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GPhA Statement on FTC Report on 'Follow-on Biologic Drug Competition'
Date:6/10/2009

ARLINGTON, Va., June 10 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) released the following statement today from GPhA President and CEO Kathleen Jaeger regarding publication of the Federal Trade Commission (FTC) Report on "Follow-on Biologic Drug Competition."

"Today's report from the FTC is yet another endorsement of the need to move forward on passage of legislation that brings affordable biogenerics to patients sooner rather than later. FTC clearly stated that providing the Food and Drug Administration (FDA) with the authority to approve biogenerics would be 'an efficient way to bring these lower-priced drugs to market.' The FTC makes the point that the exclusivity period being pushed by the brands is 'too long to promote innovation.'

"Under Hatch-Waxman, hundreds of millions of patients have benefited from safe, effective and affordable medicines. Moreover, according to a recent IMS Health report, generics have saved the health care system a remarkable $734 billion in the last decade alone. That translates to a savings of one billion dollars every three days - savings that no one thought possible in 1984 and demonstrates the incredibly positive impact that competition has had in the health care marketplace.

"It is important to remember that when Congress debated the Hatch-Waxman Act 25 years ago, the same arguments that we are hearing today about the need for excessive periods of exclusivity, product safety, and generic use by consumers have all been proven wrong. Beyond a shadow of a doubt, Hatch-Waxman has proved that competition from safe and effective generic medicines can truly foster brand innovation while also creating extraordinary savings. Furthermore, when affordable medical options exist, the health care system will adapt and encourage usage.

"As momentum grows on Capitol Hill for passage of biogenerics legislation, both generic and brand companies ha
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SOURCE Generic Pharmaceutical Association
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