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Generic drug industry praises re-introduction of H.R. 573


ARLINGTON, Va. Missouri Republican Rep. Jo Ann Emerson's re-introduction of H.R. 573, which would prohibit the marketing of an authorized generic drug during the six-month period of generic exclusivity following a successful patent challenge, won praise from an organization representing the generic drug industry Friday.

Normally, the first generic drug company to win Food and Drug Administration approval for a drug has the exclusive right to compete with the branded product for six months. However, branded drug companies will often market their products as authorized generics at a reduced price, usually through third-party companies, thus allowing them to compete with the generic product during the exclusivity period. The FDA regards authorized generics as branded drugs.

The Generic Pharmaceutical Association said in a statement that authorized generics circumvent the intent of the Hatch-Waxman Act of 1984, the law that permits the manufacture of generic drugs, and constitute an attempt by large drug companies to "put profits over patients."

"We applaud Rep. Emerson and the bill?s co-sponsors for working to close this loophole for the benefit of consumers struggling with healthcare costs during these difficult economic times," GPhA president and CEO Kathleen Jaeger said in a statement. 

Reps. Marion Berry, D-Ark., Dennis Moore, D-Kan., and Zach Wamp, R-Tenn., co-sponsored the bill.

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