Harmful Drugs Law
Have our congressional representatives proposed any new laws or regulations regarding the safety of Avendia?
Yes. Senator Chuck Grassley and Representative Rosa DeLauroled a bipartisan oversight committe regarding the safety of Avandia. After the Journal of the American Medical Association's (JAMA) June 2010 reports regarding the diabetes drug Avandia, the members of Congress issued the following statements regarding the safety of Avandia:
Senator Chuck Grassley: “The serious issues delineated in these two new, independent reports put additional onus on advisory committee members when they meet in July. 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.”
Representative Rosa 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.”
Previously, in February 2010, Grassley and Chairman Max Baucus expressed concern about regarding whether the FDA had taken appropriate actions to protect patients from dangers associated with taking Avandia. Notably, the congressional committee raised concerns about whether the Avandia manufacturer (GlaxoSmmithKline) was aware of heart attack risks associated with the Avandia, whether the company sufficiently warned patients and the FDA of the dangers, and whether the company attempted to create doubt regarding negative findings about the drug.
If the FDA's concerns are correct, GlaxoSmithKline may face legal troubles under product liability laws.