Vioxx: FDA Statement on Recent Allegations

FDA Statement on Vioxx and Recent Allegations and the Agency's Continued Commitment to Sound Science and Peer Review

The Food and Drug Administration today released the following statement by Acting Commissioner Dr. Lester M. Crawford:

For the past several weeks, various allegations and characterizations have circulated and been reported on regarding FDA's approval and post market review of the drug Vioxx, a "Cox-2 inhibitor," that its sponsor, Merck, voluntarily withdrew from the market September 30th, 2004. I am issuing this statement to further clarify the Agency's activities in this area. It covers four topics:

  • Issues involving allegations about the performance of FDA's Office of Drug Safety;
  • Allegations about a scientific paper submitted to the British medical journal, The Lancet;
  • The possible participation of Dr. Curt Furberg in an upcoming FDA advisory committee to discuss Cox-2 inhibitors; and
  • Further information about FDA's recent announcements to strengthen its safety program for marketed drugs.

First, allegations have surfaced about the handling of the post-market review commissioned by the FDA and managed by the Center for Drug Evaluation's Office of Drug Safety (ODS). In particular, there has been concern about the process used to complete that study and publish it, including allegations that ODS managers disagreed with the project officer's conclusions and sought to modify them. It is critical that all the facts be presented in this case to assure public confidence in our drug safety programs.