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CCPM Issues Statement on FDA's GIVE Initiative
Date:10/4/2007

WASHINGTON, Oct. 5 /PRNewswire-USNewswire/ -- The Coalition for a Competitive Pharmaceutical Market (CCPM) issued the following statement today on the Food and Drug Administration's announcement regarding its "Generic Initiative for Value and Efficiency" (GIVE):

"With consumers, employers, insurers, and policymakers grappling with how to manage escalating prescription drug costs, it is critical that FDA and Congress continue to focus on ways to enhance timely generic access. Today's announcement of the GIVE program by FDA helps focus attention on the need to bolster the generic drug program, but real work remains on important issues that are hindering consumer access. To achieve this, FDA and Congress must address existing issues including the lack of a workable approval pathway for biogenerics, increased funding for the Office of Generic Drugs (OGD) and stopping brand-name pharmaceutical companies from unfairly extending brand drug patents.

"As momentum grows for access to biogenerics, it is imperative that Congress provide FDA with a clear process for facilitating the development and approval of these life-saving medicines that would give patients affordable alternatives to the brand drugs they need. Regulatory and administrative actions are also needed to restructure OGD programs to ensure timely generic access.

"Finally, insufficient OGD funding is slowing the process of getting generic drugs to market. While we welcome FDA's statement that it will hire and train new generic drug reviewers, sufficient funding is needed to make this wish a reality. Substantially increasing resources for OGD is critical to increasing competition in the pharmaceutical market and getting generics into the hands of consumers. We applaud the Senate and House members of the Appropriations Committees for recognizing the importance of sufficient funding and we hope this needed increase is included in the final legislation."

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