FDA and Lifestyle Drugs — The Next Chapter in the Story

Posted by gcuppan

July 21, 2010

For those who may have missed the news from last week, Vivus Pharmaceuticals missed big time with Qnexa. Their FDA Endocrinologic and Metabolic Drugs advisory committee voted against recommending the anti-obesity drug for approval, basing their decision primarily on the absence of long-term safety data. The committee vote was 10 to 6 against approval. A comment made by Dr. Lamont G. Weide, MD, PhD, of the University of Missouri, Kansas City is a telling marker of how attitude is changing in the assessment of drugs seen as lifestyle treatments. Weide said that he was tired of having to take drugs off the market after they have been in use for a few years because of failing to identify problems. “That really is some of what has given the FDA a bad reputation outside in the public. We have a responsibility to protect the public at large.”

The drug development graveyard is filling up with much ballyhooed prescription weight loss drugs.

Communication of Science

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