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Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation. Challenges for the FDA: The Future of Drug Safety, Workshop Summary. Washington (DC): National Academies Press (US); 2007.

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Challenges for the FDA: The Future of Drug Safety, Workshop Summary.

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1Introduction

Mission Statement of the U.S. Food and Drug Administration

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

SOURCE: FDA, 2007a.

The FDA regulates products representing roughly 25 percent of all consumer spending in the United States (Coalition for a Stronger FDA, 2007). Since 1992, when the Prescription Drug User Fee Act (PDUFA) was enacted, federal funding for the agency has diminished. Currently the FDA’s Center for Drug Evaluation and Research (CDER) relies on the fees that it receives from the industry it regulates to fund its essential programs. At the same time, the issue of prescription drug safety has received widespread public and congressional scrutiny as a result of the highly publicized recall of the arthritis drug Vioxx because of its link to serious cardiovascular events, and more recently the increased risk of suicidal ideation among children being treated for depression with selective serotonin reuptake inhibitors (SSRIs). There is growing public concern about the ability of the current drug safety system to prevent future Vioxx-like events.

In light of this increased scrutiny, the FDA commissioned the Institute of Medicine (IOM) to convene an ad hoc committee of experts to conduct an independent assessment of the current U.S. drug safety system. A consensus report with recommendations for the system’s improvement—The Future of Drug Safety: Promoting and Protecting the Health of the Public (hereafter referred to as the IOM report)—was released on September 22, 2006. The IOM committee that produced the report identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre- and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing (an underlying issue being the use of modern information technology and informatics, and the human expertise and systems that enable their use); and (4) unclear regulatory authority and insufficiently flexible regulatory tools (IOM, 2007a).

Since the IOM report was issued, the FDA has taken a number of steps toward implementing the improvements recommended by the report (see Box 1-1). Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments from the agency. Without providing a full analysis of the costs associated with its recommendations, the IOM report left open a number of questions about the ability of the agency to achieve the envisioned improvements. Attempting to implement the report’s 25 recommendations without a substantial funding increase could further strain the FDA’s resources, thereby making it more difficult to identify safety problems associated with new drugs, to monitor routinely submitted safety data, and to relay the resulting information to the public.

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BOX 1-1

Highlights of the FDA’s Response to the IOM Report. Strengthening the Science Improving how the agency assesses risk is a central component of the FDA’s efforts to improve pharmaceutical drug safety. The agency is operating in this area (more...)

To address this gap, the IOM’s Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007 to consider the types and magnitude of resources needed to implement some of the most resource-intensive recommendations of the IOM report. The symposium’s presentations and discussions were in most cases framed by selected recommendations from the report, and are summarized here in seven key areas:

  • addressing the FDA’s resource challenges;
  • strengthening the scientific base of the agency;
  • integrating pre- and postmarket review;
  • enhancing postmarket safety monitoring;
  • conducting confirmatory drug safety and efficacy studies;
  • enhancing the value of clinical trial registration; and
  • enhancing the FDA’s postmarket regulation and enforcement.

The presentations and discussions included the types and magnitude of resources required in these areas. A session at the close of the symposium looked to the future, exploring prerequisites for revitalizing the U.S. drug safety system and the future of drug safety regulation. It should be noted that, while the IOM report suggested some organizational and cultural changes at the FDA, those recommendations were not a focus of the discussions during the symposium. Additionally, participants did not deliberate upon whether the FDA in its current form is properly configured to lead the efforts that were discussed.

Copyright © 2007, National Academy of Sciences.
Bookshelf ID: NBK52933
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