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AIDS Action Weekly Update

August 16, 1996

Welcome to AIDS Action Council's Weekly Washington Update, an on-line newsletter for Handsnet subscribers that reviews what is happening in Washington on AIDS policy issues each week. If you have any comments or questions, please feel free to contact us at the e-mail address listed below.

AIDS Action Releases 5-Point Aids Agenda For Presidential Candidates

This week, AIDS Action Council released a five-point agenda that should be followed by the next presidential administration in its response to the AIDS epidemic. "The Second Decade of AIDS and The Next U.S. President: A Challenge to Presidential Candidates in Campaign '96," addresses five critical challenges faced by all Americans living with and affected by HIV and AIDS: prevention, research, care, housing, and civil rights. This agenda also makes concrete leadership recommendations on each challenge for the next President of the United States. For full text of "A Challenge to Presidential Candidates in Campaign '96," please contact AIDS Action Council's Communications Manager, Kevin Mercuri, at (202) 986-1300, Ext. 3065. The five-point AIDS agenda is also posted on the World Wide Web at

Consolidated Budget For The Office Of AIDS Research Continues To Be Threatened

Once again, the Office of AIDS Research (OAR) consolidated budget for all National Institutes of Health (NIH) AIDS research was undermined in the FY 1997 Labor-HHS Appropriations Bill passed by the House of Representatives last month. Appropriators have justified their refusal to fund the OAR according to the requirements of the NIH Revitalization Act of 1993 by claiming believing that scientists, rather than politicians, should make allocation decisions within the NIH and that with a consolidated budget, AIDS would be more easily pitted against other diseases such as Alzheimer's or Parkinson's disease. Appropriators also claim their actions have in effect given the OAR more real power through the 3% transfer authority granted in the bill. This transfer authority would enable the OAR to reallocate substantial funding throughout the year between Institutes should they refuse to comply with OAR's strategic plan. AIDS advocates admit that these arguments hold some merit. Unfortunately, none of them address the AIDS community's central concern; that a stable administrative mechanism for guiding the $1.5 billion NIH AIDS research budget is ESSENTIAL in order to avoid waste and enforce the implementation of the OAR Strategic Plan and the recommendations of the Levine Committee Report. Eliminating a consolidated budget would jeopardize the stability required to support studies such as mapping HIV, developing powerful treatments, safe and effective vaccines, and finding a cure. AIDS advocates are asking the Senate to preserve the Consolidated Budget for AIDS Research in the Senate Sub-Committee Labor-HHS Appropriations Bill and insist on the Consolidated Budget in Conference either on a final Labor-HHS Appropriations Bill or on a Continuing Resolution.

FDA Reform Bills In Congress Still Pending Action

Action on the Senate bill revising and reorganizing the Food and Drug Administration (FDA), S. 1477, remains stalled until Congress resumes in September. Senate leadership has suggested that the bill will be considered by the full Senate only IF a deal can be made with the Administration and Senate opponents. While Senate Labor Committee staff assure AIDS advocates that changes are being made, no compromise language has surfaced. The AIDS community maintains their STRONG opposition to the Senate bill especially on provisions imposing arbitrary deadlines on the Agency, allowing dissemination of incomplete and/or inadequate information to market drugs for unproven off-label uses, and permitting third-party review of drugs and medical devices.

The House bills H.R. 3199, H.R. 3200, and H.R. 3201 are being redrafted over the August recess as Commerce committee staff and the Administration continue to negotiate. A discussion draft was released in July which moderated some of the most dangerous provisions in the bill as introduced. However, this draft still includes provisions on off-label use, third party review, preemption of states' authority to regulate food, drugs, and tobacco, and other issues which make it likely that the AIDS community will be opposed to the revised bill as well.

Keystone National Policy Dialogue Releases Report

Last week, the Keystone Dialogue Group released its report on developing a framework to establish studies providing information for optimizing the medical management of HIV infection. This group is composed of government and academic AIDS researchers, clinicians, pharmaceutical manufacturers, third-party health insurers, and community representatives. The group was formed as a result of a February meeting with Vice President Al Gore, pharmaceutical executives and government officials addressing drug development of therapeutics, vaccines, and microbicides to combat HIV. In its report, the Keystone group concluded that innovative trials should be conducted in order to evaluate treatment strategies. The group hopes that in conducting these trials, there is an opportunity to make enormous progress in the treatment of HIV/AIDS. In order for these trials to occur, the group decided to create a forum. In this forum, HIV researchers, health care providers, public and private payers, government regulators, and patient advocacy groups can exchange information and develop and implement new studies to address critical unanswered questions regarding optimal medical management of HIV disease. The forum will take place Fall of 1996. The AIDS community's response to the Keystone Dialogue Group's findings are mostly positive. However, some members of the AIDS community express concern regarding the sources of funding needed to create trials of the magnitude suggested by the report.

For more information contact:
Edna Flores
AIDS Action Council
1875 Connecticut Ave., NW Suite 700
Washington, DC 20009

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This article was provided by AIDS Action Council. It is a part of the publication AIDS Action Weekly Update.