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Fall 2006 Vol. 6 No. 3

Table of Contents

Speed and Safety

©Lael Henderson/

Restoring Balance to FDA's Drug Approval
and Safety Mission

Could that pill you're taking be hurting you instead of healing you? That question has crossed the minds of millions of Americans in the wake of headline stories about harmful drugs on the market

Even the most rigorously designed and controlled clinical studies may not identify every possible side effect of a new drug before it is approved for use. And many patients take multiple drugs and supplements simultaneously, and often for longer periods than they were administered during studies. Rare or undetected problems may not appear until after a medication is taken by thousands or even millions of patients.

The lingering uncertainties about new drugs make it crucial that the U.S. Food and Drug Administration has the necessary authority, resources, and capabilities to monitor products' risks and benefits as long as they are on the market, says a new report by the Institute of Medicine that assessed the nation's drug safety system. The agency and policymakers need to correct an imbalance that exists between the authority and resources available for FDA's pre-approval activities and its post-approval functions, the report says.

This imbalance is the result of internal factors -- such as cultural and organizational problems within the agency -- as well as external factors, including chronic underfunding, restrictions on how FDA can use fees paid by pharmaceutical firms, and lack of regulatory enforcement tools. The report recommends a host of changes to augment FDA's post-approval safety duties.

For example, Congress should give the agency clearer and more nuanced regulatory options to ensure that drug companies comply with label changes or stipulations placed on products during approval. Currently, FDA's main enforcement tool is the "nuclear option" of withdrawing approval, which the agency hesitates to use because it suspends availability of a product to all patients while potential harmful effects are explored that may involve only a subset of users.

©Photodisc The report also calls on Congress to allocate sufficient funds for the agency to fulfill its post-approval monitoring duties. Funds for pre-approval activities dwarf those for post-market functions, in part because of the fees pharmaceutical firms pay to support new drug reviews, which FDA cannot redirect to other activities. The agency's safety work is so important, the report says, Congress should lift the restrictions on how the agency can apply user fees if it cannot sufficiently boost the agency's funding through general appropriations. FDA's funding also pales next to other health agencies' appropriations. It received $1.5 billion in fiscal year 2006, compared with $5.8 billion appropriated to the Centers for Disease Control and Prevention and the $28.6 billion the National Institutes of Health received. The legislation that created the user fee system is up for reauthorization in 2007.

Information about drugs' risks and benefits should be more readily available to consumers and health care providers. Drug firms should be required to post information on a public Web site about the results of clinical studies on drugs that are submitted to the agency for approval. A moratorium on direct-to-consumer advertising of newly approved products and a special package symbol denoting that a product is new would help address common misperceptions that FDA approval is a guarantee of safety. Five years after approval of a product that is in a new class of drugs, FDA should formally re-evaluate all data on it.

None of the extra resources or efforts on drug safety monitoring and surveillance should come through a de-emphasis of the agency's pre-approval responsibilities. "Getting new drugs to patients who need them as quickly as possible need not be antithetical to drug safety monitoring or vice versa," said committee chair Sheila Burke. "With the appropriate resources and authority, FDA can do both well."
  -- Christine Stencel

The Future of Drug Safety: Promoting and Protecting the Health of the Public. Committee on the Assessment of the U.S. Drug Safety System, Board on Population Health and Public Health Practice, Institute of Medicine (2006, approx. 350 pp.; ISBN 0-309-10304-5; available from the National Academies Press, tel. 1-800-624-6242; $49.00 plus $4.50 shipping for single copies).

The committee was chaired by Sheila Burke, M.P.A., R.N., deputy secretary and chief operating officer, Smithsonian Institution, Washington, D.C. The study was funded by the U.S. Food and Drug Administration, Agency for Healthcare Research and Quality, Centers for Medicare and Medicaid Services, National Institutes of Health, and U.S. Department of Veterans Affairs.

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Copyright 2006 by the National Academy of Sciences