The National Health Council (NHC) and the National Organization for Rare Disorders (NORD) submitted a letter to Congressional leaders Friday – undersigned by over 120 patient advocacy organizations – urging them to swiftly pass a bill that reauthorizes FDA user fees under the Prescription Drug User Free ACT (PDUFA).
PDUFA was a law passed by the Congress in 1992 which allows the FDA to collect fees from drug manufacturers to fund new drug development and approval process. According to the letter, reauthorizing the latest PDUFA legislation would promote the patient-focused drug development program, strengthen the breakthrough expedited review pathway, and expand the rare diseases program, among many more positive tools for the rare disease community.
The letter fully endorses the bill (several patient organizations gave input prior to the final draft) and is calling for an speedy passing. According to the letter:
The FDA largely relies on user fees authorized by Congress to operate. Without the user fees, a majority of drug, biologic, and device reviewers would be laid off, and the necessary review of innovative therapies would be substantially impaired, if not halted all together. Further delay, such as a one year extension of the current agreement, will impact FDA’s ability to carry out its vital mission and delay many of the much welcomed improvements included in the Commitment Goals Letters.
We request the Committees of jurisdiction and Congress as a whole keep the user fee reauthorization process timely, bipartisan, uncontentious, and focused on the patients FDA serves every day.
The Senate Heath Committee is set to vote on the bill to reauthorize PDUFA on Wednesday May 10th, 2017.
