CALIFORNIA AIDS DRUG REGULATION: COOPERATION WITH FDA

CALIFORNIA AIDS DRUG REGULATION: COOPERATION WITH FDA is emphasized in a bill that would create a mechanism for the state to review and approve AIDS therapies. The bill, originally introduced by Assemblyman William Filante, MD, on March 6 and amended in the State Senate on Sept. 1, states that "protocols for investigative new drugs . . . shall be similar to those approved by the FDA, so that the data acquired in such investigations may also be submitted to the FDA."

The bill adds that "it is the intent of the legislature that the procedures [for state approval of drug testing and drug approval] be utilized to supplement federal procedures to the maximum extent possible under federal law to facilitate the development and testing of AIDS-related drugs and that they be utilized, to the extent feasible, in cooperation with the FDA." The bill sets up a regulatory framework for the state to clear AIDS drugs for testing and sale in California if they are manufactured solely within the state.

California Attorney General John Van de Kamp outlined provisions of the legislative effort in a May 21 speech to the Harvey Milk Democratic Club in San Francisco. Van de Kamp said that the legislative effort was needed because of inadequate responses to the AIDs threat by the Reagan Administration and California GOP Governor Deukmejian ("The Pink Sheet" June 29, p. 8).

In a background paper on the proposed legislation, Van de Kamp explained that the bill "reflect[s] the position that coordination between California and the federal government, in the long run, offers the best hope for the development of effective AIDS-related drugs." The bill also reflects "the view that there are numerous valid medical and ethical considerations which compel the use only of carefully developed and monitored drug test trials, that California should not seek to shorten or approve tests less rigorous than are scientifically appropriate, and that the results of any tests conducted under the California statute should be usable to the maximum extent possible in related FDA proceedings," the background paper states.

FDA said it expects to have an official comment on the proposed legislation the week of Sept. 7-11. The agency has asserted federal authority in similar situations in the past, such as laetrile and efforts last year by several states to enact separate OTC tampering legislation.

The bill, AB 1952, establishes an AIDS Vaccine Research and Development Advisory Committee within the California Department of Health that will review requests for AIDS vaccine research grants as well as requests for AIDS drug approvals or exemptions from approval requirements. The proposal requires that the state director of health services, or a designee, will chair the committee and will appoint, within 30 days, four expert committee members.

In making determinations on requests for approval of AIDS-related drugs or exemptions from approval requirements, "the department shall employ persons to conduct reviews of requests," the bill states. "Where necessary, the department shall enter into contracts with appropriate and qualified persons or entities for the review of these requests, including persons with significant experience in conducting or reviewing clinical trials of drugs or physicians with significant experience in treating AIDS patients, or the AIDS Vaccine Research and Development Committee or any member thereof," the proposal states.

The bill would reappropriate $500,000 in funding from the $4 mil. appropriated to the AIDS Vaccine Research and Development Grant Fund, created under existing law. If enacted as currently drafted, the bill would go into effect immediately and require the department to report progress on implementation by July 1, 1988 and annually thereafter. The California bill, which cleared the State Senate Appropriations Committee Sept. 3, has to go back to the full Senate and then to the Assembly for concurrence before going to the Governor. Van de Kamp's office predicts the bill will reach the Governor before Sept. 11.