of pharmaceutical companies, who also aired advertisements for specific drugs aimed at physicians.

References

  1. American College of Legal Medicine Gold Medal, recipients Archived 2013-08-18 at the Wayback Machine
  2. Steven G. Krantz. Mathematical Apocrypha: Stories and Anecdotes of Mathematicians and the Mathematical. The Mathematical Association of America (July 15, 2002) pp187-188
  3. Are these mathematical tales apocryphal? reddit.com
  4. VICTOR COHN. FALSE ADS CHARGED U. S. Impounds Millions of Birth Control Pills. Los Angeles Times. Jan 1, 1975, p A1
  5. F.D.A. Seized 25 Million Birth Control Pills in Dispute Over Advertisements. NY Times Jan. 1, 1975
  6. SURGEONS' MARKERS CITED FOR INFECTIONS. Philadelphia Inquirer. July 23, 1987
  7. BARRY MEIER. Diet-Pill Death Raises Questions On F.D.A. Role. New York Times August 4, 1990
  8. WILL PEOPLE COUGH UP $50 FOR $5 DRUG? ORGANIDIN'S MAKERS REPLACED AN INGREDIENT WITH ONE THAT'S AVAILABLE OVER THE COUNTER. THEY KEPT THE PRICE. Philadelphia Inquirer. Oct 14, 1994 A2.
  9. Hospitals' Fatal Mistakes Repeated Elsewhere. Beaver County Times. Oct 24, 1993
  10. Peter Rheinstein. The Wrong Way to Control Drug Prices. Washington Times April 19, 2016
  11. Dylan Scott. The untold story of TV's first prescription drug ad. THE WEEK December 28, 2015
  12. Lazar EJ, Banks D, Graham C, Adams D, Rheinstein PH, Gross M, Witt AM.Drug company sponsorship of education: the response to the FDA draft concept paper. JAMA. 1992 Jul 1;268(1):53-4 PMID   1608109
  13. Peck CC, Rheinstein PH. FDA regulation of prescription drug advertising. JAMA. 1990 Nov 14;264(18):2424-5 PMID   2232001
  14. Rheinstein PH. Regulatory status of pancreatic enzyme preparations. JAMA. 1990 May 9;263(18):2491-2 PMID   2329638
  15. Faich GA, Morrison J, Dutra EV Jr, Hare DB, Rheinstein PH. Reassurance about generic drugs. N Engl J Med. 1987 Jun 4;316(23):1473-5 PMID   3574426
  16. Judy Woodruff interviews Peter Rheinstein about generic drug safety on the McNeil-Lehrer NewsHour, 11 Dec 1985.
  17. Stone Phillips interviews Peter Rheinstein about drug labeling, Dateline NBC, March 31, 1992
  18. Tom Ramstack. Germ research gets urgent; Bioterrorism fuels interest, funding of scientific projects. Washington Times. June 9, 2003 page 1.
  19. Academy of Physicians in Clinical Research - AMA Delegate's Report 2013
  20. Peter Rheinstein – Lawyer – Justia
  21. Peter Rheinstein's Biography from Who's Who in America (April 2013)
  22. MedData Foundation official website
  23. Academy of Medicine of Washington, DC past officers
  24. Sarah Gonzalez interviews Peter Rheinstein for Planet Money, This is Your Brain on Drug Ads, 8 Sept 2021
  25. Peter Rheinstein's recent AMA House of Delegate Articles (pages 7 and 8, May 2017)
  26. Peter Rheinstein's recent AMA House of Delegate Articles, November 2015
  27. Peter Rheinstein's recent AMA House of Delegate Articles, June 2015
  28. Peter Rheinstein AMA HOUSE OF DELEGATES APCR DELEGATE’S REPORT JUNE 7, 2020