Internal FDA documents revealed by Congressman Henry Waxman show that "key FDA career
officials strongly objected to Bush Administration drug labeling
regulations that would preempt state liability lawsuits, asserting that
the central justifications for the regulations were ‘false and
misleading’ and warning that the changes would deprive consumers of
timely information about drug hazards."
Read the documents and Waxman’s report here.
On Monday, in the shadow of the election, the US Supreme Court will hear the case of Wyeth v. Levine, where the drugmaker claims that FDA approval of drug labeleing should preempt state product liability cases. (Read the Wall Street journal’s backgounder on the issue.) Actor Dennis Quaid spoke before Waxman’s committee recently about how the lawsuit he filed against Baxter over the overdose of his newborn twins would be stopped by the wrong ruling, as would almost every suit against drugmakers. The Supremes are expected to rule for the drugmakers as they did previously in the Medronics case, which involved ending lawsuits over FDA approved products (as distinguished from drugs). Waxman has vowed legislation to restore any rights the court takes away. This could be an early and big test for America’s next president. Hopefully the Supreme Court will give more deference to the FDA career officials than the lame duck president and his drug industry chronies.