Wednesday, March 04, 2009

United States Supreme Court Rules for Consumer, against claim of Drug Preemption

Opinion just came in today, and it's worth a read:

Held: Federal law does not pre-empt Levine’s claim that Phenergan’slabel did not contain an adequate warning about the IV-push method of administration.

Footnote 11 is worth your read alone:

11In 1955, the same year that the agency approved Wyeth’s Phener-gan application, an FDA advisory committee issued a report finding“conclusively” that “the budget and staff of the Food and Drug Admini-stration are inadequate to permit the discharge of its existing responsi-bilities for the protection of the American public.” Citizens AdvisoryCommittee on the FDA, Report to the Secretary of Health, Education,and Welfare, H. R. Doc. No. 227, 84th Cong., 1st Sess., 53.

and ...

(“The [FDA] lacks the resources needed to accomplish its large and complex mission . . . .There is widespread agreement that resources for postmarketing drugsafety work are especially inadequate and that resource limitationshave hobbled the agency’s ability to improve and expand this essentialcomponent of its mission”); GAO, Drug Safety: Improvement Needed inFDA’s Postmarket Decision-making and Oversight Process 5 (GAO–06–402, 2006), (“FDA lacks a clear and effective process for making decisions about, and providingmanagement oversight of, postmarket safety issues”);