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    GPhA Statement On Sens. Kennedy-Enzi-Clinton-Hatch Biogenerics Legislation

Generic Pharmaceutical Association (GPhA) President and CEO Kathleen Jaeger yesterday released the following statement regarding legislation crafted by Senators Edward Kennedy, Michael Enzi, Hillary Clinton, and Orrin Hatch that would authorize the Food and Drug Administration to approve biogenerics:

"GPhA applauds the bipartisan efforts of Members of the Senate Health, Education, Labor and Pensions Committee to facilitate the ultimate passage of 'The Biologics Price Competition and Innovation Act of 2007.' However, we continue to have significant concerns about two specific provisions of the Manager's Amendment that would unnecessarily delay getting safe, effective, more affordable biogenerics into the hands of consumers.

"First, we continue to oppose the extension of 12 years of market exclusivity that this legislation grants brand biotechnology companies. Such an arbitrary and excessive period of time is not only unprecedented and unwarranted, but more importantly, would unjustifiably delay access to affordable competition and choice for consumers and businesses alike.

"Second, we believe another flawed provision would permit brand companies to make a minor change to their product and receive an additional 12 years of exclusivity. This provision could allow brand companies to make multiple minor changes to their products and receive 12 years for each change, in effect maintaining their monopolies in perpetuity. This practice, commonly known as 'evergreening,' would essentially prevent safe and affordable life saving biogenerics from ever reaching patients. We have been informed by Senate staff that this is not the true intent of the compromise agreement forged by the Senate and will work with the negotiators to craft language that addresses this issue.

"Once again, we commend the extraordinary efforts of the Committee to craft a long-overdue pathway for safe and effective biogenerics. However, we must underscore that changes to the underlying bill must be made in order to ensure that this bill achieves the very real potential of this legislation and ultimately gains our support. None of us want to participate in a process that produces little more than an empty promise. We are confident that working together in good faith with all stakeholders-consumers, businesses, health plans, Governors, and representatives of the pharmaceutical industry-the Congress can and will produce a workable legal and regulatory pathway for 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. Unbranded and branded generics represent 63% of the total prescriptions dispensed in the United States, but only 20% of all dollars spent on prescription drugs.

Publication Date: 2007-06-29 03:00

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