US federal pre-emption defended by PhRMA

15 June 2008

The Pharmaceutical Research and Manufacturers of America (PhRMA) has issued a defense of the US Food and Drug Administration's efforts to ensure federal pre-emption of its drug safety regulations over state laws.

Ongoing court cases in the Supreme Court have already, or seem likely to prevent plaintiffs in law suits against drugmakers from arguing for the application of local safety standards (Marketletters passim). The Democratic party-controlled US Congress could introduce a legislative override to a Supreme Court ruling on this issue.

Ken Johnson, the PhRMA's senior vice president, said that "efforts to strengthen the FDA should not be diluted by substituting the opinions of lawyers and juries for the expert judgement of [the] FDA's scientists and doctors."

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