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How the US drug safety system should be changed

intains that the FDA needs an increased ability to regulate drugs after marketing, so that it can require post-marketing studies and labeling changes as a rule, rather than those changes being subject to negotiation between the regulatory agency and industry. It also needs substantially more resources for the postmarketing study of drug safety.

Strom concludes by proposing that an independent, nongovernmental organization is needed for nonregulatory tasks that are not within the mission of the FDA. Since many of these tasks are academic in nature ?for example, performing postmortem examinations in the event of drug disasters or developing new pharmacoepidemiological methods ?he suggests that the Agency for Healthcare Research and Quality (AHRQ)-funded Centers for Education and Research in Therapeutics (CERTS) or the Institute of Medicine (IOM) might play a role.

"A key benefit of this proposed approach for the public would be that drug use immediately after marketing would be reduced to those who truly need the drug, in whom the risk-benefit balance in the face of uncertainty is more favorable," Strom says.


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Source:University of Pennsylvania School of Medicine


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