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Report Blasts FDA's Drug Safety Oversight

September 23, 2006

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Lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the U.S. Food and Drug Administration's ability to evaluate and address the safety of prescription drugs after they have reached the market, says a new report from the Institute of Medicine.

Noting that resources and therefore efforts to monitor medications' risk-benefit profiles taper off after approval, the committee that wrote the report offered a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.

The recommendations include:

• Labeling requirements and advertising limits for new medications

• Clarified authority and additional enforcement tools for the agency

• Clarification of FDA's role in gathering and communicating additional information on marketed products' risks and benefits

• Mandatory registration of clinical trial results to facilitate public access to drug safety information

• An increased role for FDA's drug safety staff

• A large boost in funding and staffing for the agency

"FDA has an enormous and complex mission -- both to make innovative new drugs available to patients as quickly as possible and to assess the long-term risks and benefits of these products once they are on the market," said Sheila Burke, chair of the committee that wrote the report.

"We found an imbalance in the regulatory attention and resources available before and after approval. Staff and resources devoted to pre-approval functions are substantially greater. Regulatory authority that is well-defined and robust before approval diminishes after a drug is introduced to the market," the report said.

Few high-quality studies are conducted after approval, and the data are generally quite limited. Many of the report's recommendations are intended to bring the strengths of the pre-approval process to the post-approval process, to ensure ongoing attention to medications' risks and benefits for as long as the products are in use.

Labeling Requirements

When new medications, formulations, and delivery systems are introduced to the market, their package labels should carry a symbol for a two-year period alerting patients and health care providers that the products are new and that there may be uncertainties about their risks and benefits, the report says.

It is a widely held misperception that FDA approval of a new drug denotes a guarantee of safety and certainty about its risk-benefit profile. In fact, eliminating all uncertainties prior to approval could cause considerable delay in new products reaching patients in need, the committee noted.

Five years after a product is introduced to the market, FDA should conduct a formal review of all accumulated information about its benefits and risks, it said.

Advertising Moratorium

The committee said it would favor a moratorium on direct-to-consumer advertising during the period when a product carries the symbol denoting newness, but it acknowledged the legal uncertainties surrounding such an imposition.

Such advertising should at least explicitly note that evidence for the product's risks and benefits are less developed than for older drugs, and urge consumers to talk with their physicians about alternatives.

Citing organizational and cultural problems within FDA that hinder its post-approval drug safety activities, the committee recommended a number of ways to bolster the role and expertise of its drug safety staff.

The agency should give its Office of Surveillance and Epidemiology -- formerly known as the Office of Drug Safety -- joint authority with the Office of New Drugs for conducting post-approval regulatory activities. OSE staff members also should be part of the teams that review each application for a new drug approval.

And a six-year term should be established for the FDA commissioner to provide greater stability in leadership for drug safety, the report says.

More Authority

FDA also needs clear authority and appropriate enforcement tools -- such as fines and injunctions -- to ensure that industry complies with label changes and conditions imposed on new products upon or after approval.

FDA now has only limited ability to ask for and negotiate with drug sponsors on these regulatory matters, and its only enforcement option is to withdraw approval.

Strengthening the agency's ability to react to safety problems that arise after approval would help mitigate concerns that timely approval of drugs leads to sacrifices in safety.

Currently, no single organization is charged with responsibility for gathering and analyzing data on medications' risks and benefits after approval, when safety problems may become evident as products become more widely used.

FDA should assume this role, the report says.

The agency needs the expertise and resources to pursue more sophisticated research that can spot changes in the balance of products' risks and benefits. FDA should communicate pertinent findings to the public in a timely manner.

More Public Access

The committee stressed the importance of increasing the public's access to information on medication safety and effectiveness. Current registration of trial data and results is largely voluntary and is not adequately systematic or standardized, the committee concluded.

Congress should require companies to register all phase II through phase IV clinical trials on the federal Web site ClinicalTrials.gov if data from the studies is to be submitted to the agency. Registration should include summaries of all studies' results, regardless of the outcomes.

Conflicts of Interest

The advisory committees that FDA consults as a source of independent insight on questions about new products have attracted criticism because the agency allows individuals with financial ties to the pharmaceutical industry to serve.

Noting that the agency does not impose limits on the number of committee members waived to serve despite financial ties, but also acknowledging that a zero-tolerance policy is unrealistic, the report recommends that a substantial majority -- at least 60 percent -- of advisory committee members be free of significant financial involvement with companies whose interests may be affected by their deliberations.

FDA should issue waivers for the other committee members very sparingly, the committee said.

It is widely acknowledged that FDA is severely underfunded, and implementing the report's recommendations will require additional financial and staff resources. The report calls on Congress to appropriate a substantial increase in both funding and personnel for FDA.

The committee favors appropriations from general revenues, noting that all Americans have an interest in a robust drug safety system and that increasing attention to FDA's post-approval drug safety responsibilities should not occur at the expense of pre-approval activities.

However, if appropriations are not sufficient, Congress should lift most of the restrictions on how the agency can apply fees paid by drug sponsors, which for the most part can now be used only for pre-approval activities.

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