Washington, DC - The Energy and Commerce Committee is
considering legislation today that will protect consumers from unsafe
prescription drugs. The safety bills are part of a package of nine Food and
Drug Administration-related bills. Earlier this week the Subcommittee on
Health passed the bills on a voice vote.
The FDA has faced severe
criticism over the last few years for approving 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.
U.S. PIRG urged the Energy and Commerce
Commmittee to require the FDA to make the results of drug studies available
on-line to researchers, doctors and patients.
"An on-line database will
allow doctors and patients to weigh the risks as well as the benefits of
taking a drug," said U.S. PIRG Consumer Health Care Advocate Paul Brown. "For
too long this potentially life-saving information has been hidden from public
view."
U.S. PIRG also urged the House Committee, like its Senate
counterpart, to allocate an additional $225 million from drug industry user fees
for post-market drug safety reviews, and to include strong
conflict-of-interest rules for scientists who serve on FDA advisory
panels.
U.S. PIRG also urged the House to give the FDA the authority to
issue hefty fines of up to $100 million for drug makers who fail to
complete follow-up safety studies.
"The fines are a necessary
incentive to get the industry to do the follow up safety studies," Brown said. "Drug makers have failed to complete 70 percent of these studies."
The
Energy and Commerce bills are expected to pass with bipartisan support since
they are 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 bills are scheduled to go to the House floor in early July. The Senate already passed a similar legislation by a 93 to 1 vote in
May.
"The FDA's system for reviewing the safety of drugs has been broken
for a number of years and it has cost consumers their health and their lives,"
Brown said. "Congress must solve the agency's
safety problems."
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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.
