New York Times
September 25, 2008
Re “Drug Label, Maimed Patient and Crucial Test for Justices” (front page, Sept. 19):
The real argument about F.D.A. pre-emption is not whether the Food and Drug Administration sets minimal or optimal standards. Rather, the issue turns on versions of the Watergate questions: What did a company know? When did it know it?
While these questions are tangential in Wyeth v. Levine, they are at the core of litigation involving drugs like Vioxx, Baycol, fen-phen and others. Did the F.D.A. have the information required to make reasonable assessments? Did companies allow the F.D.A. to do so?
The Levine case is an outlier. Hard as it is to believe, the Bush F.D.A. and the Department of Justice have asserted that drug companies should be shielded from civil liability even if F.D.A. approval is based on deliberately faked or hidden data. That is, even if approval is obtained through felony fraud.
That is the core issue regarding F.D.A. pre-emption. The rest is mostly distraction.
Ann Arbor, Mich., Sept. 19, 2008