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US Senate Approves Legislation to Expedite Approval of New Drugs and Therapies

The Parkinson's Disease Foundation (PDF) has received another important update from the Parkinson’s Action Network (PAN) about the Medical Device User Fee Act (MDUFA) and the Prescription Drug User Fee Act reauthorizing legislation.

From PAN:


Today, by a vote of 96-1, the United States Senate approved legislation which will impact the Parkinson's community. Thanks in part to your advocacy efforts, measures to expedite treatments for Parkinson's and other diseases should soon be signed into law.

Every five years, Congress must reauthorize legislation – the Medical Device User Fee Act (MDUFA) and the Prescription Drug User Fee Act (PDUFA) – which enables the FDA to collect fees from the pharmaceutical and medical device industries to partially fund the agency's efforts to approve new drugs and therapies.  During this reauthorization process, Congress often simultaneously considers and approves related legislation, much of which is relevant to the Parkinson's community.

Today's Senate passed legislation includes portions of the TREAT Act; S. 2113, which PAN endorsed, and is intended to expedite drug and device approval and delivery by allowing researchers to use more types of scientific evidence that can be measured to prove the safety and efficacy of drugs.

In the coming weeks, the House is expected to pass its version of the FDA User Fee bill, which includes the FAST Act, H.R. 4132.  PAN also endorsed the FAST Act, which is similar to the TREAT Act and also intended to streamline and hasten the FDA's therapy approval process and ensure people with Parkinson's have quicker access to safe and effective therapies. 

The final legislation must be signed by the president by September 30 in order for the FDA to continue operating at current levels; however, Congressional leaders have indicated that they intend to finalize this legislation by the end of June because of its importance in maintaining core FDA functions.  We will keep you apprised of developments.


PAN is the voice of the Parkinson's community in Washington, DC.  In fiscal year 2012, PDF is supporting PAN with a grant of $200,000.

Source Date: Dec 31 1969