GENERIC LEADERS OUTLINE PROSPECTS FOR NEW CONGRESS

As Democrats prepare to take controlof key House and Senate committees,Generic Pharmaceutical Association(GPhA) President and Chief ExecutiveOfficer Kathleen Jaeger expressed optimismthat the fresh start on Capitol Hillwill translate into progress on the industry'skey legislative priorities.

"When the new Congress convenes inJanuary, it will have a real opportunity toimprove the health care of Americans byincreasing access to safe, effective, andaffordable generic medicines," saidJaeger. Topping GPhA's legislative wishlist: creation of an abbreviated approvalpathway for biogenerics.

"The FDA should exercise its responsibilityto create and not keep consumerswaiting for affordable medicines," shesaid in a speech to health care leaders inWashington. "If the FDA can review themore expensive medicines, they shouldalso work on behalf of consumers andreview generic alternatives."

Jaeger specifically called on Congressto enact the Access to Life-SavingMedicine Act, legislation introduced inthe House by Rep Henry Waxman (D,Calif), and sponsored in the Senate byNY Democrats Charles Schumer andHillary Clinton. That bill would help "tobring lifesaving biogenerics to consumers," she said.

Jaeger also stressed the need forCongress toremove otherbarriers tothe marketingof costsavinggeneric drugs, including the useof such tactics as authorized genericsand citizen petitions by branded manufacturersto delay generic competition.Additionally, the GPhA chief urged thenew Congress to reauthorize legislationimportant to the generic drug industry,including the Prescription Drug UserFee Act, the Pediatric Research EquityAct, and the Best Pharmaceuticals forChildren Act.