By Laura Gilcrest, CBS MarketWatch
Last Update: 11:58 AM ET Nov. 5, 2004
WASHINGTON (CBS.MW)-- The U.S Food and Drug Administration said on Friday that it has asked the Institute of Medicine to review how FDA monitors drugs after they hit the market.
IOM, an arm of the National Academies of Science, will assess what steps can be taken to learn more about drugs' side effects once they're being prescribed to patients, then give advice for enhancing public confidence in drugs' safety and effectiveness.
FDA's request for the IOM study is part of a broader plan to shore up the nation's post-market drug monitoring system in the wake of the recent market withdrawal of Merck's (MRK: news, chart, profile) arthritis drug Vioxx.
FDA reviews a drug's clinical data on safety and effectiveness to decide whether to grant market approval, but continues to scrutinize the drug's safety once it's on the market.
The agency gets post-market data via additional clinal studies and through adverse events reports submitted through FDA's MedWatch program.
But managing a drug's risks and benefits is no easy task, said Acting FDA Commissioner Lester Crawford. "FDA is determined to meet this challenge by employing cutting edge science, transparent policy, and sound decisions based on the advice of the best experts in and out of the agency," he said in a statement issued on Friday.
Crawford said FDA would also set up a program to resolve conflicting opinions among its drug reviewers about a particular drug's approvability.
In most cases, FDA's medical reviews reach agreement, he said, adding that, "Sometimes, however, a consensus decision cannot be reached and an employee may feel that his or her opinion was not adequately considered."
Under the plan, an ad hoc panel not directly involved in internal disputes will have 30 days to review relevant data and recommend a course of action.
FDA said it would also work to fill the vacant position of director of its Office of Drug Safety, hold workshops and advisory panel meetings on drug risk management issues, and release by year's end, three final guides to help drug firms manage product risks.
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