Philip Desjardins Weighs in on FDA User Fee Debate in Citeline
Philip Desjardins, Life Sciences & Healthcare Regulatory partner and former official with the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), was quoted in the Citeline article, “Will Kennedy and Makary Come to Terms on User Fees During Next Round of MDUFA Negotiations?” The piece explores the political and policy tensions surrounding the upcoming reauthorization of the Medical Device User Fee Amendments (MDUFA).
Desjardins addressed concerns about “regulatory capture,” noting that medical device firms do not expect the FDA to scrutinize their products with any less rigor because of the fees they pay. Instead, he explained, user fees are viewed as a vehicle through which the agency provides a level of predictability and timing around the review process. “Many large, sophisticated companies get told no on a regular basis,” he said, pointing to the FDA’s continued scrutiny of product safety and data quality as evidence that the system functions as intended.
Desjardins also emphasized the critical role user fees play in maintaining FDA operations, supporting both innovation and public confidence. “One of the things that allows for so much innovation and growth in the medtech sector, particularly in the US, is a healthy and robust FDA regulatory system for industry,” he said. “There’s a level of comfort in launching a product in the US knowing that it went through one of the most strenuous and scrutinized regulatory processes looking at safety and efficacy that can be done.”
