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Legislation to Expedite Drug Approval Process Moving Forward

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, we expect the United States House of Representatives Energy and Commerce Committee to pass and send along to the full House for its approval legislation that will impact the Parkinson's community.

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 (more information).  During this reauthorization process, Congress often simultaneously considers and approves related legislation with significance to the Parkinson's community.

This reauthorizing legislation includes the FAST Act, H.R. 4132, which PAN supports and is intended to streamline and hasten the FDA's therapy approval process and to ensure people with diseases like Parkinson's have quicker access to safe and effective therapies.  

Next week, the Senate is expected to vote on its own version of this legislation, which includes portions of the TREAT Act, S. 2113.  PAN also endorsed the TREAT Act, which is very similar to the FAST Act and is intended to expedite drug and device approval and delivery.

There is a strong congressional desire to finalize this legislation by the end of June and the legislation needs to pass by the end of September in order to keep the FDA functioning at its current levels.  Advancement of measures to expedite treatments for Parkinson's and other diseases is a testament to this community's advocacy efforts and 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: May 10 2012