A comprehensive FDA bill that includes prescription drug safety reforms is
scheduled to go to the House floor “under suspension” this Wednesday. U.S. PIRG
urges lawmakers to pass the bill.
The Food and Drug Administration
Amendments Act of 2007 is a response to consumer advocates who charge that the
FDA is too lax on prescription drug safety, especially on follow-up safety
issues. More than 70 percent of follow-up studies are never completed by drug
makers.
Over the last few years, the FDA has
approved several drugs such as the pain reliever Vioxx and
antidepressant Paxil that were later shown
to cause dangerous side effects and deaths. Most recently, the FDA has been
chastised for withholding information about the diabetes drug Avandia that links
it to increased risks of heart attacks.
“This is good news for patients and
consumers,” said U.S. PIRG Consumer Health Care Advocate Paul Brown. “For 15
years the FDA has put the pharmaceutical industry first by speeding their drugs
to the market. The House bill shifts the FDA’s priorities back to patients and
consumers by focusing on their safety.”
U.S. PIRG strongly supports safety
provisions in the bill that will:
- • Require
the FDA to make the results of most 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.
- • Give the
FDA the authority to issue hefty 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. Later this month, the bill goes to a
House-Senate Conference Committee to work out the details of the final
bill.
“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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U.S. PIRG is the federation of state
Public Interest Research Groups. State PIRGs are non-profit, non-partisan
public interest advocacy organizations.
