Researcher challenges FDA approval process

A high-profile researcher has issued what is now one of many public challenges to the manner in which the FDA speeds approval of certain drugs.  Researcher Dr. Clifford J. Rosen is concerned, in particular, about shortcuts the FDA is using to approve drugs treating type 2 diabetes, particularly in light of questions about the safety of diabetes drug Avandia. His remarks, which were published in a recent edition of the New England Journal of Medicine, are bringing additional attention to an issue which has recently become much higher-profile.

Rosen is suggesting that approvals should only go through if drug makers can offer proof that a drug saves lives and improves patient health, as measured by such impacts as reductions in stroke, heart attack or mortality rates. Where diabetes drugs are concerned, he suggests, FDA officials should prove that the drugs improve patient quality of life and cut risks for side effects.

Many other observers have assaulted his conclusions, arguing that the new trials he proposes would be very difficult to design. Rosen, however, maintains that the long-term benefits outweigh the short-term costs of designing such studies.

To learn more about the debate:
- read this piece from The Boston Globe

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