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European Medicines Agency (EMA) announced that marketing of rosiglitazone was suspended, but formal approval had not been revoked.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.

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John E. Calfee is a resident scholar at AEI.

Photo Credit: iStockphoto/Sharon Dominick

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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.

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