OMB Process Should Embrace Supreme Court’s Wyeth Decision;

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For Immediate Release: March 16, 2009

Contact: Jennifer Fuson
202-965-3500, ext. , ext. 609

OMB Process Should Embrace Supreme Court’s Wyeth Decision;

Provide Notice and Comment Period to Improve Regulatory Transparency

Washington, DC – The Office of Management and Budget (OMB) should embody the principles stated in the U.S. Supreme Court’s majority decision in Wyeth v. Levine in its regulatory review process, according to comments submitted today to the agency by the American Association for Justice (AAJ).  

OMB reviews federal regulations, reports, proposed legislation and budget matters to ensure they are consistent with the Administration’s policies and budget. The submitted comments are in response to OMB’s request for recommendations to improve the principles and processes governing OMB’s oversight functions. 

The principles expressed by the Supreme Court in the Wyeth v. Levine decision include an adequate notice and comment period for federal regulations to improve transparency and public participation in the regulatory process.  Also, the decision recognized the state civil justice system provides an additional consumer protection when government regulations fail, and therefore agencies must limit their attempt to preempt state law, except in cases when Congress has explicitly stated its intent to do so.

The U.S. Supreme Court ruled in Wyeth v. Levine decision that the Bush administration’s Food and Drug Administration (FDA) views on preemption were “inherently suspect” when it finalized the drug labeling rule without the opportunity for public comment.  The final FDA rule at issue in Wyeth included language to preempt state tort law without any analysis of why state and federal law could not coexist.  

“The Supreme Court’s decision in Wyeth provides a roadmap for the Obama administration regarding preemption of state law,” said Gerie Voss, Director of Regulatory Affairs for the American Association for Justice. “OMB should ensure federal agencies comply with the majority opinion of the Supreme Court and preempt state tort laws only when Congress intends to do so.”

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