AIDS TREATMENT NEWS No. 110 - September 7, 1990
John S. James
* Adopting "a national policy ... to foster the development of new drugs for AIDS and cancer." A permanent oversight committee, appointed by and reporting to the Secretary of Health and Human Services, would monitor the needs and performance of the FDA in drug regulation. (Note: the importance of this recommendation is that today there is no such national policy, and no one responsible when the system as a whole is not working. Each office just does its own job, even when it is clear that disaster will result.)
* Severe staff and equipment shortage at the FDA can be addressed not only by providing more resources, but also by allowing institutional review boards, and outside contractors approved by the FDA, to do some of the reviews now done by staff. The Committee recommended that phase I trials could optionally be approved by a qualified institutional review board (IRB) instead of by the FDA. Also, pharmaceutical companies could optionally pay the FDA to rapidly review an NDA (marketing) application by contracting the work to outside experts. These changes are necessary because "Congress has placed many new responsibilities on the FDA in the last decade, while the number of employees in the agency has decreased.... In the short term no quick solution is apparent to these inadequate resources."
* FDA advisory committees should have a much larger role, with their own staffs, and responsibility for their own agendas.
* Medicare, Medicaid, and private insurance should pay for experimental drugs and unlabeled uses of approved drugs, and all associated medical care, "if the use has been approved by expert government agencies, in authoritative medical compendia, or by a committee established by the Secretary of Health and Human Services. " Coverage should be the same under Medicare, Medicaid, and all private insurance, and should not vary between geographic areas. Individual insurance companies "should have no discretion with respect to such matters."
* Earlier marketing approval for AIDS and cancer drugs should occur as soon as there is credible evidence of efficacy, with other research being completed after approval. The Committee noted that the large phase III trials, which commonly take years, have little practical impact on approval, since 90 percent of drugs which pass phase II also pass phase III. In addition, "It is only after initial NDA approval of the drug as a single entity that its full potential is realized, because physicians are then free to use it in combination with other drugs in accordance with their best clinical judgment. While still under investigation, such combination uses occur only infrequently and with little opportunity for full clinical exploration. For all of these reasons, large phase III studies have been, and should continue to be, conducted in the post-approval setting."
* Other recommendations include support for community-based trials, for parallel track if it does not delay trials, and for the FDA's responsiveness to patient advocacy groups. It urged improved relationships between FDA and pharmaceutical-company personnel, with more open communication.
To obtain a copy of the report, contact the Committee's executive secretary: Dr. Elliott H. Stonehill, National Cancer Institute, Bethesda, MD 20892, 301/496-1148.
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