Policy and Medicine: The Food and Drug Administration Safety and Innovation Act (FDASIA): Summary of GDUFA, MDUFA, BsUFA and Pediatrics

Policy and Medicine: The Food and Drug Administration Safety and Innovation Act (FDASIA): Summary of GDUFA, MDUFA, BsUFA and Pediatrics

Policy and Medicine

July 19, 2012

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The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, gives FDA the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.  It also reauthorizes two programs that encourage pediatric drug development.  Below is a brief summary of some of the major provisions contained in FDASIA, provided by various pages on FDA’s website…

Medical Device User Fee Amendments of 2012 

Congress recently authorized the Medical Device User Fee Amendments of 2012(MDUFA III) as part of FDASIA.  MDUFA III will take effect on October 1, 2012 and will sunset in five years on October 1, 2017. 

Device user fees, first established by Congress in 2002, are paid to FDA by medical device companies when they register and list with the FDA, and when they submit an application or notification to market a medical device in the U.S.  (Other parts of the legislation renewed user fees for the review of drug applications.)  Ultimately, MDUFA III represents a commitment between the U.S. medical device industry and the FDA to increase the efficiency of regulatory processes in order to reduce the time it takes to bring safe and effective medical devices to the U.S. market. 

 MDUFA III is the result of more than a year of public input and negotiations with industry representatives and patient and consumer representatives.  Under MDUFA III, the FDA can collect $595 million (plus adjustments for inflation) in user fees over five years.  With the additional funding, the FDA will be able to hire more than 200 full-time-equivalent workers by the time MDUFA III expires in five years.  

In exchange, the FDA has committed to meet certain performance goals outlined in the  Secretary’s letter to Congress (MDUFA III letter).  For example, in fiscal year (FY) 2013, the FDA will issue a decision about whether or not to allow marketing for 91 percent of 510(k) submissions within 90 days.  As provided in the MDUFA III letter, an outside consulting firm will evaluate FDA’s pre-market review process and the agency’s progress in meeting these goals, including timely interactions with industry. 

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By |2017-06-06T16:45:06+00:00July 20th, 2012|Blog, Uncategorized|0 Comments