Drug Litigation Newsroom

FDA Aims to Boost Safety of Approved Drugs

The U.S. Food and Drug Administration, facing a barrage of criticism from both within and outside the agency, announced plans Friday to improve the safety of drugs after they have been approved.

The FDA has been stung by rebukes that it didn't do enough to prevent problems that arose with drugs after they hit the market, such as fen-phen and, most recently, Vioxx and antidepressants for children.

The agency's acting commissioner, Dr. Lester Crawford, announced these steps to improve drug safety:

Establish an Institute of Medicine committee to determine the effectiveness of the drug safety program in the United States, including the FDA's role.

Start a program that would allow differing opinions to be taken into account in the review process. Many scientists have complained that their objections to some drugs weren't heard, and this would allow a "free and open discussion of scientific issues."
Hire a director of drug safety, a position now vacant.

And conduct more meetings of advisory committees on drug safety.
"Experience has shown that the full magnitude of some potential risks have not always emerged during the mandatory clinical trials conducted before approval," Crawford acknowledged in a statement