Three-Month Extension Of Prescription Drug User Fee Act 'Not An Option'
Senate, Health, Education, Labor and Pensions Committeeranking member Mike Enzi (R-Wyo.) this week said that a proposal byHouse Speaker Nancy Pelosi (D-Calif.) for a three-month extension ofthe Prescription Drug User Fee Act until Congress can resolvedifferences in House and Senate versions of a bill (HR 2900 and S 1082) to reauthorize the law, which expires on Sept. 30, is "not an option," CongressDaily reports.
Accordingto Enzi, "the American people did not send us here to rubber stampextensions of old programs that we all know need improvement." A Pelosispokesperson said, "Bipartisan negotiations are taking place betweenthe House and the Senate, and we are confident an agreement will bereached in the near future. The goal is to deliver to the president assoon as possible a bill that would guarantee drug safety and speed upthe approval of life-saving medicines."
Staff members have metin recent weeks to resolve some of the differences in House and Senateversions of the bill, which also includes prescription drug safetyprovisions, before lawmakers begin negotiations in conferencecommittee. House and Senate leaders have not yet named conferencecommittee members (Edney/Bourge, CongressDaily, 9/13).
Former FDA Commissioners Cite Importance of Bill
Meanwhile, at a forum this week sponsored by the Center for Congressional and Presidential Studies at the American University School of Public Affairs, David Kessler and Mark McClellan, both former FDA commissioners, cited the importance of passage of a final bill, CQ HealthBeat reports.
Duringthe forum, part of a series titled "A Dialogue on Prescription DrugSafety: Seeking Common Ground," McClellan, director of the Engelberg Center for Health Care Reformat the Brookings Institution, said that the legislation offers "avision for how drug safety can work in the 21st century, and, at leastup to now, it's had strong bipartisan support."
Kessler, dean of the School of Medicineand vice chancellor for medical affairs at the University ofCalifornia-San Francisco, added that both FDA oversight and publicperception of prescription drug safety must improve (CQ HealthBeat, 9/13).
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