Congressional, Pharmaceutical Industry Tampering with FDA Threatens Drug and Medical Device Safety, Endangers Consumers
June 5, 1997
The Senate Labor and Human Resources Committee is poised to make significant changes to the Food and Drug Administration (FDA) through a bill 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 advocates fear the changes will jeopardize drug safety and, thus, endanger the lives of millions of Americans. On Wednesday, June 11, the Senate Labor and Human Resources Committee will mark-up the "Food and DrugAdministration Modernization and Accountability Act of 1997," a complicated piece of legislation for which there have been no public hearings. Among other things, AIDS Action is concerned that the draft bill:
1) lowers safety and efficacy standards for new drugs and for off-label uses of approved 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 and cancer.
2) threatens 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 calls for FDA reform 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.
AIDS Action, which represents a community dependent upon an effective and efficient FDA to maintain its health and, in some cases, to save lives, would support key administrative changes in the FDA but opposes efforts to undercut the agency's fundamental mission of protecting the public health and safety. AIDS Action believes that, as the drug development process experiences explosive changes and the development of new families of AIDS drugs - especially more effective treatments and a vaccine - places unprecedented demands on the FDA, the FDA needs the flexibility to maintain its reputation as the "gold standard" for drug approval.
AIDS Action averts provisions to deny legal immigrants, undocumented individuals access to federal health care
Under intense pressure from AIDS Action, immigrant advocacy groups, and the White House, the Human Resources Subcommittee of the House Ways and Means Committee dropped controversial provisions in the "Chairman's mark" that would penalize legal immigrants and undocumented individuals living with HIV and AIDS.
One of the provisions advocated by Rep. Clay Shaw (R-Fla.), chairman of the Human Resources Subcommittee, would essentially exempt HIV treatment from the communicable disease exception language that was legislated as part of immigration reform in the 104th Congress. Under current law, access to testing and treatment for communicable diseases is available to legal immigrants and undocumented individuals for reasons of public health. Shaw's provision would differentiate HIV disease from all other communicable diseases and remove access to HIV treatment. Hill staffers on both side of the aisle warned Wednesday that similar provisions might eventually be resurrected.
There are other troubling immigration provisions still in the mark which fall far short of what was promised in the bipartisan budget agreement. For example, the budget agreement restores SSI and Medicaid benefits to legal immigrants who are now disabled and legal immigrants now in the country who may become disabled at some later date. The subcommittee mark only restores SSI and Medicaid benefits to legal immigrants who are already receiving these benefits as of August 22, 1996, when the welfare reform bill was signed into law.
At a time when the science and politics of AIDS are fast evolving, AIDS Action will host its first annual State of AIDS Forum on July 14 at the National Press Club. The forum, which will be underwritten by Bentley Health Care, Inc., is part of AIDS Action's continuing efforts to shape the national debate around AIDS. The forum's morning session includes a two-hour media-oriented briefing at the National Press Club. An afternoon session will feature a dialogue between AIDS Action staff and the leaders of AIDS Action's community-based member organizations nationwide. AIDS Action represents all Americans affected by HIV and AIDS and over 1,400 community-based organizations that serve them. Results of five newsbreaking reports will be released during the morning media briefing, including the latest statistical data on HIV/AIDS from the Centers for Disease Control and Prevention (CDC), presented by Dr. Helene Gayle, director of the CDC's National Center for HIV, TB, & STD Prevention.
Also presenting will be AIDS clinicians, AIDS health educators, AIDS policy experts, and the chief executive officers of two community-based organizations (AIDS Project Los Angeles and AIDS Resource Center of Wisconsin). A question-and-answer session will follow the presentations and will involve a roundtable-type discussion among and between members of the media, presenters, and the forum's other participants. The afternoon session is closed to the media. More information, including media credential applications, will be forthcoming from AIDS Action's Communications department.
AIDS Action Council
This article was provided by AIDS Action Council.