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FDA Reform in Congress: AIDS Community Absent




 

AIDS TREATMENT NEWS #220, April 7, 1995

Far-reaching FDA reforms are now being proposed by Congressional Republicans, who may have the votes to force major changes in how FDA operates. The goal of many of these changes is faster and less expensive approval of important new drugs; but some proposals could also increase the risk of ineffective drugs being approved (the advocates insist that standards for safety will not be affected). As FDA reform moves with unexpected speed into prominence in the Republican Congressional agenda, it is important that those concerned about AIDS be involved in the process and make our views known. But so far the AIDS community is largely ignorant and unengaged in what is happening with this issue.

A number of proposed reforms will be discussed next week in hearings by Senator Nancy Kassebaum (Republican, Kansas) of the Senate Labor and Human Resources Committee -- who, incidentally, is regarded as an important friend of people with AIDS, due to her work on reauthorization of the Ryan White Care Act. At the hearings, scheduled for April 5 and 6, legislation to amend the Food, Drug, and Cosmetic Act is expected to be introduced. As we go to press we do not know what the legislation will contain, but the following proposals have been discussed: * Accelerated Approval. Under current law, a drug cannot be approved without "adequate and well-controlled trials" (generally interpreted as more than one trial). A proposed change would require the FDA to approve a drug if the risk of the drug is no greater than the risk of the condition, and the drug is reasonably likely to be effective in a significant number of patients. This judgment could be based on expert opinion; under the proposal, phase III efficacy trials would not necessarily have to be done before approval. FDA's refusal could be taken to court, and conceivably the courts could order the FDA to approve the drug.

* Phase I/II Testing. Another proposal would allow IRBs (institutional review boards) to approve a phase I or phase II test of a new drug; the FDA would have to be notified, but its approval would not be required before the trial could proceed. The FDA would still have to approve phase III trials; and sponsors could submit phase I and phase II protocols to the FDA, instead of to an IRB, if they wished.

[Comment: This change could be important in reducing the great difficulty of getting the earliest human data on new treatment ideas. Current law gives the FDA 30 days to reply to an application for an IND; if it does not reply, the trial can go forward. But sometimes, just before the deadline, the researchers receive a long list of objections which would be almost impossible to satisfy. Some experts believe this happens because the FDA does not have the staff to meet the 30-day requirement, and is controlling its workload by effectively eliminating some research proposals. In any case the impact may be greatest on creative ideas that do not already have widespread support -- and may in part be responsible for the lack of creative ideas in AIDS treatment research. Allowing IRBs to approve early trials could bypass this bottleneck.] * Off-Label Information. Currently the FDA greatly restricts the ability of companies to distribute information about unapproved uses of approved drugs -- even though some unapproved uses become the standard of care in widespread use by physicians. A proposed change would allow companies limited distribution of information about unapproved uses, through a special section in advertisements or by giving peer-reviewed scientific publications to physicians or others. This could help physicians be more educated about de facto new uses of drugs when those uses have not been approved by the FDA.

These are only a few examples of some of the proposed legislative changes which would affect the FDA. Other proposals are intended to speed the advisory-committee process, allow easier export of experimental drugs when legal in the receiving countries, allow minor manufacturing changes without prior FDA approval, and preventing the RAC (Recombinant Advisory Committee) at the U.S. National Institutes of Health from having separate jurisdiction over clinical trials, in order to focus this jurisdiction in a single agency, the FDA.



 


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Information in this article was accurate in April 7, 1995. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.