June 10, 1996
For Information Contact:
(202) 483-6622 ph
Director of Research and Treatemnt Advocacy
(202) 483-1135 fax
What's the problem with FDA Reform legislation?
The National Minority AIDS Council (NMAC) strongly opposes The FDA Performance and Accountability Act ( S.1477) and H.R. 3199, 3200, and 3201. These bills promote irresponsible deregulation of the FDA by permitting drug and device manufacturers to put products in the market without having to prove their safety and efficacy. These bills threaten the health of all Americans with serious and life threatening conditions such as HIV disease. We believe that with these bills the quality, safety and efficacy of new drugs under development will be questionable and potentially harmful.
The provisions in these bills would harm all Americans by undermining crucial public health protections and casting the regulation of drugs, medical devices and foods into dangerous and untested territory. These bills would lower the safety and efficacy standards for new drugs. It would privatize some of the FDA's central regulatory responsibilities by contracting out functions ranging from the review of clinical research data to inspections of manufacturing facilities. Under the systems outlined in the bills, medical device manufacturers, for example, would select and pay the private companies that review and inspect their products, creating a system of regulation built upon inherent conflict of interest. The system would be driven by financial incentives to approve new products rather than objective, public health standards. NMAC believes that FDA reform is about improving the health of all American people and not improving the industry's market and profit.
The National Minority AIDS Council is extremely concerned about these bills due to the fact that the epidemic is clearly moving toward communities of color. If these bills are implemented these communities will be left with a system that will expose them to potentially unsafe and ineffective drugs.
NMAC needs your support:
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PLEASE RETURN TO MOISES AGOSTO, NMAC.
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