Henry Waxman speaks about Hatch-Waxman Act at GPhA's meeting

2/24/2009

NAPLES, Fla. Appearing via video at the Generic Pharmaceutical Association's annual meeting in Naples, Fla., to celebrate the 25th anniversary of the Hatch-Waxman Act that he helped write, Democratic California Rep. Henry Waxman said that the market exclusivity model in the Hatch-Waxman Act would work well for biosimilars.

"One of the biggest sticking points in the debate over biogeneric legislation will be the number of years of exclusivity to which brand companies are entitled," Waxman said in video remarks. "The brand industry is calling for 12, 14, 16 and even 20 years of exclusivity. It makes my head spin trying to keep up with their ever-changing arguments for why these terms are justified."

In a panel discussion with GPhA president and CEO Kathleen Jaeger, Biotechnology Industry Organization president and CEO Jim Greenwood said there should be follow-on biologics, that they can be safe and effective and produce competition and savings, but reiterated BIO's position calling for 14 years of market exclusivity. The Hatch-Waxman Act allows a five-year exclusivity period for new drugs.

Still, Greenwood said he was confident that the generic drug and biotech industries would "find enough common ground to serve patients."

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