US Sen Harkin and others urge FDA to avoid delays of generic drug approvals

Senate Health, Education, Labor and Pensions Committee Chairman Tom Harkin (D-Iowa), along with Senators Jay Rockefeller (Democrat, West Virginia), Charles Schumer (Dem, New York), Debbie Stabenow (Dem, Michigan) and Sherrod Brown (Dem, Ohio) sent a letter to Food and Drug Administration Commissioner Margaret Hamburg urging the Food and Drug Administration to help ensure Americans have access to affordable generic drugs as soon as possible by making timely regulatory decisions.

Patent exclusivity for Pfizer’s Lipitor (atorvastatin), the most widely prescribed drug in US history, is due to expire in June of this year, and introduction of a generic version could save billions of dollars a year for Medicare Part D, Medicaid, Veterans’ Affairs and consumers, the letter stated.

“With several so-called ‘blockbuster’ drugs coming off patent or becoming otherwise eligible for approval in the coming year, we have a strong interest in ensuring a swift approval process for their generic counterparts that may be poised to enter the market. Given the tremendous savings that access to generic atorvastatin will afford both consumers and the government, we urge you to act now to clarify the relevant regulatory issues in this matter so the public can receive access to a more affordable generic version of Lipitor on the earliest possible date,” the Senators wrote.