Medco CEO Lays Out Generic Industry Action Plan
The generic pharmaceutical industry should be focusing on three main goals: establishing a pathway for follow-on biologics, closing the citizen petition “loophole” and increasing funding for the FDA’s Office of Generic Drugs (OGD), Medco Chairman and CEO David Snow said at an industry conference.
It is “mandatory” that Congress pass legislation to create a pathway for follow-on biologics, and the Access to Life-Saving Medicine Act, S. 623 and H.R. 1038, is “a good start,” Snow said during his keynote address at the Pharmaceutical Care Management Association’s Pharmacy Benefit Management & Generic Pharmaceutical Issues Symposium June 19. “I think everyone … who has a vested interest in seeing generics on the market should support this bill.”
The citizen petition “loophole,” another key issue, is where brand companies use the citizen petition process to halt generic drug entry, Snow said. Under the current system, the FDA does not continue to review an abbreviated new drug application (ANDA) while considering any citizen petitions that are filed.
A bill, originally introduced as the Lower Priced Drugs Act, is now being incorporated into legislation to renew the Prescription Drug User Fee Act. The legislation would “eliminate this opportunity to block progress” by allowing the FDA to concurrently review an ANDA and any citizen petitions, Snow said.
Snow also called for increased funding for OGD through generic user fees. “It’s absurd to me that there is any excuse to not fund that office properly,” he said. “The reason they can’t get the applications through the system is because they’re grossly understaffed.”
A Generic Pharmaceutical Association spokeswoman said that the group considers all of Snow’s goals important, but that it still believes that citizen petition abuse and authorized generics need to be addressed before user fees would be able to help speed generic drug entry. According to Snow, these goals are easily attainable by the next presidential election.Upcoming Events
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