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Rep. Frank Pallone on the FDA's Decision to Elevate the Office of Generic Drugs within the Agency


Location: Washington, DC

Congressman Frank Pallone, Jr. (NJ-06), Senior Democrat on the House Energy & Commerce Subcommittee on Health, today released the following statement after the U.S. Food and Drug Administration (FDA) announced it will consider elevating the Office of Generic Drugs (OGD) to a "super office," putting it on equal footing with the Office of New Drugs:

"I am pleased that the FDA has agreed to my proposal to move the OGD to the status of a "super office' within the Agency. I have long advocated for the FDA to enhance the role of the OGD and expand the office's ability to expedite the process of moving more generic drugs to the market at a faster rate.

"Last spring, I introduced the Generic Drug Application Review Fairness Act of 2012 as part of the Generic Drug User Fee Agreements of 2012 (GDUFA) to make this same organizational change. While the FDA initially rejected my advice and did not support my bill at the time, I am glad that the Agency has decided to more forward with this important structural change. Generic medicines account for nearly 80 percent of all U.S. prescriptions and are life-saving and cost-effective alternatives for millions of Americans, saving the nation's health care system $931 billion between 2001 and 2010. The FDA's decision to expand the abilities of the OGD is a step in the right direction toward making more generic medications available and improving access to affordable heath care for more Americans"

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