Bill Would Order FDA to Enhance Safety Oversight

On May 9 the Senate passed, by a vote of 93 to 1, a bill that would give the Food and Drug Administration (FDA) enhanced power to police the safety of drugs.

It is called the Food and Drug Administration Revitalization Act (S 1082).

A House version of the bill is expected to be passed sometime this summer. After the Senate and House bills are reconciled, a final bill is expected to be sent to the president for signing into law before the federal fiscal year ends in September.

The reason why September is crucial is that the bill also contains a re-authorization of the Prescription Drug User Fee Act (PDUFA), which expires then. PDUFA requires drug companies to pay fees to have the FDA review drugs for which they are seeking market approval. The fees essentially constitute a partial subsidizing of the FDA by the American pharmaceutical industry. The fees were established 10 years ago in response to frustrations by the National Institutes of Health and patients with cancer and rare diseases that drugs were not being reviewed in a timely manner. The user fees allow the FDA to hire more staff to expedite drug reviews.

Whether President Bush will sign a final version of the bill into law is uncertain. Although the Bush administration has not actively opposed the Senate bill, the president said he will veto any bill that has a drug-reimportation clause in it. Such a clause would allow Medicare to buy American pharmaceuticals from Canada or other countries at prices lower than those in the United States.

The safety measures that the FDA would provide under the Senate bill, and possibly under a reconciled Senate-House bill, are numerous. For example, the FDA would focus on the entire life cycle of a drug on the market, not just on the years before approval. It would establish a surveillance system to identify possibly adverse effects of prescription drugs already on the market. It would establish a public database of clinical trials and their results, so that drug companies would be less capable of hiding safety problems. It would restrict direct-to-consumer advertising of drugs. It could order that drug companies place warning labels on medications. Currently, the FDA's authority in this domain is not clearly delineated.

Also, the Senate bill includes the reauthorization of the Better Children's Pharmaceutical Act (BCPA), which grants a six-month patent extension for drugs whose effects have been studied by their manufacturers in children.

APA has testified before the FDA and the Senate several times advocating for improved drug-safety surveillance and clinical-trial access. APA was also involved in negotiations for the Senate bill and is now involved in those for the House version.

Psychiatric News asked Lizbet Boroughs, associate director of APA's Department of Government Relations, how APA views the final Senate bill.“ We strongly support increased postmarketing sur veillance,” she replied. “That was basically brought to light with the SSRI antidepressants and the potential for an increase in suicidal thoughts in the pediatric population.”

The bill is “the most comprehensive drug safety overhaul in more than a decade,” Sen. Michael Enzi (R-Wyo.), a co-sponsor of the bill, asserted. The bill, he added, could also speed the approval of new drugs by giving the FDA more tools to protect people after medications have been approved.

The proposed new safety regulations also dovetail with some of the FDA's own plans, FDA Commissioner Andrew von Eschenbach, M.D., indicated at a National Health Council briefing in Washington, D.C., on April 30. Von Eschenbach said that the FDA will try to ensure new-drug safety by“ building quality in at the front end” of drug development, but that it will also monitor drugs for safety throughout their life cycles.

For example, when he was asked where the FDA is headed in balancing concerns about the safety of antidepressants, he replied that the emphasis will be placed on developing safe medications early on, but that the FDA will continue to be “engaged” in monitoring them for safety after they are on the market.

The text of S 1082 can be accessed at<http://thomas.loc.gov> by searching on the bill number. ▪