For Immediate Release
Congressional Report Lays to Waste Bush Administration’s Pre-emption Claims
Statement of Brian Wolfman, Director, Public Citizen Litigation Group*
WASHINGTON - A report issued today by the House Oversight and Government Reform
Committee is proof that the Bush administration has pulled out the
stops to shield drug companies from liability for dangerous drugs while
leaving patients out in the cold. The report, based on documents
obtained from the Food and Drug Administration (FDA), concludes that
the agency's efforts to protect drug companies delayed the
dissemination of important safety information to the public. The
documents reveal that top FDA officials who deal with drug safety on a
day-to-day basis do not believe that lawsuits undermine consumer
safety, but their views were overridden by political appointees who
lacked any empirical support for their views.
It's bad enough that politics consistently trumps
science with this administration. But here we have clear documentation
of how the White House hijacked an agency and forced it to undermine
its own mission, which is to protect patients.
The report couldn't be worse timing for the administration, which is arguing Nov. 3 before the U.S. Supreme Court in Wyeth v. Levine
that civil suits arising from defective and mislabeled prescription
drugs are pre-empted by FDA approval of the drug's label. Today's
report shows that the Bush administration's pro-pre-emption position in
that case is motivated by politics and not expertise in drug
regulation. Top-ranking FDA career officials with deep expertise in
drug safety said that the Bush administration's efforts to amend drug
labeling regulations to pre-empt state liability lawsuits were deeply
flawed. The administration's justifications for the regulations were
"false and misleading," they said.
The Bush administration has not limited its pre-emption push to
prescription drugs; it has inserted pre-emption clauses in a wide array
of regulations. Essentially, the White House maintains that victims
should get nothing, no matter how negligent or irresponsible the
company was in designing, testing, labeling or marketing its products.
This effort to prevent injured citizens from using the courts and
holding negligent companies' accountable must be stopped.
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*Wolfman has written briefs for and/or argued dozens of
pre-emption cases involving drugs, medical devices, hazardous
substances, pesticides and other products before the U.S. Supreme Court
and other courts.
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