Despite the uncertainty currently sweeping through the Food and Drug Administration, President Donald Trump’s pick to lead the U.S. regulator has passed a final vote of confidence from the Senate with little friction.
Late Tuesday, the Senate confirmed Marty Makary, M.D., as the FDA’s new commissioner in a 56-44 vote, which saw all Republicans and three Democrats back the Trump administration’s nominee.
The Democratic lawmakers who voted in favor of the Johns Hopkins surgeon’s confirmation include Sen. Dick Durbin, D-IL, Sen. Maggie Hassan, D-NH, and Sen. Jeanne Shaheen, D-NH, The Hill reported this week.
Makary’s confirmation overlaps with that of Stanford University’s Jay Bhattacharya, M.D., Ph.D., who was voted in by the Senate 53-47 to head up the National Institutes of Health (NIH) this week.
Makary and Bhattacharya’s appointments follow Robert F. Kennedy Jr.’s ascension to the top of the Department of Health and Human Services (HHS) in February, though the appointments come at a tumultuous time for both the FDA and NIH.
At the FDA specifically, cuts under Elon Musk’s Department of Government Efficiency (DOGE) in February led to the removal of more than 1,000 probationary workers across the FDA’s device, drug and food regulation divisions. While efforts have since been made to rehire some of those lost staff members—with Reuters reporting late last month that the FDA aimed to bring back around 300 people in total—uncertainties about future layoffs continue to weigh on the agency.
Meanwhile, multiple high-profile FDA staffers, such as CDER director Patrizia Cavazzoni, M.D., and Chief Counsel Hilary Perkins, have exited the agency since the start of the year.
As for the issues Makary will be expected to tackle as commissioner, the surgeon’s Senate confirmation hearing earlier this month suggested that vaccines, advisory committees, abortion medication access and the recent rounds of health agency layoffs will be top of mind for many.
On the topic of job cuts, Makary said during the hearing that would perform an assessment of the FDA’s staffing and the agency’s ability to perform following the DOGE purge, adding that he welcomed input on inefficiencies at the FDA but also wanted to “make sure scientists and food inspectors and staff central to the core mission of the agency have all the resources they need to do their jobs well.”
Vaccines have also been a point of uncertainty under the returning Trump administration, thanks in no small part to Kennedy’s appointment as HHS Secretary. In his first address to HHS staff last month, Kennedy—who is a noted vaccine skeptic—announced a probe into the “drastic rise in chronic disease” in the U.S. focusing on childhood vaccination schedules, selective serotonin reuptake inhibitors (SSRIs), ultra-processed foods and other topics of concern.
When questioned about the ongoing measles outbreak in Texas during his hearing earlier this month, FDA’s Makary said emphatically that “vaccines save lives, and I believe that any child who dies of a vaccine-preventable illness is a tragedy in the modern era.”
On the topic of the recently canceled vaccine-related FDA advisory committee meeting, Makary did not commit to rescheduling the meeting, which was originally slated for March 13 to make recommendations for which influenza strains to be included in vaccines for the coming fall and winter flu season. Makary commented that the committee in the past has largely just “rubber-stamped” strain recommendations from the World Health Organization’s Global Influenza Program.
As for other issues raised during the hearing, Makary expressed his desire to review the FDA’s independent advisory committees more broadly to avoid possible conflicts of interest, as well as to potentially accelerate the approval pathway for generic and biosimilar drugs.
Makary was born in Liverpool, England, before moving to Baltimore, Maryland, in the U.S., where he ultimately rose through the ranks as a pancreatic surgeon at Johns Hopkins. Makary was noted for his criticism of vaccine mandates during the COVID-19 pandemic and has previously pushed back on the use of masks by kids to reduce the spread of the virus.
Makary will now be working under Kennedy alongside other health officials such as Bhattacharya at the NIH. Meanwhile, Mehmet Oz, M.D., also known by his television nom de guerre Dr. Oz, recently passed a Senate Finance Committee vote to become administrator of the Centers for Medicare & Medicaid Services (CMS). Oz’s nomination will now go before the Senate for a final vote.