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Pallone, Guthrie Call for Fairness in Generic Drug Approval Process

April 3, 2012
Press Release

Bipartisan bill will temporarily fix an unintended consequence of current law and elevate the Office of Generics Drugs within the FDA

WASHINGTON, D.C.—Congressman Frank Pallone (D-NJ) and Congressman Brett Guthrie (R-KY) introduced the Generic Drug Application Review Fairness Act of 2012. The bill would make two important improvements to the Federal Food, Drug, and Cosmetic Act that will ensure continued access to high quality, low-cost generic medicines. Generic medicines, which account for nearly 80 percent of all U.S. prescriptions, saved the nation’s health care system $931 billion between 2001 and 2010. 

Generic drug manufacturers that are first to challenge a patent of a branded pharmaceutical receive 180 days of market exclusivity upon approval, but to be eligible for this benefit they must obtain tentative Food and Drug Administration (FDA) approval within 30 months. However, the median approval time for generic drugs exceeds 30 months. This bill would temporarily double – to 60 months – the length of time for a generic drug to receive FDA approval and this market advantage.  Over the next five years that time would decrease gradually until reverting back to 30 months in 2017.    

“Generic medications benefit patients and taxpayers alike, and more can be done to improve access to these safe and affordable medicines,” remarked Pallone. “I am pleased to join Congressman Guthrie to introduce this bill that would make key improvements to the generic drug review process. It not only keeps Americans healthier, it makes fiscal sense too.”

The bill would also modify the organizational structure at the FDA so the Office of Generic Drugs (OGD) would report directly to the Director of the Center for Drug Evaluation and Research, giving it the same stature as the Office of New Drugs. This direct access would provide the OGD with the ability to access more financial resources within the agency, and hasten decision making in respect to new policies and procedures. 

"I am pleased that Congressman Pallone and I were able to introduce this important bill to help ensure continued access to low-cost prescriptions,” said Guthrie.

The Generic Drug Application Review Fairness Act of 2012 was endorsed by the Generic Pharmaceutical Association.


Ray Zaccaro