June 06,2007

Sen. Grassley asks FDA to account for its response to scientific dissent on safety of Avandia

WASHINGTON — Sen. Chuck Grassley has asked the head of the Food and Drug Administration to respond to allegations that a senior agency scientist was reprimanded for formally agreeing with a recommendation that the diabetes drug Avandia needed a box warning for congestive heart failure and stronger warnings about its possible negative effects on eyesight.

"The Avandia case has opened a new round of questions about the way the FDA monitors drug risks and decides whether to let the public know about emerging risks," Grassley said. “It’s another demonstration of the FDA letting the office that’s responsible for putting drugs on the market also call all the shots regarding the post-market surveillance of drugs, despite the expertise that’s contained within the FDA’s office that is responsible for post-market surveillance. For the sake of public safety, I hope to see Congress revisit my legislation on post- market authority.”

Grassley has been conducting active oversight of the Food and Drug Administration and sought administrative and legislative reforms to improve the post-market surveillance of pharmaceuticals. He won Senate approval to double civil monetary penalties levied against drug makers who are knowingly out of compliance with FDA directives during the Senate's recent consideration of legislation to revitalize the drug-safety agency. He also won strong support and fell just one vote short of winning passage for his initiative to make the FDA office that monitors and assesses drugs after they're on the market an equal partner on post-market questions with the FDA office that initially approves drugs for public use.

The text of the letter that Grassley sent to the FDA Commissioner about the new allegations follows here.