GPhA Statement on FTC Roundtable on Biogenerics

"The mere fact that the FTC is conducting this roundtable demonstrates the growing momentum behind ensuring that consumers have access to safe and affordable biogenerics sooner rather than later. As our elected officials grapple with issues like market exclusivity and patent resolution measures, they must do so recognizing that competition will unleash innovation, while at the same time assuring that affordable lifesaving medicines are available for patients in need.

There is no doubt that a sound balance must be struck between innovation and competition in any truly workable biogenerics legislation. This is why GPhA has consistently stated that Hatch-Waxman serves as a reliable model for achieving this shared goal. Hatch-Waxman has been extremely successful for the brand industry, the generic industry, and most importantly, consumers.

We applaud the FTC and Commissioner Pamela Jones Harbour for their forward-looking leadership in addressing the critical issues of competition and innovation in the biopharmaceutical sector. The generic industry agrees with FTC's position, as stated in its May letter to the House Energy & Commerce Committee, that Congress 'should limit companies' ability to game ... exclusivities at the expense of consumers by ... ensuring there is no opportunity for brands effectively to lengthen their exclusivities through insignificant changes to a branded biologic product or through excessive procedural delays.'

2009, the 25th Anniversary of the Hatch-Waxman Act, can be the year when the new Administration and Congress can truly increase access to affordable health care by passing landmark biogenerics legislation. We are committed to working with President-Elect Obama and all members of Congress to ensure that safe and affordable biogeneric medicines get to patients in need in a timely fashion."

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. Generics represent 65% of the total prescriptions dispensed inthe United States, but only 20% of all dollars spent on prescription drugs. For more information about the industry, visit http://www.gphaonline.org.

SOURCE Generic Pharmaceutical Association (GPhA)

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