The Generic Pharmaceutical Association (GPhA) has made clear its concern with the $285 million in proposed cuts to the Food and Drug Administration's (FDA's) Fiscal Year 2012 Budget
This week the association sent a letter to House Appropriations Committee Chairman Hal Rogers (R-Ky.) and Ranking Member Norm Dicks (D-Wash.) to express why it disagrees with this cut.
GPhA and its members recognize that government spending and health care costs are out of control and that the Committee is operating under a tight budgetary framework. However, deeps cuts in FDA's budget could encumber the timely approval of generic medicines, which have proven to provide savings for the federal government and the health care system as a whole.
"This reduction in funding could hinder the ability of FDA's Office of Generic Drugs (OGD) to ensure timely access to safe and affordable generic medicines," wrote in the letter. "Therefore, GPhA respectfully requests that the Committee maintain FDA's budget at $2.457 billion and OGD's budget at $51.545 million."
Currently more than 2,000 generic drug applications are awaiting OGD action, and as many as 365 of those are for first time generic drugs, according to the FDA. As a result, consumers and the government are forced to pay brand drug prices for prescriptions that could be available in affordable generic versions if the FDA is adequately funded.
There are so many drugs awaiting approval because the FDA is underfunded. Delays on this drugs mean that consumers have to wait longer for lower-priced generic drugs. In the long run this is more expensive to not only consumers but also insurers and payors.
For example, in 2010 Medicaid paid on average approximately $200 for each monthly brand prescription, compared to just $20 for a month's prescription in the generic version, according to data from the Centers for Medicare and Medicaid Services. "Further reductions to OGD's budget could worsen this situation and delay the approval of safe, low-cost medicines to patients most in need," Billings said.
GPhA understands the difficult budget environment in which Congress is operating, but fundamentally believes that the approval of more generics will help the overall budget situation. A copy of the letter can be found at http://www.gphaonline.org/sites/default/files/FY%202012%20OGD%20Funding.pdf.