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Report Calls for Sweeping Changes At the FDA

By Janice G. Inman
October 30, 2006

In September, the Institute of Medicine of the National Academy of Sciences, a congressionally created entity dedicated to the study of policy matters pertaining to the public health, issued the results of the study of federal drug safety policy commissioned by the Food and Drug Administration (FDA). The resulting report, titled 'The Future of Drug Safety, Promoting and Protecting the Health of the Public' and published in the Archives of Internal Medicine, has been widely anticipated in light of recent publicity surrounding Vioxx' and other drugs that, subsequent to FDA-approval, proved more dangerous than thought. The authors' goals in carrying out the study included gaining a better understanding of the FDA's current role and the roles of other actors in the process and assessing how changes in these organizations and systems could help promote increased drug safety and better public confidence. The committee's bottom line assessment was that major changes in the way the FDA is organized and funded are needed.

Some Organizational Changes

The Center for Drug Evaluation and Research (CDER) at the FDA weighs the risks and benefits of new drugs, but thorough oversight of approved medications is lacking, claims the report. Several changes must be made if this situation is to change. Some of these adjustments include:

  • Stabilizing the leadership of the FDA by having the President appoint the FDA Commissioner for a 6-year term. The Commissioner could be removed only for cause;
  • Having CDER appoint an Office of Drug Safety staff member to each New Drug Application review team;
  • Having CDER employ more expert staff and train its present staff to expand their expertise in a number of areas; and
  • Posting all new drug application review packages on the Agency's Web site.

One of the main issues of contention between the public and the FDA has been that pharmaceuticals manufacturers are seen as being financially and politically involved with FDA personnel, leading to at least a perception of Agency bias toward promoting drug company interests. To combat this, the committee of the Institute of Medicine recommends that the majority of the members of FDA-related advisory committees be unconnected by any financial involvement with the drug companies whose products are being analyzed.

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