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Statement from the Center for Drug Evaluation and Research on the IOM Report: Ethical and Scientific Issues in Studying the Safety of Approved Drugs, released May 1, 2012

The U.S. Food and Drug Administration thanks the Institute of Medicine (IOM) for its thoughtful insights and recommendations in its report titled, Ethical and Scientific Issues in Studying the Safety of Approved Drugs. We are encouraged to see that many of the IOM’s recommendations align favorably with current FDA programs and processes, and with our plans for further refinements in how we ensure that marketed drugs are safe and effective for the American public.

Many of themes raised by IOM parallel current Agency activities related to postmarketing safety of drugs as described FDA’s April 21 report on drug safety, which outlined a wide range of actions FDA has taken in recent years to enhance its postmarket safety programs. Importantly, the FDA report made clear that FDA monitors a drug’s safety throughout its lifecycle, and considers the oversight of drugs once they reach the market of equal importance to the premarket review of new drug and biologics applications.

One of the major recommendations made by the IOM is for FDA “to develop and maintain for each new drug and for already FDA-approved drugs for which questions about the benefit-risk profile are raised, a publicly available and understandable Benefit and Risk Assessment and Management Plan (BRAMP).” We support the general concept of enabling the public to be able to clearly monitor relevant safety issues for all drugs.  However, we believe it would be very challenging to implement this recommendation within our current resources without seriously compromising other critical regulatory activities.

FDA is currently engaged in developing a systematic process for assessing and communicating new information about a drug after it is marketed. This will include a qualitative framework for drug benefit-risk assessment that uses a multi-disciplinary team approach for making safety decisions and employs enhanced methods for tracking and prioritizing potential drug safety issues. The 2012 reauthorization of the Prescription Drug User Fee Act, now before Congress, would substantially expand this effort.

FDA supports the IOM recommendation to continue our efforts to enhance transparency through full disclosure of information. Although we support the concept of sharing as much information with the public as is practical and possible, some of the recommended changes in disclosure policies would require changes to existing laws and regulations.

The IOM report specifies many additional recommendations with regard to FDA decision-making and authorities, as well as ethical issues that arise during the conduct of postmarketing research. We are now in the process of fully analyzing the report to determine how to implement changes that will have the largest positive impact on public health.


 In early 2010, the FDA asked the IOM for advice on when to require a postmarket epidemiologic study or clinical trial to evaluate a possible safety risk, and how to ethically construct and conduct such studies (e.g., what patient informed consent procedures should be applied).

The IOM’s Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs found that that the ethical issues are very challenging and complex, and that there is no general “algorithm” that can be used by FDA to decide when to require a postmarket epidemiologic study or clinical trial since each case depends on the unique circumstances around the drug and the nature of the potential risks.  In its report, the Committee described more generally the circumstances that might trigger heightened concern about a drug and the types of epidemiologic studies or clinical trials that might be done. 

The Committee also provided a broad set of recommendations for how FDA might approach postmarket drug safety and how the Agency’s decision-making processes with regard to a drug’s benefits and risks should be publicized.

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