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ABA Journal Examines FDA and Pre-emption

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ABA Journal, November 2008: The Pre-emption Prescription – The FDA is claiming total responsibility for drug and medical device safety.

  • “The FDA had been signaling its new attitude of tort reform regarding prescription drugs and medical devices since 2001, when a new administration at the FDA began gearing up to file “friend-of-the-court” briefs in state and federal courts claiming that federal regulations pre-empted the power of states to enforce deficiencies—or even deceptions—in prescription drug warnings. To critics like James O’Reilly [Univer­sity of Cincinnati College of Law], FDA pre-emption is part of a series of legal and political maneuvers that all but neu­tered the federal agency in the public eye as a regulator of public health and safety. To supporters, the agency has become far more responsive to the public need for development of new drugs and medical devices.”
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