Key Takeaways
- FDA Commissioner Martin Makary addressed agency staff on 2 April, a day after RIF notices were sent to hundreds of employees.
- Some staff were confused by his remarks because they seemed to touch on the practice of medicine at times, which the FDA does not regulate.
- Others said Makary’s remarks on childhood obesity were ironic because much of the agency’s food, pediatrics, minority health and women’s health staff were laid off in this week's RIFs.
Commissioner Martin Makary pledged to uphold the FDA’s gold standard for science during his first address to agency staff, but his remarks led some staffers to question his understanding of the agency’s mission.
Makary spoke to employees on 2 April, one day after reduction-in-force notices were issued. Makary was sworn in on 28 March, but the agency waited until 1 April to make the announcement.
Sources told Medtech Insight sister publication the Pink Sheet that Makary received a glowing introduction from Principal Deputy Commissioner Sara Brenner, who served as acting commissioner before Makary arrived at the agency.
Makary said the country needs FDA staff and the agency’s ideas to improve the health care system. Video of the speech released by the agency shows that he also said that people need to listen to each other, recognize nuance and promote civil discourse, adding that differences of opinion among scientists are good not bad.
He said the FDA has an opportunity to usher in radical transparency, a tenet of Health and Human Services Secretary Robert F. Kennedy Jr., and facilitate more cures and meaningful diagnostics to empower people to take care of their health.
Makary added that his goal is to ensure the FDA upholds the gold standard of trusted science, transparency and common sense to rebuild public trust and advance health and safety in the US and around the world.
The speech also touched on various subjects related to chronic disease and the quality of Americans’ health, including the decline in intergenerational sperm counts.
He talked about a medical error he once made and how he apologized to the patient, with whom he ended up friends on Facebook. The anecdote was viewed as a message that FDA staff need to have humility and consider others’ opinions, sources said.
Makary’s remarks were delivered to a full room with overflow space needed to address the large crowd. The overflow room had a TV that was too small to be seen.
Another FDA source said Makary’s speech felt out of touch with a public health agency that makes population-based decisions. The staff member described the majority of his speech as filled with anecdotal stories from his career as a surgeon or his father’s career as a pharmacist that felt inappropriately targeted for the FDA since it does not regulate the practice of medicine.
“It felt like he didn’t understand the mission,” the source said.
The speech also often circled back to a focus on obesity and specifically childhood obesity, which the source found ironic because so much of the agency’s food, minority health, pediatric and women’s health staff were laid off.
Makary acknowledged that the last few days had been hard but did not mention the RIFs specifically. He also promised that staff central to the mission and operations of the agency would have the resources needed to do their job.
Spotted at the all-staff meeting was FDA Oncology Center of Excellence Director Richard Pazdur, one of the few longstanding product center heads still in place. OCE was largely spared from the RIF.
Ahead of the speech many FDA staff debated in the cafeteria the best way to register their protest with the agency cuts. Some felt not attending was best, while others chose the overflow space because reactions like “boos” were possible.
In the main room, staff were more closely monitored. If someone wanted to leave, security guards followed a person until they left to ensure there was no disruption.
