Healthy Skepticism Library item: 12566

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

A Wilde-Mathews, Winslow B.
FDA Procedures Draw Scrutiny
The Wall Street Journal 2008 Jan 25
http://online.wsj.com/article/SB120122452254515507.html?mod=googlenews_wsj

Abstract:

Controversies about cholesterol drug Vytorin and diabetes drug Avandia are reigniting debate over what evidence the Food and Drug Administration requires to approve drugs — and may generate pressure on the agency to raise its bar.

The FDA’s system for approving drugs has been criticized as scrutiny grows about Vytorin, marketed by Schering-Plough Corp. and Merck & Co., in the wake of a study that raised questions about whether the widely advertised blockbuster worked better than a cheaper generic.

Yesterday, Democratic Reps. John Dingell and Bart Stupak, both of Michigan and leaders of the House Energy and Commerce Committee, sent …