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GPhA Says Cuts to FDA Generic Drug Program Would Have ‘Devastating Impact’ on Consumers and Government

WASHINGTON, DC (MARCH 21, 2011) – The Generic Pharmaceutical Association (GPhA), which represents the world’s leading generic drug manufacturers and suppliers, today respectfully told House and Senate leadership 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.”

“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 said. In a letter to House Speaker John Boehner, Senate Majority Leader Harry Reid and Office of Management and Budget Director Jack Lew, GPhA noted that currently more than 2,000 generic drug applications are awaiting OGD action and that as many as 365 of those are for first time generic drugs, according to the FDA. The result is that consumers and the government are forced to pay more than $200 for a brand drug because many of the generic versions – which cost on average about $20 for a month’s prescription – are caught up in the backlog, GPhA explained.

GPhA said it was working with the FDA to get private sector funding to the Agency by way of a new generic drug user fee program. However, to include OGD now in across-the-board cuts at the FDA would further slow generic approvals at the very time we need more, not fewer affordable medicines on the market. “According to an IMS Health study, generic drugs have saved the health care system $824 billion over the past 10 years…more than $138 billion in 2009 alone,” GPhA said.

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 75 percent of the prescriptions dispensed in the U.S. but consume just 22 percent of the total drug spending. Additional information is available at gphaonline.org.

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