| Washington Wrap-Up |
An FDA proposal to apply user fee revenues to retention bonuses for its medical device employees got short shrift from industry negotiators at an August 31 meeting, according to minutes released by the agency.
At a previous meeting, FDA had proposed that user fee revenues could be used to enhance scientific review capacity, reduce the ratio of review staff to supervisors, and conduct additional training. At the August 31 meeting, industry negotiators proposed instead that the agency and industry work together to “benchmark best practices for retaining employees, in contrast to the agency’s proposal of developing targeted retention bonuses to address attrition of review staff.”
Industry suggested that the agency find a way to shrink the ratio of review staff to front-line supervisors without having to use funding from new user fees. Industry also suggested that the agency spend user- fee revenue to better utilize the experts it already has on staff rather than hire new ones. FDA said it could not shrink that ratio without hiring additional staff, something it cannot do with its current resources.
Industry also pushed for the agency to put more of its current funding toward writing guidance documents, to which the agency responded with “concern” that MDUFA does not allow for industry to “dictate the reallocation of taxpayer dollars to certain issues,” according to the minutes. Additionally, industry proposed that CDRH fund a reviewer certification program with user-fee revenue, and that all recently hired reviewers be required to go through the program.
The agency released the minutes on October 13—43 days after the meeting. It did not explain why it took so long to issue minutes. Perhaps FDA wanted to give all 27 listed participants a chance to massage the document.