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GPhA Urges Congress to Strengthen Obama Administration’s Call for Increased Funding for FDA

Arlington, VA, March 9, 2010...The Generic Pharmaceutical Association (GPhA) today issued the following statement from Kathleen Jaeger, President and CEO of GPhA, on the testimony of FDA Commissioner Margaret Hamburg, M.D., before the Senate Agriculture Appropriations Subcommittee:

"Given the critical mission of the FDA to protect the public health, it is incumbent upon Congress to provide the agency with the resources it needs to fulfill this mission. There is no doubt that the FDA's Office of Generic Drugs (OGD) is severely underfunded. The administration's $51.5 million budget request for OGD--a $10 million increase over last year--is a meaningful step toward improving the office's funding. We encourage Congress to significantly increase this investment in OGD. Even a modest investment will produce significant savings. With generic medicines saving the health care system one billion dollars every three days, putting more resources into bringing safe and effective generics to consumers is a sound investment.

"We applaud Subcommittee Chairman Herbert Kohl (D-WI) and Ranking Republican Sam Brownback (R-KS) for their determination to give the FDA sufficient resources to ensure consumers have access to the affordable medicines they need. GPhA is committed to working with the Obama Administration and Congress to ensure that the dedicated FDA scientists and reviewers have the resources at their disposal to move the agency forward.

“As the Commissioner has stated, it is unacceptable that OGD has nearly 2,000 pending new generic drug applications. It is unacceptable that the current review time has swelled to 26 months, nearly one and a half years longer than the six-month review period permitted under federal regulation. This situation will only worsen over the next five years as patents expire on brand name drugs totaling more than $100 billion in annual sales, resulting in a surge of submissions of generic drug applications.

“The generic pharmaceutical industry recognizes that the president’s budget also includes a proposed user fee program. We welcomed the commissioner's comments at GPhA’s 2010 Annual Meeting that significant performance metrics will be built into any proposed user fee program. We have repeatedly stated that our industry is open to discussing user fees, but it must be a meaningful program with measurable results.”

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals and suppliers of other goods and services to the generic drug industry. Generics represent 74 percent of the total prescriptions dispensed in the United States but only 22 percent of all dollars spent on prescription drugs. For more information about the industry, visit www.gpahonline.org.

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