The Generic Pharmaceutical Association (GPhA) outlined its priorities for 2006 at its annual meeting, held recently in Boca Raton, Fla. Priorities include the codification of a flexible and definitive abbreviated approval process for generic biopharmaceuticals, a halt to the practice of authorized generics, the creation of a biodefense pharmaceutical sector, and reform of the Medicaid program.
GPhA outlines priorities for 2006 at annual show
The Generic Pharmaceutical Association (GPhA) outlined its priorities for 2006 at its annual meeting, held recently in Boca Raton, Fla. Priorities include the codification of a flexible and definitive abbreviated approval process for generic biopharmaceuticals, a halt to the practice of authorized generics, the creation of a biodefense pharmaceutical sector, and reform of the Medicaid program. GPhA president/CEO Kathleen Jaeger told conference attendees, "Generic medicines are a vital part of ensuring that health care will remain affordable and accessible to all Americans. Given the enormous pressure to hold down costs in the U.S. healthcare system, it's clear that the generic industry will continue to play a key role in leading America into a healthy future." Jaeger also told attendees that the FDA is interested in exploring user fees for generics, but Congress needs to take steps now to provide additional funding for the Office of Generic Drugs (OGD). "A modest investment in OGD-such as $15 million-would help to make more affordable medicines available to consumers and public and private healthcare purchasers, who would save billions of dollars. Just a 1% increase in the use of generics nationwide would save $4 billion annually," she said. She added that OGD currently has a backlog of more than 800 generic drug applications. That number is expected to increase as more than $100 million in brand products are expected to lose patent protection by 2010.
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