Published Online: Sunday, April 1, 2007

Congress will pass legislation to create a clear, efficient abbreviated approval system for biogenerics, possibly as early as this year, former Centers for Medicare & Medicaid Services Administrator Mark McClellan, MD, PhD, predicted in an address to the Generic Pharmaceutical Association's (GPhA) annual meeting in Phoenix, Ariz.

"I've always thought it was important to have a pathway" for the streamlined approval of generic biodrugs," he said. McClellan added that legislation to create such a system is now a matter "of when, not if."

Others who addressed the meeting, including Sen Orrin Hatch (R, Utah) and Rep Henry Waxman (D, Calif), voiced similar optimism concerning the passage of generic biodrug legislation during the current session of Congress.

"It was encouraging to hear speaker after speaker say that 2007 can be the year when biogenerics legislation becomes a reality," said Kathleen Jaeger, president and chief executive officer of GPhA.

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