Sen. Chuck Grassley (R-Iowa) and Rep. Rosa DeLauro (D-Conn.) on Monday criticized the Food and Drug Administration's stance on the diabetes drug Avandia in the wake of two new medical studies. The studies, in the Journal of the American Medical Association, found that Avandia caused "increased risk of stroke, heart failure, and death" for patients aged 65 and older.
"The serious issues delineated in these two new, independent reports put additional onus on advisory committee members when they meet in July," Finance Committee ranking member Grassley said in a joint statement. "Patients and taxpayers need and deserve a clear response and rationale from the Food and Drug Administration about the safety and efficacy of this drug."
Added DeLauro: "Coupled with the previous findings, these new studies appear to confirm that Avandia is dangerous and should be pulled from the market. The evidence now seems to be overwhelming that taking Avandia significantly increases a patients’ risk of a heart attack, even when compared to a similar prescription drug. This information will make it even more difficult for the FDA to justify keeping this dangerous drug on the market."
Grassley and Senate Finance Chair Max Baucus (D-Mont.) raised concerns with Avandia — and FDA's oversight — in a February report. They have called for fixing the "imbalance between the office responsible for monitoring the safety of drugs after approval and the office that puts drugs on the market in the first place," the joint statement says.
For her part, DeLauro in April chaired a hearing to examine the issues surrounding the safety of Avandia and found similar problems at FDA.
Correction: This post was updated at 11 a.m. Tuesday to clarify that only Rep. DeLauro has suggested Avandia be pulled from the market.