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  Latest News  
  November 9, 2004  


  Reviewing Drug Safety
FDA will audit its monitoring of drugs on the market


The Food & Drug Administration has announced a major review of its system for monitoring the safety of drugs already on the market. FDA will sponsor an Institute of Medicine study of the agency’s safety monitoring procedures, and it will set up a formal program to make sure that the views of dissenting agency scientists are heard.

The announcement comes in the wake of criticism over the agency’s handling of warnings about the painkiller Vioxx and the use of certain antidepressants.

In related developments, FDA will conduct a search for a new director of its Office of Drug Safety, a position that has been vacant for almost a year. And FDA’s Center for Drug Evaluation & Research will conduct workshops and host advisory committee meetings to discuss drug safety and risk management issues, including risks concerning drugs that are already on the market.

“I am satisfied that these additional activities will strengthen the agency’s program to greater ensure the safety of medical products that are making a major contribution to the health and quality of life of millions of Americans,” Acting FDA Commissioner Lester M. Crawford Jr. said in a statement.

“It’s important that people recognize that all medicines have inherent risks. Pharmacists, patients, and their physicians should work together to determine if the benefits of a particular medicine outweigh the risks,” says Court Rosen, spokesman for the Pharmaceutical Research & Manufacturers of America.

  Chemical & Engineering News
ISSN 0009-2347
Copyright © 2004

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Merck Pulls The Plug On Painkiller Vioxx
[C&EN, Oct. 4, 2004]
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[C&EN, Oct. 25, 2004]

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