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Government Must Ensure All People with HIV/AIDS Can Access Standard of AIDS Care Released by NIH

AIDS Action announced its unequivocal support for the standard of AIDS care guidelines released Thursday (June 19) at a National Institutes of Health (NIH) press conference. AIDS Action stressed, however, that for the guidelines to be meaningful there needs to be an increased federal commitment to getting AIDS drug therapies into the hands of all Americans living with HIV and AIDS. Specifically, AIDS Action called for the expansion of Medicaid eligibility to people in early stages of HIV infection, and for increased funding for the AIDS Drug Assistance Program (ADAP) and for all other Ryan White CARE Act programs.

AIDS Action proposed its Medicaid expansion initiative to Clinton administration officials over three months ago, citing current Medicaid eligibility criteria as contradictory to AIDS clinical evidence and care standards which call for early treatment of HIV disease. While over 53 percent of all Americans with AIDS rely on Medicaid for access to health care, many low-income people with HIV are denied that access. People with HIV are ineligible for Medicaid unless the Social Security Administration declares them disabled -- which usually follows diagnosis with full-blown AIDS. In April, Vice President Gore called on the Health Care Financing Administration (HCFA) to report within 30 days on the feasibility of Medicaid expansion. That report has yet to be released.

State ADAP programs are facing a $132 million budget shortfall this year, which has forced many states to limit their drug formularies or deny coverage for some people. In Mississippi, for example, hundreds of people with AIDS were dropped from ADAP earlier this month because of a severe budget shortfall. AIDS Action has been fighting to get Congress to appropriate emergency funding for beleaguered ADAPs. An attempt to attach ADAP supplemental funding to a disaster relief bill was defeated earlier this month.

The Senate Labor and Human Resources Committee passed a bill Wednesday (June 18) aimed at amending the Food, Drug & Cosmetic Act, one of the nation's most important and fundamental pieces of consumer protection legislation. AIDS Action and other patient and consumer advocacy groups are vehemently opposed to the legislation, instead urging that Congress maintain a strong Food and Drug Administration (FDA). AIDS Action opposes the bill because it makes significant changes to the FDA that could jeopardize drug safety and, thus, endanger the lives of millions of Americans. AIDS Action is concerned that the bill proposes to:

1. lower safety and efficacy standards for new drugs. By presuming that one study for the approval of new drugs is sufficient, this bill micromanages scientific decisions and fails to require thorough clinical research by drug companies. There is no way to predict in advance how many clinical studies might be necessary to determine a drug's safety and usefulness. The FDA must maintain the flexibility to make informed scientific judgments and require the appropriate number of safety and efficacy trials before allowing companies to market drugs for serious diseases such as AIDS.
2. threaten the reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA is largely responsible for the significant improvements in the FDA's review and approval of new drug applications and faster patient access to promising new therapies. Ironically, the FDA reform calls are coming from the pharmaceutical industry and Congress at a time when the average time period for FDA reviews of applications has decreased dramatically. The average time it takes for a new drug to be approved has been cut in half, from 29.2 months in 1992 to 15.5 months in 1996.

Pharmaceutical, Business Lobby Continues Push for Repeal of FASA, Vital AIDS Drug-Purchasing Program

Earlier this month, AIDS Action succeeded in averting the repeal of the Federal Acquisition Streamlining Act (FASA). Under FASA, state and local agencies could purchase products and services -- including AIDS drugs -- at reduced prices that are currently available only to federal agencies. The compromise agreed to earlier this month by a House-Senate Conference Committee resulted in a moratorium on FASA's implementation through the end of this session of Congress. The moratorium was put in place in hopes that hearings on FASA could be held over the summer. The hearings would allow consumers and representatives of state and local governments an opportunity to speak to the merits of the program. However, the likelihood of such hearings, indeed future implementation of FASA and its drug-purchasing program is threatened by a "repeal FASA" coalition funded by the pharmaceutical industry and the business lobby. AIDS Action is fighting against FASA's repeal because FASA could allow beleaguered AIDS Dr ug Assistance Programs (ADAPs), public hospitals, and state and local health departments the opportunity to purchase AIDS drugs at up to a 40 percent discount. State ADAPs face a budget shortfall of $132 million this fiscal year.

AIDS Action's 1997 State of AIDS Forum to Define Nation's Debate Around AIDS in 1997 and Beyond

America's leaders in the fight against AIDS will convene in Washington, D.C., July 14 for a State of AIDS Forum that will both define and respond to the political, social and scientific challenges posed by an evolving epidemic. The forum comes at a time when the AIDS community is grappling with the implications of promising AIDS drug therapies, an historic decline in AIDS deaths, and the need to re-define our national and local response to AIDS. The forum will bring together chief executive officers of the nation's leading AIDS service providers, Clinton administration officials, public health and AIDS policy experts, clinicians, and people living with HIV and AIDS. Dr. Helene Gayle, director of the Centers for Disease Control and Prevention's (CDC) National Center for HIV, STD & TB Prevention, and Sandra Thurman, director of the White House Office of National AIDS Policy, are both confirmed attendees. The forum begins at 9 a.m. in the Main Ballroom of the National Press Club in Washington, DC.

AIDSfax is a service provided by AIDS Action, the nation's foremost AIDS advocacy organization.

For more information, contact: José Zuñiga, director of communications, at (202) 986-1300 Ext. 3042.

AIDS Action: The National Voice on AIDS
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