2007 MAY BE BREAKTHROUGH YEAR FOR BIODRUGS

Congress will pass legislation to createa clear, efficient abbreviated approval systemfor biogenerics, possibly as early asthis year, former Centers for Medicare &Medicaid Services Administrator MarkMcClellan, MD, PhD, predicted in anaddress to the Generic PharmaceuticalAssociation's (GPhA) annual meeting inPhoenix, Ariz.

"I've always thought it was importantto have a pathway" for the streamlinedapproval of generic biodrugs," he said.McClellan added that legislation to createsuch a system is now a matter "ofwhen, not if."

Others who addressed the meeting,including Sen Orrin Hatch (R, Utah) andRep Henry Waxman (D, Calif), voiced similaroptimism concerning the passage ofgeneric biodrug legislation during the currentsession of Congress.

"It was encouraging to hear speakerafter speaker say that 2007 can be theyear when biogenerics legislation becomesa reality," said Kathleen Jaeger,president and chief executive officer ofGPhA.