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CALIFORNIA ATTORNEY GENERAL PREPARING AIDS BILL TO PROVIDE STATE R&D SUPPORT AND OKAY FOR INTRASTATE PRODUCTION AND MARKETING: LAETRILE REVISITED?

Executive Summary

An intrastate AIDS drug research and regulatory initiative is being considered by the California Attorney General's Office as a way to encourage drug development within the state and to sidestep FDA regulation. California Attorney General John Van de Kamp is preparing a legislative plan that would set up a system for testing and approving AIDS drugs manufactured and sold within California. Also being considered is a funding mechanism to allow the state to make research grants to small California companies that are engaged in AIDS drug research and development. Van de Kamp, a Democrat, outlined the philosophical framework of the California initiative last month in a speech to the Harvey Milk Democratic Club in San Francisco. In the speech, Van de Kamp charged that both the Reagan Administration and California GOP Governor Deukmejian have responded inadequately to the AIDS threat. "We should take responsibility for testing and approving AIDS drugs out of the hands of the FDA," Van de Kamp said in the May 21 speech. "We need a separate crash program devoted exclusively to finding, testing and distributing drugs that will treat and cure this disease." Van de Kamp maintained that the system would be designed for products to be made and marketed exclusively in California. He said that manufacturers that win "state approval could only test and sell their drugs in California." The attorney general also recommended creating an "academic consortium" between the public and private sectors, "to serve as the link between research, testing and patient care." Such a program, he suggested, could be "run by, or in conjunction with, the University of California." He noted that the University of California is budgeted to spend nearly $10 mil. to develop and operate five clinical drug trial centers. Van de Kamp added that the consortium could make central facilities available "for testing and correlation of viral cultures and antigens. It could create a central registry of protocols for testing and treatment." The consortium might also be responsible for setting research goals and priorities and maximizing the efficiency of research designs to complement academic efforts. "It would be our version of the Manhattan Project -- to wit, the California Project." Such a program, he said, could be the "largest, most ambitious research project ever undertaken on AIDS." FDA has not had formal contact with Van de Kamp's office on the AIDS proposal. However, the concept raises federal preemption of a state approval system/states' rights questions as in the cancer-treatment situation in the 1970's. The California Assembly has already taken legislative steps in the area of AIDS. Last September, an AIDS vaccine bill, AB 4250, was signed into law. The bill "would limit the liability of certain manufacturers of an AIDS vaccine to those circumstances when an injury is caused by negligence or willful misconduct of the manufacturer." The bill also exempts the manufacturer from liability for injuries caused by a failure to warn of possible adverse effects. The bill provides for $20 mil. to be appropriated for creation of the AIDS Vaccine Guaranteed Purchase Fund, for competitive purchase of at least one million doses of an FDA approved vaccine over a three-year period. Another $6 mil. would be appropriated to subsidize human clinical trials of the vaccine, and $50,000 would be set aside for the task force which the bill would create. An AIDS Victims' Compensation Fund would be established to assume liability for injuries caused by the vaccine. The California AIDS initiative was noted in a class action suit filed in D.C. federal court on June 24 by the National Gay Rights Advocates. The suit seeks "judicial review of the actions and inactions of HHS, FDA, NIH, and the Secretary, Commissioner, and Director of those organizations" with regard to AIDS therapy research and regulation. The complaint states that while FDA put approval of azidothymidine on the "fast track," there are other drugs that have shown promise and should also be approved for treatment of AIDS patients. Among the drugs cited by the suit are alpha interferon, Isoprinosine, peptide T and ribavirin. The suit also asserts that "NIH concentrated its research into NIH-sponsored drugs, or into drugs developed by companies with which NIH or its researchers had developed special relationships." The complaint was prepared by the D.C. firm of Swidler & Berlin. The National Gay Rights Advocates are seeking to require FDA to publish the standards used for the Retrovir (AZT) approval and to assure that "all AIDS-related drugs will be treated consistent with that standard."
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