Industry, FDA Reach User Fee Agreement
BY LAUREN UZDIENSKI, FEBRUARY 1, 2012
Reuters and others are reporting this morning that the FDA and industry have reached an agreement for the FY2013 re-authorization of MDUFA, the legislation that allows the FDA to collect user fees from industry. User fees contribute about a third of the agency's budget.
After a long negotiation process, including one missed deadline last month, industry has reportedly agreed to pay the FDA about $595 million over the next five years, up from $287 million in MDUFA II. Minutes from a January 31 meeting between industry and the agency cite the $595 number, and assuming other details from that proposal are included in the final agreement, funds will be used to support hiring additional staff, process improvements and IT upgrades.
Specific goals discussed at the January 31 meeting include PMA decisions within 320 FDA days, if the submission goes to panel, with targets to ramp up from 50% of submissions received in FY13, to 70% in FY14, 80% in FY15-16 and 90% in FY17. For 510(k)s, the FDA proposed a decision within 90 FDA days, ramping up from 90% of submissions in FY13-14 to 95% in FY15-17. Reuters reports that the FDA has also agreed to "hire an outside consultant to analyze its review system."
