Wednesday, May 23, 2012

Bill includes reauthorization of PDUFA, which adds fees for generic and biosimilar developers.

from Genetic Engineering & Biotechnology News

Insight & Intelligence™ : May 23, 2012

FDA Reform Legislation Emerges as Exception to Washington Gridlock

The fifth five-year authorization of the Prescription Drug User Fee Act (PDUFA V) is shaping up as a welcome exception to the rule that in a presidential election year, Congress cannot get much of anything done until after the votes are counted in November. Well before Election Day, the Senate and House of Representatives are expected to hammer out and pass a single FDA reform bill that includes PDUFA V.

“We need to enact this user fee bill by the end of June. We are on track to accomplish this goal,” Rep. Fred Upton (R-MI), chairman of the House Energy and Commerce (E&C) Committee, said. He has called for sending a bill to President Barack Obama before July 4. The Senate moved its bill onto its calendar for floor action; the House is expected to do likewise.

The Senate and House have produced two very similar versions in recent weeks. “I would say it’s pretty surprising how significantly they lined up,” Nancy Bradish Myers, president/founder of Catalyst Healthcare Consulting, told GEN. “The politicians realized that each one of these user fee agreements had good agreement between the agency and industry. They realized that with an election year, if they wanted to go home and claim to have done something significant on the healthcare front that actually helps people get the medicines they need, that a bipartisan agreement needed to be done carefully and quickly.”

for complete article, please visit http://www.genengnews.com/keywordsandtools/print/3/27255/

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