Drafts of PDUFA, MDUFA Released in House, Senate

Posted 19 April 2012 | By Alexander Gaffney, RAC 

Congressional committees responsible for the oversight of the US Food and Drug Administration (FDA) released discussion drafts intended to start the debate over the reauthorization of the Prescription Drug User Fee Act (PDUFA).

The Senate Health, Education, Labor and Pensions (HELP) Committee's discussion draft, The Food and Drug Administration Safety and Innovation Act (FDASI), comes before a 25 April hearing to reauthorize PDUFA, the Medical Device User Fee Act (MDUFA), and three other pieces of proposed legislation.

The additional pieces of legislation are aimed at combating counterfeiting in the pharmaceutical supply chain, relieving drug shortages and giving antibiotics special development incentives similar to orphan drugs.

The House Energy and Commerce Committee released its own discussion draft in advance of its 18 April hearing on PDUFA and MDUFA, which is reportedly quite similar to the draft released by the HELP Committee.

FDA Directors Janet Woodcock of the Center for Drug Evaluation and Research and Jeffery Shuren of the Center for Devices and Radiological Health testified at that hearing, arguing on behalf of the FDA-submitted recommendations for the PDUFA and MDUFA legislation.

Both the HELP Committee and Energy and Commerce Committee are reportedly looking at bringing the proposed legislation before their full committees-instead of just their healthcare subcommittees-for a full vote sometime in May, with the measure going before the full chamber sometime after that.

The PDUFA and MDUFA legislation will exceed their previous authorization on 30 September.

Read more:

Wall Street Journal - Senate, House Panels Plan Votes On FDA User-Fee Bills Next Week

HELP Committee - Executive Session - S. ______, the Food and Drug Administration Safety and Innovation Act

House Energy and Commerce Committee Discussion Draft (h/t Drugwonks.com)

Regulatory Focus - House Meets to Discuss PDUFA, MDUFA User Fees

FDA - FDA User Fees 2012: How Innovation Helps Patients and Jobs (JS)

FDA - FDA User Fees 2012: How Innovation Helps Patients and Jobs (JW)

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