FDA Under an Acting Commissioner: Six CDER Chiefs in Two Years, 46 Novel Approvals in 2026 and PDUFA VIII Out for Comment

On 9 October 2026 the FDA approved Hovilpri, an antiviral, as its 46th novel drug of the year. That already matches all of 2025, when the agency’s drug centre approved 46 new drugs, down from 50 in 2024. By that measure, the FDA’s core work is holding up.

The agency around it has been in constant motion. The FDA has no confirmed commissioner. Marty Makary, confirmed in March 2025, resigned on 12 May 2026. Kyle Diamantas has been acting commissioner since. The President’s nominee, Heidi Overton, had her Senate HELP committee hearing on 24 September and is waiting for a vote.

The leadership churn

The Center for Drug Evaluation and Research, which approves most medicines, has had a run of leaders unusual for any agency. Its long-time director left in early 2025 and an acting director retired soon after. George Tidmarsh was named in July 2025 and left in early November. Richard Pazdur, the agency’s veteran cancer chief, was named on 11 November and announced his retirement for the end of December. Tracy Beth Høeg became acting director in December and was out by May 2026. Around 10 September, HHS made Michael Davis the permanent director.

The biologics centre, which handles vaccines, went through similar turnover. Vinay Prasad left it for the second time in April 2026. Karim Mikhail was made permanent director in September. The agency’s chief AI officer also left in May.

The staff cuts

The churn sits on top of the 2025 cuts. HHS’s reduction in force took effect on 1 April 2025, with plans to cut about 3,500 FDA jobs. Some people were rehired, and the final number isn’t clear. The drug centre alone lost 473 staff and hired 120 in fiscal 2025.

The FDA has generally met at least 90% of its review deadlines under the prescription drug user fee programme since 2021. In 2025 some deadlines slipped. One company said in June 2025 that the FDA would miss its goal date because of heavy workload and limited resources. The agency’s public dashboard shows preliminary performance data through September 2026, but full-year on-time rates for 2025 and 2026 haven’t been published in a readable form.

PDUFA VIII

The biggest decision ahead is money. Most of the FDA’s drug review work is paid for by user fees from companies, under the Prescription Drug User Fee Act. The current law, PDUFA VII, expires at the end of September 2027. FDA and industry finished technical talks on PDUFA VIII, covering fiscal 2028 to 2032, in May 2026. A public meeting on the proposed commitments was held in September, comments are due on 16 October, and the package goes to Congress by January.

One headline term reflects the administration’s industrial policy: companies that run at least one early-stage clinical trial in the US pay half the application fee. The FDA’s deputy commissioner described “America First” as a guiding principle of the deal.

Why it matters

User fee laws are among the few must-pass health bills. Congress has reauthorised PDUFA every five years since 1992, usually with broad support, because drug reviews stop without it. That gives lawmakers a vehicle for other FDA changes in 2027.

Other drug regulators, the European Medicines Agency and Britain’s MHRA among them, also depend partly on industry fees. What stands out in the US is the leadership turnover. Approvals have held up. Whether that lasts through a new commissioner, a new user fee deal and continued staff losses is the question for 2027.