Published Online: Monday, January 1, 2007

As Democrats prepare to take control of key House and Senate committees, Generic Pharmaceutical Association (GPhA) President and Chief Executive Officer Kathleen Jaeger expressed optimism that the fresh start on Capitol Hill will translate into progress on the industry's key legislative priorities.

"When the new Congress convenes in January, it will have a real opportunity to improve the health care of Americans by increasing access to safe, effective, and affordable generic medicines," said Jaeger. Topping GPhA's legislative wish list: creation of an abbreviated approval pathway for biogenerics.

"The FDA should exercise its responsibility to create and not keep consumers waiting for affordable medicines," she said in a speech to health care leaders in Washington. "If the FDA can review the more expensive medicines, they should also work on behalf of consumers and review generic alternatives."

Jaeger specifically called on Congress to enact the Access to Life-Saving Medicine Act, legislation introduced in the House by Rep Henry Waxman (D, Calif), and sponsored in the Senate by NY Democrats Charles Schumer and Hillary Clinton. That bill would help "to bring lifesaving biogenerics to consumers," she said.

Jaeger also stressed the need for Congress to remove other barriers to the marketing of costsaving generic drugs, including the use of such tactics as authorized generics and citizen petitions by branded manufacturers to delay generic competition. Additionally, the GPhA chief urged the new Congress to reauthorize legislation important to the generic drug industry, including the Prescription Drug User Fee Act, the Pediatric Research Equity Act, and the Best Pharmaceuticals for Children Act.

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