GPhA Statement on FTC Roundtable on Biogenerics

Saturday, November 22, 2008 General News J E 4
ARLINGTON, Va., Nov. 21 The GenericPharmaceutical Association (GPhA) released the following statement today fromGPhA President and CEO Kathleen Jaeger regarding the Federal Trade Commission(FTC) roundtable on "Emerging Health Care Competition and Consumer Issues."

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

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

We applaud the FTC and Commissioner Pamela Jones Harbour for theirforward-looking leadership in addressing the critical issues of competitionand innovation in the biopharmaceutical sector. The generic industry agreeswith 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 noopportunity for brands effectively to lengthen their exclusivities throughinsignificant changes to a branded biologic product or through excessiveprocedural delays.'

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

GPhA represents the manufacturers and distributors of finished genericpharmaceuticals, manufacturers and distributors of bulk active pharmaceuticalchemicals, and suppliers of other goods and services to the generic drugindustry. Generics represent 65% of the total prescriptions dispensed in theUnited States, but only 20% of all dollars spent on prescription drugs. Formore information about the industry, visit

SOURCE Generic Pharmaceutical Association (GPhA)


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