ARTICLE SUMMARY:
In this week’s Pathways Picks: Doug Kelly leaves FDA, while the Trump administration extends buyout offers to many in the agency; Makary and Dr. Oz move closer to confirmations to lead FDA and CMS; updates from the IMDRF harmonization meeting in Tokyo, where FDA didn’t show up, but Russia’s regulators did; CMS cancels dialysis innovation model; and more from the US, Singapore, Brazil, and Europe.
Editor’s note: Updated March 13 to reflect FDA Commissioner-nominee Marty Makary cleared a committee vote, and two briefs were added: “CMS cancels “innovation” models including ESRD” and “Conditional certificates get notified body nod.”
Doug Kelly departs. CDRH is losing its deputy center director for science and the leader of the TPLC Advisory Program (TAP). Douglas Kelly, MD, announced he is leaving FDA via a March 8 post on LinkedIn. His departure came the same weekend that HHS employees received a buyout offer to leave their jobs (see brief below), but Kelly did not say whether he took that offer.
Kelly, who joined CDRH in 2020, did not come with the typical regulator’s resume. He spent his career as a venture capitalist; former CDRH Director Jeff Shuren hired him to improve the center’s engagement with innovation and start-ups. Kelly’s efforts led to TAP, which is funded as a pilot via the MDUFA V user fee program. Under TAP, companies leverage advisory services from a dedicated CDRH team and outside partners to support a broader market access strategy, including regulatory, reimbursement, and commercial considerations. More than 70 devices have so far been accepted into the program.
The position at FDA “may have been the best and most rewarding job I have ever had,” Kelly said on LinkedIn. Market Pathways interviewed Kelly and leaders of the TAP program multiple times in recent years, including:
