The U.S. FDA’s final rule for regulation of lab-developed tests is now a part of regulatory litigation history, but Scott Whitaker, CEO and president of the Advanced Medical Technology Association, said that while Congress is still considering LDT legislation, any new legislation may differ substantially from previous bills.
The U.S. FDA has finally unveiled the fifth edition of the device user fee program (MDUFA V), and some of the performance measures remain unchanged from MDUFA IV, such as that the FDA will process 95% of 510(k) filings within 90 days.
The FDA and device makers have finally wrapped up what may be the most contentious set of negotiations in the history of the device user fee program. Despite industrial antipathy to a recurrent doubling of user fee volumes, the fifth device user fee deal will provide the FDA with as much as $1.9 billion in user fees, roughly double the fees collected under the current agreement.
The U.S. FDA’s device center has posted a report on premarket review performance metrics under the current device user fee schedule, and the latest data show an 83% rate of deficiency in first-cycle reviews of PMA original filings in the last three months of calendar year 2021. That rate is down somewhat from the 91% rate seen in 2016, but is up substantially from the 63% major deficiency rate seen in 2018, the low-water mark for this metric for more than a decade.
The least burdensome principle is a critical component in industry’s understanding of the proper role of government regulation, but this principle is the subject of considerable tension between the two sides. The latest report on the FDA’s performance under the fourth device user fee agreement noted that device makers raised the least burdensome flag in less than 0.5% of 510(k) submissions filed between February 2019 and April 2021, but the report gives the agency passing grades on its handling of those potentially controversial regulatory encounters.
While the FDA has not provided transcriptions for device user fee meetings in roughly five months, the agency is still demonstrably determined to increase the volume of user fees. A source close to the negotiations told BioWorld that the latest proposal from the agency, dated Sept. 22, would require that industry come up with roughly $2.5 billion over the next five fiscal years, more than double the amount under MDUFA IV.
Negotiations between the FDA and industry over the next device user fee are going on behind closed doors, but the agency’s summaries of these meetings suggest there are sharp disagreements. While the FDA continues to press industry on additional fees for the total product life cycle advisory program, industry’s dissatisfaction with the FDA’s fiscal management of the user fee program has prompted a demand for a one-off audit of the agency’s use of those user fees.
The FDA and industry are deep into the negotiations over the next device user fee, with the usual array of concerns such as premarket program performance and the volume of user fees. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), has once again given voice to a perceived need for a significant boost in user fee volumes in an interview with a major trade association, suggesting that device makers can expect a significant uptick in fees for PMAs and 510(k)s in the years ahead.
The negotiations for the next medical device user fee agreement are well underway, but the FDA is pressing the case for a substantial increase in device user fees. While the controversy over the cost of each addition to the FDA staff has not gone away, the agency continues to compare device user fees to drug user fees even though the drug industry is populated by much larger companies, thus nullifying any such comparisons in the view of device makers.
The past two device user fee schedules have essentially doubled the volumes collected in the prior fee agreements, a pace that some in industry have described as unsustainable. That issue was front and center again in the first public meeting for the next user fee agreement, with FDA commissioner Stephen Hahn saying the agency’s device center needs more money, and industry representatives arguing that the bulk of the device center’s funding must be obtained through congressional appropriations, not from industry-funded user fees.
