Regulatory Focus™ > News Articles > FDA Misses MDUFA Deadline, Putting Legislation in Jeopardy

FDA Misses MDUFA Deadline, Putting Legislation in Jeopardy

Posted 17 January 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has missed a deadline mandated by the Medical Device User Fee Act (MDUFA) of 2007 to submit a new user fee proposal for approval by congress, reports Bloomberg Businessweek.

The MDUFA legislation charges medical device manufacturers fees to submit their products for FDA approval, which in turn allows FDA to hire more review staff to review products expeditiously.  Under the 2007 iteration of MDUFA, FDA needed to submit a new MDUFA proposal to congress by 15 January 2012.

The MDUFA negotiations are still ongoing, according to Karen Riley, public affairs specialist at FDA, who noted negotiators have met 29 times over the proposed user fee act. The House Energy and Commerce Committee is due to hold a hearing on the legislation on 15 February. FDA Center for Devices and Radiological Health Director Jeffery Shuren is scheduled to testify at that hearing.

Missing the 15 February deadline could lead to legislative delays for MDUFA-and political ramifications for FDA.  MDUFA is set to expire in September, making the prospect of any slowdown in the legislative process a dangerous one for FDA and the pharmaceutical industry alike. The loss of MDUFA funding could leave FDA unable to compensate portions of its review staff.

The political ramifications for the agency are just as dire. The FDA "will have the wrath of a bunch of exercised politicians on them who are running for re-election and want their pictures on T.V. that night" if no agreement is reached, said Washington Analysis Senior Health Policy Analyst Ira Loss in an interview with Bloomberg.

Congress typically leaves Washington, D.C. several months early during an election year to return to their respective districts and campaign. The current congressional calendar has both the Senate and House of Representatives leaving town on 3 August, and not returning until 10 September.  The House is only scheduled to be in session for eight days in September, and the Senate for only eleven.

The presence of national political conventions for both the Democratic and Republican national parties is adding to the scheduling snafu, as the Congress adjourns for the better part of two weeks to attend their respective conventions.

The must-pass nature of the user fee bills currently before congress could also make them a tempting target for political amendments that could further slow the legislation.

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