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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U.S. PIRG is the federation of state
Public Interest Research Groups. State PIRGs are non-profit, non-partisan
public interest advocacy organizations.
