The Generic Pharmaceutical Association (GPhA) has called on lawmakers to protect funding for the Food and Drug Administration Office of Generic Drugs.


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GPhA: Don't cut funds for FDA generic drug program

March 21st, 2011

WASHINGTON – The Generic Pharmaceutical Association (GPhA) has called on lawmakers to protect funding for the Food and Drug Administration Office of Generic Drugs.

GPhA said Monday that in a letter to House and Senate leaders, it warned that any cuts to funding for the FDA Office of Generics Drugs (OGD) at this time "would have a devastating impact on millions of consumers, employers and other payers who rely on the timely approval of generic drugs to better manage their health care costs."

The association noted in the letter that more than 2,000 generic drug applications are awaiting OGD action and that as many as 365 of the applications are for first-time generics, according to the FDA. As a result, consumers and the government are forced to pay more than $200 for a brand-name drug because many of the generic versions — which cost on average about $20 for a month's prescription — are mired in the backlog, GPhA said.

"While we understand the difficult budget environment in which Congress is operating, the timely approval of additional generics would generate federal savings that far exceed the cost of fully funding the generic drug program," GPhA stated in the letter, which was addressed to House Speaker John Boehner (R., Ohio), Senate Majority Leader Harry Reid (D., Nev.) and Office of Management and Budget Director Jack Lew.

GPhA added that through new generic drug user-fee program, it's working with the FDA to get private-sector funding to the agency. The association pointed out that to include OGD in across-the-board cuts at the FDA would further slow generic approvals when they're most needed.

Citing a study by IMS Health, GPhA reported that generic drugs have saved the nation's health care system $824 billion over the past 10 years, including more than $138 billion in 2009 alone.

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