Justice:

Drug Safety

Today, the Food and Drug Administration (FDA) approves drugs that would have been rejected in the past because of doubts about their safety or effectiveness. American lives are at risk as a result.

This spring, Rezulin was taken off the market, after causing hundreds of cases of severe liver toxicity and at least 63 deaths. Rezulin was the fourth drug pulled off the market from among those approved in 1997. Only one other time since 1970 were as many as two drugs approved in a year (1985) taken off the market.

In most of these cases, the FDA approved the drugs despite warnings from the agency's own physicians. None of these banned drugs represented a significant breakthrough, so there was no urgent need for rapid approval.

In a 1998 confidential survey, FDA medical officers -- the physicians responsible for the primary reviews of New Drug Applications for drugs -- identified more than two dozen drugs that they believed were mistakenly approved. They reported stepped up pressure from superiors, Congress and the drug industry to quickly approve a high proportion of new drugs.

The so-called FDA Modernization Act of 1997 and other legislative acts have seriously weakened the FDA's regulatory capacity, permitting the manufacturers of many medical devices to rely on private, for-profit companies instead of FDA to review their application, reducing the evidence required to prove safety, and allowing drug companies to promote drugs for purposes for which they were not approved.

The FDA needs new leadership that will refuse to compromise public safety to accommodate industry demands. The FDA Modernization Act and other deregulatory measures must be repealed. And FDA rules permitting direct-to-consumer advertising must be revoked.