When is a drug too risky to stay on the market?


July 1, 2010

Associated Press (AP)

In the past few years, the arthritis pill Vioxx has withdrawn from the market -- yet menopause hormones were not - despite the fact that both were tied to heart risks. A multiple sclerosis medicine was pulled from the market, but then later permitted back on. Then the question of drug safety arose again this week amid protests for the diabetes drug Avandia to be pulled from the market. The Associated Press article reports the Food and Drug Administration surprisingly 'has no firm rules for deciding such cases -- just a murky guideline of 'when the risks exceed the benefits.'" To help clarify things, the FDA has asked an outside organization, the Institute of Medicine, to give advice. They are expected to give a report before the July 13-14 hearing on Avandia. According to the article, the "FDA can order a drug off the market, but that can be challenged in court. Usually, a company voluntarily withdraws the medicine at the FDA's request. Many things influence whether such a request is made," said Brian Strom, MD, chair and professor of Biostatistics and Epidemiology, director of the Center for Clinical Epidemiology & Biostatistics and vice dean for Institutional Affairs. In the article, Strom is quoted as a drug safety expert and longtime FDA drug safety adviser. Read More