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Washington, DC — Consumers scored a victory today over the powerful pharmaceutical industry when the House voted 403 to 16 to pass drug safety legislation as part of a comprehensive Food and Drug Administration reform bill.
“This is a big victory for consumers,” said U.S. PIRG Consumer Health Care Advocate Paul Brown. “Drug companies will have to reveal more complete information about their drugs. For too long the drug industry has hidden reports that showed their drugs in a less than flattering light.”
The Food and Drug Administration Amendment Act of 2007 (H.R. 2900) is a comprehensive FDA bill that includes drug safety reforms. The reforms are in response to safety problems with several FDA-approved drugs such as the pain reliever Vioxx and antidepressant Paxil that were later shown to cause dangerous side effects and deaths. Recently the FDA has been criticized for withholding information about the diabetes drug Avandia that links it to increased risks of heart attacks.
“This bill will refocus the FDA on its original mission of ensuring that our medicines are safe,” said Brown.
The bill requires the FDA to:
- Make the results of clinical drug studies available on-line to researchers, doctors and patients.
- Allocate an additional $225 million from drug industry user fees for post-market drug safety reviews.
- Strengthen conflict-of-interest rules for scientists who serve on FDA advisory panels.
- Consider fines of up to $50 million for drug makers who fail to complete follow-up safety studies.
The House bill is part of must-pass prescription drug user fee legislation that provides nearly $400 million of the Food and Drug Administration’s $1.5 billion budget. The Senate passed a similar bill by a 93 to 1 vote in May.
“In several areas, the House bill improves on the Senate version,” said Brown. “It makes more clinical studies available to doctors and patients, increases fines if drug companies fail to do safety studies, and includes stronger conflict-of-interest rules.”
Later this month, the bills will go to a House-Senate conference committee.
“U.S. PIRG urges Senate and House leaders to keep prescription drug safety reforms in the final bill,” said Brown. “These reforms will keep consumers healthy and save lives.”
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