Career staffers at the FDA objected to new drug labeling regulations that favor pre-emption of state liability lawsuits, according to a report from Rep. Henry Waxman’s Committee on Oversight and Government Reform.
The report (found here, with supporting materials) focuses on comments made by FDA staff, claiming the revisions – in 2006’s Physician Labeling Rule and 2008’s Changes Being Effected (CBE) – to drug label regulations were based on a “false assumption,” and made “false and misleading” assertions. A spokesperson for the committee said an investigation is ongoing. The report was released just days before the Supreme Court convenes on Wyeth vs. Levine (November 3), a closely watched pre-emption case that could have far-reaching ramifications for patients and manufacturers.
Pre-emption is the principle that FDA approval of a drug (and its label, usage, etc.) immunizes manufacturers from product liability lawsuits at the state level. In the case Wyeth vs. Levine, Diana Levine was given Phenergan, a Wyeth nausea medication, improperly, resulting in the loss of her arm. She is arguing that despite a sufficiently approved FDA label, Phenergan did not adequately warn patients about the administration of the drug.
The report suggests that Bush administration appointees in the FDA’s Office of the Chief Counsel suppressed dissenting voices on establishing the grounds for pre-emption. Excerpted comments from John Jenkins, director of the FDA’s Office of New Drugs, state that “much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real-time basis. We know such an assumption is false…so it is unwise to suggest that FDA approved labeling is always up-to-date and always contains a full and complete listing of all pertinent risk information.”
Peter Pitts, president of Center for Medicines in the Public Interest, said pre-emption has been supported by both Democratic and Republican officials and by lawyers at FDA. Pitts pointed to a statement made by John Jenkins in the report’s supporting documents suggesting that Jenkins actually favors pre-emption, and said the excerpts in the the Waxman report were taken out of context. In a debate with Public Citizen representative Brian Wolfman today on CNBC, Pitts argued in favor of the FDA labeling revisions, saying that “when you have 50 states determining how drugs should be used…it’s just chaos.”
In an 2003 email to colleagues (found under “supporting documents for section A”), including Janet Woodcock, Jane Axelrad and Steven Galson, Jenkins wrote: “I agree with the idea that we should pre-empt state requirements for labeling drugs. It makes no sense for us not to have a federal system for labeling approved drugs that [are] based on a careful scientific review of the available data and a consistent application of labeling policies across products.” Jenkins went on to say, however, that he is “not so comfortable with the whole argument…about pre-empting state liability cases against a manufacturer for ‘failure to warn’ cases.” Jenkins is presumably referring to Diana Levine, who is suing Wyeth for “failure to warn.”
