PDUFA Sails Through House of Representatives

Following recent overwhelming passage in the Senate, The Prescription Drug User Fee Act comes closer to becoming law after swift passage in the House of their version of the bill last night by a vote of 387-5. Both bills now move to conference for reconciliation.

The Prescription Drug User Fee Act (PDUFA)  allows for the FDA to collects fees from drug manufacturers to, in turn, improve and expedite the approval process for drugs. The fees collected are used by the FDA to increase efficiency and timeliness with review of license application and increase their medical and scientific staff capability.The revenue generated by PDUFA directly funds two-thirds of FDA reviews. The reauthorization of this bill has allowed for several positive provisions for the rare disease community to be folded into PDUFA V.

We are extremely encouraged by the recent passage in the House and are pleased with the expediency Congress has shown in moving this critical piece of legislation; their hope is to have it to the President’s desk for signature before the July 4th recess. The legislation must be passed by the end of September in order to keep the FDA functioning.

The House and Senate versions of legislation have minor differences in language that now must be reconciled. PPMD has advocated in favor of the final version of the Senate bill that strengthens the patient voice in the process of developing therapies for diseases like Duchenne, as well as thousands of other rare diseases. Both bills attempt to streamline the current process of approving therapies and hold keys provisions that would leverage the Fast Track and Accelerated Review options at FDA's disposal.

PPMD is grateful to everyone in the Duchenne community for their advocacy efforts. Congress continues to hear your voice about the needs of our community and in turn we are seeing progress and results. We will keep you posted as we move forward into passage.


Ryan Fischer, Director of Outreach & Advocacy
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