April 07,2005

Chairman Grassley comments on FDA removal of painkiller Bextra


TO: Reporters and Editors
FR: Jill Kozeny, 202/224-1308
RE: Bextra removal
DA: April 7, 2005

Sen. Chuck Grassley, Chairman of the Senate Committee on Finance, issued thecomment below regarding the Food and Drug Administration announcement today that Bextrawould be removed from the market.

Last year Sen. Grassley started conducting oversight of the Food and DrugAdministration in response to concerns about the agency’s handling of information about thedangers of teenager use of antidepressants and the cardiovascular risks associated with thepainkiller Vioxx. In February 2005, Sen. Grassley joined Sen. Christopher Dodd in introducinglegislation that would establish a mandatory clinical trial registry, in order to bring greatertransparency to the drug safety review process. In addition, Sen. Grassley is working to developlegislation that would enhance post-market review of medicines by making the FDA’s Office ofDrug Safety independent from the FDA’s Office of New Drugs.

Grassley comment —

“The burden is on the Food and Drug Administration to bring clarity to the safetyconcerns surrounding this class of drugs. What’s happened with these painkillers has been aconfusing saga for the people who need pain relief, and that can be attributed to systemic failuresby the FDA and misplaced priorities of the drug industry.

“It will be good news if today’s action, which goes further than the recommendations ofthe FDA’s advisory panel, is a turning point and indicates a more independent Food and DrugAdministration. Otherwise today’s action may raise more questions than it gives answers forpatients and their doctors. FDA officials repeatedly say that Vioxx was handled properly, andthat they would act no differently today. It’s hard to see how this squares with suspending thesale of Bextra and increasing the warning level for Celebrex. The FDA needs to chart a steadycourse for its customers, the American public.”