May 21,2007

Chairman Baucus and Ranking Member Grassley comment on New England Journal of Medicine report on Avandia


TO: Reporters and Editors

FR: Carol Guthrie, 202/224-4515 for Sen. Max Baucus

Jill Kozeny, 202/224-4515 for Sen. Chuck Grassley

RE: Avandia (rosiglitazone)

DA: Monday, May 21, 2007

Sens. Max Baucus and Chuck Grassley, Chairman and Ranking Member of the Committee on Finance, today made comments and sent letters regarding the contents of a study just released by the The New England Journal of Medicine. The study is on cardiovascular problems linked to Avandia, a pharmaceutical used for the treatment of type 2 diabetes.

Comments from each senator are below, along with the text of their letters to the Food and Drug Administration and GlaxoSmithKline, the maker of Avandia. Sens. Baucus and Grassley are asking the Food and Drug Administration to tell them about what the FDA knew about Avandia and when they learned about it. The senators are asking the drug maker to respond to allegations that company executives sought to silence independent scientist(s) about risks with this particular drug.

Sen. Baucus’ comment:

“What we are learning about the handling of Avandia by both GlaxoSmithKline and the FDA is appalling and unacceptable. Both the drug company and the FDA have some major explaining to do about what they knew about Avandia, when they knew it, and why they didn’t take immediate action to protect patients. The number one priority for drug manufacturers and
the FDA must be patient safety. Medicare and Medicaid patients—and all Americans—must never be put at risk like this again,”
Baucus said.

Sen. Grassley’s comment:

“We need to know if this is another Vioxx, where the FDA sat on its hands and endangered lives. The FDA has talked a good game about how it’s beefed up post-market surveillance over the last two years, but a case like this undermines that claim. It’ll take more than administrative reforms to fix the system within the FDA. Congress ought to take advantage of the opportunity that we have right now with the FDA funding bill to make a real difference for public safety. Study after respected study has said that the FDA office responsible for postmarket review of drug safety ought to have equal footing with the FDA’s drug approval office. It’s hard to understand how there’s any resistance to this kind of reform if you care about public safety and public access to the never ending flow of new information about pharmaceuticals. I won’t stop making the case for giving the post-market review office real clout,” Grassley said.