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GPhA Statement on the Release of the Obama Administration’s FY2010 Budget

Arlington, VA, May 7, 2009 – The Generic Pharmaceutical Association (GPhA) released the following statement today from GPhA President and CEO Kathleen Jaeger regarding the release of the Obama Administration’s FY2010 budget:

“According to an independent analysis conducted by IMS Health, commissioned by GPhA, generic medicines have saved our country a remarkable $734 billion over the last decade. Savings achieved in just 2008 reached $121 billion, which equates to approximately $1 billion every three days. (www.gphaonline.org)

“Given this extraordinary savings, it is critical that our government invest in increasing access to safe, effective and affordable generic medicines. With the President rightfully looking for programs that work and save money, adequately funding FDA’s Office of Generic Drugs (OGD) is definitely the place to start. A very modest investment in OGD clearly reaps extraordinary dividends for consumers and the health care system.

“With respect to generic user fees, as we have stated in the past, the generic industry remains open to a generic user fee program so long as there are guarantees that the fees would result in the timely review and approval of generic applications. The end game is to assure timely consumer access to safe and affordable generic medicines. The brand drug user fee program does just that by imposing specific performance metrics to ensure timely reviews. The generic industry is seeking similar guarantees that are afforded to the brand industry.

“It is critical that the Administration and Congress support robust investments in OGD. The process of implementing generic user fees will not happen overnight and, without additional funding for OGD, consumers will continue to see delays in the availability of affordable generics. As the GPhA savings study shows, just a 3% increase in generic use across the nation produces about $10 billion in added savings.

“As the White House and Congress work to reform health care, our shared goal must be to work together to increase generic use. By doing so, we will increase access to care while also saving our government and consumers money.

“Another way to increase savings and access to care is to pass biogenerics legislation. We are pleased that the President has supported a workable scientific, regulatory and legal approval pathway that contains innovator exclusivity provisions consistent with the Hatch-Waxman model. As we have seen from today’s study, the exclusivity provisions of Hatch-Waxman have been a successful model in the traditional drug sector, fostering innovation and competition while saving hundreds of billions of dollars. This same success can be achieved with biogenerics.”

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. For more information about the industry, visit www.gphaonline.org.

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