Senate Passage of FDA "Reform" Bill Threatens Safety of People with HIV/AIDS

WASHINGTON, DC - AIDS Action denounced Senate passage today of S. 830, the so-called FDA "reform" bill. The Senate passed the bill by a vote of 98-2 and House consideration of a companion bill, H.R. 1411, is expected before the end of the year.

"There are few constituencies who support the concept of FDA reform as strongly as the one million people living with HIV/AIDS in America; but few constituencies will be harmed as greatly by this bill," said Daniel Zingale, AIDS Action Executive Director. "Gradual improvements in the approval process have achieved a balance between increased approval time and the protection of consumer safety; the Senate bill breaks this delicate balance."

For those affected by HIV/AIDS, the most egregious and detrimental provision in the bill allows off-label drug marketing. Under the bill, drugs approved for certain uses but also prescribed for unapproved purposes could be marketed for those unapproved uses. The promotion of off-label use would undercut the high efficacy standards at the FDA and would threaten the health and safety of people on certain HIV drug therapies.

"Enactment of off-label promotion could lead to an explosion in unapproved drug uses, dangerously diluting the drug safety process," added Zingale. "FDA reform must be enacted for the benefit of health care consumers, not the health care industry."

AIDS Action has called for an immediate long-term reauthorization of the Prescription Drug User Fee Act, the non-controversial backbone of an improved and more efficient FDA. In the meantime, AIDS Action will be working to ensure that the House version of the bill is enacted without provisions that threaten the important regulatory authority of the FDA.

Zingale added that "wholesale FDA reform must proceed with greater prudence. The lives of nearly a million HIV-affected people depend on it"

Contact: Steve Fisher
(202) 986-1300, Ext. 3065

AIDS Action Council
1875 Connecticut Avenue, NW Suite 700
Washington, DC 20009
(202) 986-1300
fax (202) 986-1345
E-Mail: aidsaction@aidsaction.org