September 12,2007

Sen. Grassley comments on newly released JAMA articles and commentary regarding Avandia

Sen. Chuck Grassley issued the comment below regarding the analysis released today by JAMA, the Journal of the American Medical Association, regarding the safety of the diabetes drug Avandia. Sen. Grassley has conducted active oversight since 2004 of the drug safety program of the Food and Drug Administration. He has documented and sought legislative reforms to address the agency’s too-cozy relationship with the pharmaceutical industry and its reactive rather than proactive approach to post-market surveillance of pharmaceutical drugs.

“This analysis and commentary sums up a case study in what’s wrong with the drug safety system inside the FDA. From drug approval to post-market surveillance, FDA reform is important, because public safety is at stake. Above all, FDA leaders need to adhere to the scientific process and use an even-handed approach with drug-safety deliberations. The FDA’s relationship with drug makers is too cozy and is costing the agency its credibility and the public’s confidence.”