Lack of clear regulatory authority and chronic underfunding at the Food and Drug Administration are among the problems affecting drug safety work for products already on the market, a Sept. 22 report from the Ins ute of Medicine said.
In particular, IOM said FDA's current organizational culture at its Center for Drug Evaluation and Research is "in crisis" and the center is underfunded.
The IOM study, The Future of Drug Safety: Promoting and Protecting the Health of the Public, is part of a drug safety initiative launched by FDA in 2005, and could have huge implications for future drug safety legislation and lead Congress to pass new drug safety reforms.
FDA official Paul J. Seligman told a conference in June that he anticipated the IOM report "will have a profound influence on future drug safety laws" (4 PLIR 748, 6/30/06 a0b2y4q5m3 ).
The FDA drug safety initiative was designed to make timely drug safety information available to the public and health care professionals and to make the agency's drug review and monitoring process more transparent.
Among other things, the IOM report concludes that there is a perception that FDA is beholden to the drug industry and that the agency panels are rife with conflicts of interest. In addition, the report says, FDA is underfunded and is working under weak regulatory authorities, which are particularly ambiguous on the enforcement front.
The report makes approximately 25 recommendations including: a six-year term for FDA commissioners; clarified authority and additional enforcement tools for the agency; labeling requirements and advertising limits for new medications; compulsory registration of clinical trial results to ease public access to drug safety information; substantial increases in funding and resources for the agency; and clarification of FDA's role in gathering and communicating additional information on marketed products' risks and benefits.
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