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Parent Project Muscular Dystrophy Endorses Senate Version of Prescription Drug User Fee Act After Patient Voice Strengthened
Date:5/24/2012

HACKENSACK, N.J., May 24, 2012 /PRNewswire-USNewswire/ -- As the U.S. Senate continues debate on legislation that seeks to accelerate delivery of safe and effective therapies to patients and to increase the patient voice as part of the therapy review process, Parent Project Muscular Dystrophy (PPMD) is pleased to offer its enthusiastic endorsement of the legislation.

(Logo: http://photos.prnewswire.com/prnh/20100119/DC39975LOGO)

Over the past several months, PPMD – the leading advocacy organization fighting to end Duchenne muscular dystrophy (Duchenne) – has fought to include several key provisions included in the Senate version of the Food and Drug Administration Safety and Innovation Act, commonly referred to as the Prescription Drug User Fee Act or PDUFA. A number of similar provisions are also included in a House bill expected to be voted on by that chamber next week.

"The provisions included in the Senate user fee bill will help expand the patient voice when key decisions are being made, an issue of grave importance to our community and to the larger rare disease community," PPMD President Pat Furlong said.  "The provisions will also provide the FDA with additional tools to more quickly review potential therapies for life-threatening conditions, including Duchenne."

The organization has also supported expanded external expert engagement on key issues such as benefit/risk and trial design, and has urged the FDA to accelerate the timing of various rare disease-focused activities.

"As Congress works to finalize the user fee legislation, PPMD calls upon the U.S. House of Representatives to amend their version of the user fee bill to mirror the patient representative provisions contained in the Se
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SOURCE Parent Project Muscular Dystrophy
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