Health Care Policy Update: Health Care Policy Weekly Update and Outlook

Research evidence excerpt

Health Care Policy Update: Health Care Policy Weekly Update and Outlook

Accessible version

Health Care Policy Update

Health Care Policy Weekly Update and

Outlook

Government Regulations

FDA Leadership Overhaul – Dr. Makary Resigns 18 May 2026

On May 12, FDA Commissioner Marty Makary announced his resignation. This

High Yield Creditannouncement followed several days of speculation regarding his future with the

United Statesagency. FDA announced that Kyle Diamantas would be elevated to Acting FDA

Washington HealthcareCommissioner from his Deputy Commissioner for Food position. In addition, on May 15,

it was reported that several other FDA leaders would also be departing the agency,

Table of Contentsincluding Center for Drug Evaluation and Research (CDER) Acting Director Tracy Beth

Hoeg, who will be replaced by Michael Davis. Center for Biologics Evaluation and Health Care Policy Events for the Week 2

Research (CBER) Acting Director Katherine Szarama will be replaced by Karim Mikhael,

who joined the FDA in 2025. Other FDA leadership positions were also expected to be

replaced. It is also not clear when the Trump Administration plans to announce a new Andrew B. Bressler, CFA

Research Analyst

permanent FDA Commissioner. We also note that FDA, industry, and Congress have BofAS

already begun work on User Fee Negotiations over the next year leading up to the +1 202 442 7454 andy.b.bressler@bofa.com

September 2027 deadline to pass legislation. However, Changes in FDA leadership may

have an impact on this process.

Abbreviations

CMS Announces Fraud Effort with Moratorium on New CMS: Centers for Medicare and Medicaid

Medicare Hospice and Home Health Agency Providers Services

On May 13, HHS and CMS announced a new six-month moratorium on new Medicare HHS: Health and Human Services