Magazine article Clinical Psychiatry News

FDA Plans to Strengthen Drug Safety Program

Magazine article Clinical Psychiatry News

FDA Plans to Strengthen Drug Safety Program

Article excerpt

In the wake of the withdrawal of rofecoxib and the addition of a black box warning for antidepressants, the Food and Drug Administration has announced a plan aimed at strengthening its safety program for drugs.

A main component of the plan is an FDA-sponsored study by the Institute of Medicine that will evaluate the current drug safety system, with emphasis on the postmarketing phase. The IOM study will assess what additional steps could be taken to learn more about the adverse effects of drugs once they are on the market.

The FDA also plans to create a system to adjudicate differences of professional opinion within its Center for Drug Evaluation and Research (CDER) concerning a particular drug, a situation that was widely reported to be an issue with the rofecoxib and antidepressant safety reviews. Workshops and advisory committee meetings where drug safety and risk management issues will be discussed are also planned for next year, including an advisory panel meeting in February on the safety of the cyclooxygenase-2 (COX-2) inhibitors.

These efforts are aimed at "keeping the agency on the cutting edge of public health protection, with regard to the risks of pharmaceutical products," and to "enhance the confidence" of Americans in the safety of the drugs they are prescribed, Steven Galson, M.D., acting CDER director, Rockville, Md., said during a telephone press briefing held to announce the FDA's plans.

Postmarketing drug safety has become a prominent issue. …

Search by... Author
Show... All Results Primary Sources Peer-reviewed

Oops!

An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.