Avandia and FDA Regulation

In Sept. 23, 2010, the Food and Drug Administration (FDA) announced that rosiglitazone (Avandia), a diabetes drug manufactured by GlaxoSmithKline (GSK), would be the subject of a stringent Risk Evaluation and Management Strategy (REMS) that will undoubtedly greatly reduce its use. At the same time, the European Medicines Agency (EMA) announced that marketing of rosiglitazone was suspended, but formal approval had not been revoked. FDA also halted the Thiazolidinedione Intervention with Vitamin D (TIDE) trial, a head-to-head cardiovascular safety comparison of rosiglitazone and a similar drug, pioglitazone, which GSK had undertaken at FDA's request. FDA halted the trial because of doubts about whether it would yield useful results or was even feasible in the face of safety concerns about rosiglitazone. In addition, GSK agreed to cease all promotional activities for rosiglitazone.

These coordinated announcements were the culmination of more than three years of sometimes impassioned debate over the safety of rosiglitazone. This episode is not over. FDA has commissioned an independent assessment of an important, but flawed, safety trial of rosiglitazone (the RECORD trial discussed below). If the published RECORD results hold up, rosiglitazone could yet be freed from the strict REMS imposed in the United States and could even be restored to the E.U. market. In any case, this episode is revealing much about the continuing evolution of FDA drug regulation.

Read the full text as an Adobe Acrobat PDF.

John E. Calfee is a resident scholar at AEI.

Photo Credit: iStockphoto/Sharon Dominick

Also Visit
AEIdeas Blog The American Magazine
About the Author

 

John E.
Calfee
  • Economist John E. Calfee (1941-2011) studied the pharmaceutical industry and the Food and Drug Administration (FDA), along with the economics of tobacco, tort liability, and patents. He previously worked at the Federal Trade Commission's Bureau of Economics. He had also taught marketing and consumer behavior at the business schools of the University of Maryland at College Park and Boston University. While Mr. Calfee's writings are mostly on pharmaceutical markets and FDA regulation, his academic articles and opinion pieces covered a variety of topics, from patent law and tort liability to advertising and consumer information. His books include Prices, Markets, and the Pharmaceutical Revolution (AEI Press, 2000) and Biotechnology and the Patent System (AEI Press, 2007). Mr. Calfee wrote regularly for AEI's Health Policy Outlook series. He testified before Congress and federal agencies on various topics, including alcohol advertising; biodefense vaccine research; international drug prices; and FDA oversight of drug safety.

What's new on AEI

AEI Election Watch 2014: What will happen and why it matters
image A nation divided by marriage
image Teaching reform
image Socialist party pushing $20 minimum wage defends $13-an-hour job listing
AEI on Facebook
Events Calendar
  • 27
    MON
  • 28
    TUE
  • 29
    WED
  • 30
    THU
  • 31
    FRI
Monday, October 27, 2014 | 10:00 a.m. – 11:30 a.m.
State income taxes and the Supreme Court: Maryland Comptroller v. Wynne

Please join AEI for a panel discussion exploring these and other questions about this crucial case.

Tuesday, October 28, 2014 | 9:30 a.m. – 12:15 p.m.
For richer, for poorer: How family structures economic success in America

Join Lerman, Wilcox, and a group of distinguished scholars and commentators for the release of Lerman and Wilcox’s report, which examines the relationships among and policy implications of marriage, family structure, and economic success in America.

Tuesday, October 28, 2014 | 5:30 p.m. – 7:00 p.m.
The 7 deadly virtues: 18 conservative writers on why the virtuous life is funny as hell

Please join AEI for a book forum moderated by Last and featuring five of these leading conservative voices. By the time the forum is over, attendees may be on their way to discovering an entirely different — and better — moral universe.

Thursday, October 30, 2014 | 2:00 p.m. – 3:00 p.m.
A nuclear deal with Iran? Weighing the possibilities

Join us, as experts discuss their predictions for whether the United States will strike a nuclear deal with Iran ahead of the November 24 deadline, and the repercussions of the possible outcomes.

Thursday, October 30, 2014 | 5:00 p.m. – 6:15 p.m.
The forgotten depression — 1921: The crash that cured itself

Please join Author James Grant and AEI senior economists for a discussion about Grant's book, "The Forgotten Depression: 1921: The Crash That Cured Itself" (Simon & Schuster, 2014).

No events scheduled this day.
No events scheduled this day.
No events scheduled this day.
No events scheduled today.
No events scheduled this day.