AEGiS-GMHC: Contracting Out the FDA: An Update

Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

Contracting Out the FDA: An Update

GMHC Treatment Issues, Volume 10, Number 5 - May 1995
Derek Link

Over the last six months, "FDA reform" bills have progressed at a slow but steady pace through both houses of Congress (see January's Treatment Issues, pages 1-5). The Senate Labor Committee passed in late March an amended version of S.1477, Sen. Nancy Kassebaum's (R-KS) FDA bill, S.1477, now awaits consideration on the Senate floor, a debate which has not yet been publicly scheduled. The House Commerce Committee introduced its FDA reform proposal in late March too. No action has been taken on the House FDA plan, although a subcommittee vote could occur soon.

The Senate bill passed the Labor Committee with nine amendments. Several of these, particularly the ones offered by Sen. Dan Coats (R-IN), came as a surprise assault. The bill had gradually evolved into a moderate proposal, but the Coats amendments undid much of the consensus building. They would force the FDA to immediately contract with private consultants for the review and approval of all medical devices, broaden the grounds for privatizing FDA's other key responsibilities, and dramatically lower safety, purity and effectiveness standards for drugs, devices and foods.

Patient advocates opposed Coats' amendments on the grounds that the regulatory system must be built on sound public health principles and rigorous, objective clinical research. Privatization should therefore proceed cautiously, in these advocates' view. There is no private sector industry immediately capable of taking on FDA's tasks. Even if Congress rushes ahead with farming out FDA activities, it will take time for this new industry to develop. Immediate privatization risks slowing drug development by throwing the entire system into chaos.

Also, drug and device makers could hire a private concern to review their products under the Coats plan. This builds conflict of interest into the regulatory system. Reviewers would have an incentive to approve products based on potential future business rather than on an objective examination.

The House Commerce Committee, after keeping its FDA proposals secret for months, released them in late March with much fanfare. At a bizarre media spectacle held in its ornate chambers, the Commerce Committee released three FDA bills -- a bill for drugs and biotechnology products, a bill for foods and a bill for medical devices. Several enthusiastic private citizens, whom the committee brought to the ceremony and described as victims of the FDA bureaucracy, provided a facade of popular support for the measures. Committee members even brought out a cake and sang a sweet song through teary eyes for a heart disease patient from New Jersey. The Committee also announced it had formed an FDA task force of four to guide the bills through the legislative process.

The House bills go far beyond S.1477, even with the Coats amendments. They privatize virtually all of FDA's functions, ranging from the inspection of drug-making facilities and blood banks to the review and approval of all drugs, devices, blood and biotechnology products. The House bill lowers safety and effectiveness even more than the Senate bill, allowing drugs to be sold with no clinical research whatsoever. The bill also allows higher levels of pesticides in food and restricts the FDA's ability to inform the American public about the dangers of products on the market.

AIDS organizations, and GMHC in particular, have helped lead the public opposition to the Republican FDA proposals. A growing array of groups -- patients, seniors, unions, women, minorities, environmentalists and consumers -- have now joined to defeat these bills. But the coalition is coming together in a frenzied and ad hoc manner that is limited both organizationally and financially. Discussions are now taking place as to how to form an aggressive, independent and organized public health lobby for the FDA.

Whether Congressional leaders can pass the FDA bills in both chambers, reconcile the substantial differences between House and Senate proposals, and secure assent from President Clinton remains a matter of much speculation. The growing opposition to the FDA bills, a dwindling legislative year and an intensifying electoral campaign make the likelihood of swift, easy passage decline from day to day. This year may prove to be just a dress rehearsal for future showdowns.

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