Oct. 29, 2008
Congressional Report Lays to Waste Bush Administration’s Pre-emption Claims
Statement of Brian Wolfman, Director, Public Citizen Litigation Group*
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.
READ the report.
READ related link.
*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.