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Editor: Robert J. Binstock
Profession: Avandia Attorney

Category: Other Avandia News

The type-2 diabetes medication Avandia has been surrounded by controversy in recent months after studies showed a significant increase heart failure risk amongst users. The controversy has put the FDA under the proverbial microscope as well. The recall of Vioxx a few years ago gave the FDA a bad image and recent claims against drugs like Paxil and of course Avandia have reignited the fire. It now appears that the FDA will be getting a much-needed overhaul in the coming months.

A new bill has passed in both houses of Congress and soon will be up for approval by the President, where a veto is highly unlikely. The proposed bill will grant the FDA much more authority and a much greater ability to monitor side effects and adverse events of drugs after approval. Drugs in the approval process will likely be viewed with more scrutiny also.

The FDA will have the power to require companies to conduct post approval clinical trials and have the ability to assess fines in cases of noncompliance. Drug companies will pay a higher fee when submitting new drug applications increasing industry funding by an estimated 25 percent. More government funds will also be appropriated to assist the FDA in their efforts to make the prescription drug market safer.

The new bill likely be signed into law in the not so distant future by the President and optimistically American consumers will be seeing the benefits of the law for years to come.