Senate Confirms Makary as FDA Commissioner Amid Health Agency Shake-ups

The U.S. Senate has confirmed Johns Hopkins surgeon Martin Makary as the new commissioner of the Food and Drug Administration (FDA) in a 56-44 vote. The confirmation comes at a time of significant changes and controversies within the FDA and other health agencies under the Trump administration.

New Leadership at FDA and NIH

Makary's appointment coincides with other key health agency nominations moving forward. Stanford University's Jay Bhattacharya was confirmed to lead the National Institutes of Health (NIH) in a 53-47 Senate vote. These appointments follow Robert F. Kennedy Jr.'s recent ascension to Secretary of Health and Human Services (HHS).

The Senate Finance Committee has also approved Mehmet Oz's nomination to head the Centers for Medicare & Medicaid Services (CMS), with a full Senate vote pending.

FDA Faces Staffing Challenges and Policy Shifts

Makary inherits an agency grappling with recent upheaval. Over 1,000 probationary workers were cut across the FDA's device, drug, and food regulation divisions under Elon Musk's Department of Government Efficiency (DOGE) initiative. While efforts are underway to rehire approximately 300 staff members, uncertainty persists regarding future layoffs.

During his confirmation hearing, Makary pledged to assess the FDA's staffing and ensure that core personnel have the necessary resources. He also expressed interest in reviewing the agency's independent advisory committees and potentially accelerating approval pathways for generic and biosimilar drugs.

Vaccine Policies and Public Health Priorities

Makary's stance on vaccines has drawn attention, given the administration's skepticism towards current immunization practices. While not an outright vaccine skeptic, Makary objected to COVID-19 vaccine mandates during the pandemic. However, he emphasized during his hearing that "vaccines save lives" and called any child death from a vaccine-preventable illness "a tragedy in the modern era."

The new commissioner faces immediate challenges, including an ongoing measles outbreak in Texas and controversy surrounding the recent cancellation of a key vaccine advisory committee meeting. Makary did not commit to rescheduling the cancelled meeting but suggested re-evaluating which topics require advisory committee input.

As the FDA navigates these transitions, the pharmaceutical industry and public health community will be closely watching for any shifts in policy or priorities under the new leadership.