AIDS Action Network Fax
June 12, 1997
Clinton Administration Briefs AIDS Action, Other Advocates On HIV/AIDS Program Funding For Fiscal Year '98 And Beyond
Clinton administration officials briefed AIDS advocates Wednesday, June 11, on President Clinton's commitment to maintaining the federal government's investment in HIV/AIDS programs. The briefing was spurred by AIDS Action pressure on administration officials to explain why President Clinton agreed in budget negotiations with the GOP congressional leadership to drop AIDS-specific programs from a list of "protected domestic discretionary priorities." Among the 40 programs dropped from the list were AIDS research at the National Institutes of Health (NIH), HIV prevention through the Centers for Disease Control and Prevention, the Ryan White CARE Act, the Housing Opportunities for People With AIDS (HOPWA) program, and drug treatment through the Substance Abuse & Mental Health Services Administration (SAMHSA). AIDS Action also questioned the administration's failure to request supplemental funding for the AIDS Drug Assistance Program (ADAP), which faces a $132 million budget shortfall in fiscal year 1997. Mississippi's ADAP, for example, was forced earlier this month to cut 640 people living with HIV/AIDS - 80 percent of its clients - from the program because of a budget shortfall. National AIDS Policy Director Sandy Thurman, Office of Management and Budget (OMB) official Nancy-Ann Min, and Clinton advisor Richard Socarides, assured AIDS Action and other national AIDS organizations that the administration intends to push for funding increases for some AIDS programs during its negotiations with Congress on a final budget agreement. Regarding ADAP funding, however, administration officials reiterated their position that there is currently no concrete data on an emergency in the ADAP program and no formal request from the Department of Health and Human Services (HHS) for supplemental funding. AIDS Action continues to work with Clinton administration officials and members of Congress to ensure that the federal investment in AIDS is not jeopardized in the budget process determining funding for FY98 and beyond.
Senate Committee Postpones Action On FDA 'Reform' Bill That Could Threaten Drug Safety, Lives Of American Consumers
The Senate Labor and Human Resources Committee postponed until next week action on a bill aimed at amending the Food, Drug & Cosmetic Act, one of the nation's most important and fundamental pieces of consumer protection legislation. The one-week delay will allow AIDS Action and other patient and consumer advocacy groups to advocate for maintaining a strong Food and Drug Administration (FDA).
AIDS Action fears that the committee, which will now take up the bill next Wednesday, June 18, is poised to make 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.
Before postponing action on the bill, the Senate committee agreed to accept an amendment which extends a national, toll-free AIDS drug clinical trials hotline to offer information about clinical trials for drugs treating other diseases.
AIDS Action endorsed and advocated for passage of the amendment, which is a valuable resource to many people living with HIV/AIDS, and may now offer vital clinical trial information to people living with other diseases.
Pharmaceutical, Small Business Opposition To FASA
May Yet Force Repeal Of Vital Drug-purchasing Program
Earlier this month, AIDS Action succeeded in averting the repeal of a drug-purchasing program which, once implemented, could offer AIDS Drug Assistance Programs (ADAPs), public hospitals, and state and local health departments the opportunity to purchase life-saving drugs at discount rates. The compromise agreed to by a House-Senate Conference Committee resulted in a moratorium through mid-August. Now it appears that implementation of the program, which is part of the Federal Acquisition Streamlining Act (FASA), is threatened by a "repeal FASA" coalition funded by the pharmaceutical industry and small businesses, and backed by Rep. Bob Livingston (R-La.), the powerful chairman of the House Appropriations Committee. Under FASA, state ADAPs could purchase prohibitively expensive state-of-the-art treatments, including protease inhibitors at up to a 40 percent discount. Capitol Hill insiders have warned AIDS Action to expect an aggressive push by FASA opponents for a repeal of this critical piece of legislation. AIDS Action and its partner organization, the National Association of Public Hospitals & Health Systems, are committed to derail any repeal attempts and ensure speedy implementation of the drug-purchasing program.
AIDS Action Warns Caution On "morning After" Treatment, Stresses Condoms, Safer Behavior Are Best Weapons
AIDS Action reacted with caution to news that some medical professionals are considering the use of combination therapy with protease inhibitors as a "morning after" HIV prevention measure for individuals who fear possible sexual exposure to HIV. Besides citing the drugs' side effects and the lack of studies supporting this practice, AIDS Action warned that the so-called "morning after" treatment could wreak havoc on ongoing HIV education and prevention efforts.
AIDS Action fears individuals may abandon feasible prevention measures - use of condoms and safer personal behavior, including abstinence - in favor of a complicated, four- to six-week regimen with an unproved, toxic treatment.
Ironically, the Food and Drug Administration (FDA) issued a health advisory Wednesday, June 11, warning doctors of a potential link between combination therapies with protease inhibitors and diabetes. According to the FDA, as of May 12, 1997, there have been 83 cases of diabetes reported in HIV-infected patients who were receiving combination therapy with protease inhibitors. Additionally, AIDS Action stressed that making promising drug therapies available to HIV-infected individuals who could benefit from the treatments must continue to be a priority. A four- to six-week "morning after" regimen could cost as much as $1,000, a price tag which could further tax an over-burdened health care delivery system. AIDS Action urges the AIDS community to allow science to dictate our response to AIDS, rather than rush into a "silver bullet"solution.
AIDS Action Council
This article was provided by AIDS Action Council.