House passes PDUFA bill 387 to 5


WASHINGTON — The House of Representatives on Wednesday passed legislation that reauthorizes the Food and Drug Administration’s prescription drug user fee programs that are scheduled to expire in September. H.R. 5651 passed the House by a vote of 387 to 5.

The bill, a version of which already passed through the Senate, now heads to committee where the House and Senate versions of the bill can be reconciled before Oct. 1 and submitted to the president. According to published reports, the Senate version would require more scrutiny for some new devices.

The House's FDA Reform Act of 2012 (H.R. 5651) includes reforms to the FDA’s current evaluation and approval processes for prescription drugs and medical devices that makes the process more efficient, transparent and consistent, noted bill sponsor Fred Upton, R-Mich. Under current law, U.S. companies have been put at a competitive disadvantage with overseas manufacturers, who already benefit from a more streamlined approval process, Upton noted in a statement released Wednesday.

Upton expected a final bill to reach the president’s desk by early summer.

H.R. 5651 reauthorizes for five years the Prescription Drug User Fee Act and the Medical Device User Fee Act. Under these user fee agreements, the FDA collects fees directly from medical manufacturers to fund the agency’s drug and device approval processes. The legislation also establishes new user fee programs for generic drugs and biosimilars, and encourages the development of treatment options for children with rare diseases.

Lawmakers must reconcile differences in the bills, such as dates for the FDA to comply with certain provisions and language in the Senate’s version that would require more scrutiny for some new devices.

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