House Appropriator Shrugs Off FDA New User Fees
House Appropriations Subcommittee on Agriculture chairman Robert Aderholt (R-AL) balked 2/25 at FDA’s proposed $202 million increase in new user fees for FY 2017. During a budget subcommittee hearing, Aderholt said that while there is a time and place for user fees as demonstrated by the success of most of FDA’s user fee programs, the agency’s new request “provides no evidence to demonstrate that current efforts are effective in assisting the intended beneficiaries and that the resources requested for new user fees will result in better services for the customers.” The new fees would cover import certificate processing and food safety-related registrations and inspections.
FDA must also “tighten controls for areas subject to large expenditures with unclear results and where performance tasks or milestones are not met, such as information technology,” Aderholt said. “As noted in a 12/2015 GAO Report, FDA’s IT strategic plan does not identify results-oriented goals and performance measures and milestones, or targets for measuring the extent to which outcomes of IT initiatives support FDA’s ability to achieve agency-wide goals and objectives.”
During testimony, FDA acting commissioner Stephen Ostroff noted that the FY 2017 budget request proposes $2.8 billion, an increase of $116.2 million above the FY 2016 enacted level. The request includes $1.3 billion for budget authority, a 0.2% increase or $3.2 million compared to FY 2016. It also includes $1.4 billion for user fees, a 3% increase or $38.0 million over 2016 levels. “With this request, FDA will improve medical product safety in five key areas: evaluating Precision Medicine-based diagnostics, improving the safety of compounded drugs, combating antibiotic resistant bacteria, supporting animal drug and medical device review, and improving cancer diagnostics and treatments,” he said.
Ostroff also touted the agency’s progress in its device review program. “Our average time to reach decisions on premarket approvals (PMAs)has dropped 36% since 2009,” he said. “And in 2015, FDA approved 79 novel devices, the most since the start of the Medical Device User Fee Program. Most importantly, enhanced flexibility and an efficient approval process have come without lowering our standards for safety and efficacy.” FDA, he noted, is also working to refine clinical trial designs and statistical methods of analysis to create more efficient studies that “take advantage of advances in genomics and information technology to provide more rapid, less expensive and more reliable answers about medical products.”
During questioning by lawmakers, which was mostly devoted to food safety issues, Rosa DeLauro (D-CT) pressed Ostroff on FDA’s review of Bayer’s controversial Essure birth control. The agency has promised a safety review report by the end of the month, and DeLauro said that if FDA extends the review while it collects more evidence then the agency should remove the device from the market until the review is completed. She said the device has over 5,000 reported adverse event reports, including four adult deaths and five fetal deaths associated with its use.
In response to Delauro’s request, Ostroff said that part of budget request for 2017 has to do with moving forward with a national medical device evaluation system. “It is pertinent,” he said, “because that system will allow better monitoring in the postmarket setting and could contribute to issues like this... We said we would be issuing a report by 3/1 and we intend to do so.”