FDA Commissioner pick Makary pressed by Senators on vaccines
Dr Martin Makary at Senate HELP Committee nomination hearing.
Johns Hopkins surgeon and writer Dr Martin Makary, President Donald Trump's pick to lead the FDA, faced a grilling today by the Senate Health, Education, Labor, and Pensions (HELP) committee, which focused on vaccines, the abortion pill mifepristone, and FDA job losses.
While a respected professor of surgery and health policy at Johns Hopkins, Makary is another Trump pick who has courted the media limelight and generated headlines during COVID-19 for his opposition to widespread vaccination, particularly in children.
In his opening remarks, which included effusive praise for Trump and Health and Human Services (HHS) Secretary Robert F Kennedy Jr, Makary pledged to make sure the FDA "holds to the gold standard of trusted science, transparency, and common sense to rebuild public trust and make America healthy again."
The decision by vaccine sceptic Kennedy to cancel the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on the formulation of influenza vaccines, as well as the February get-together of the Advisory Committee on Immunisation Practices (ACIP), has raised fears of anti-vaccine sentiment seeping into the FDA and other HHS agencies.
HELP chair Senator Bill Cassidy highlighted the VRBPAC decision in his questioning, asking Makary for comment on how the FDA can still benefit from the expertise of its advisors if such meetings are cancelled and whether the decisions go against Kennedy's oft-repeated pledge to increase transparency at the FDA.
Makary repeatedly said he was not involved in cancelling the meetings and promised to "take a look at" the VRBPAC decision if confirmed as FDA Commissioner. However, he also said he believed the committee was merely 'rubber stamping' the decisions made by the WHO's Global Influenza Programme (GIP) and refused to say he would reconvene the meeting.
In later testimony, he also said there was a need to review the ethics policy to ensure advisory committee members do not have a "cosy relationship" with the pharma industry – although, it's worth noting that they already have to undergo vetting for conflicts of interest.
Asked by Cassidy if he would reintroduce the in-person requirement for prescribing mifepristone – for example, rolling back the FDA's decision to make it available via mail order – Makary said he had no preconceived plans, but would take a "solid, hard look" at the data and meet with the agency's experts to look at the data coming out of the risk evaluation and mitigation strategy (REMS) programme for the drug.
That raised eyebrows among Democratic Senators Patty Murray and Tammy Baldwin, who said Makary's comments on re-evaluating the data on the drug – which has been shown to be safe and effective in decades of research – appeared to run counter to earlier assurances he had delivered to them at meetings ahead of the hearing.
Kennedy has also said that he wants to look again at the data on mifepristone, which has seen use by mail order increase in the wake of the US Supreme Court overturning the constitutional right to abortion in 2022.
The sweeping dismissal of FDA employees was also raised at the hearing, with Republican Senator Susan Collins seeking assurances that Makary himself and not some other "outside force" – likely alluding to Elon Musk's department of government efficiency – would be taking the lead on FDA staffing levels.
"If confirmed as Commissioner, you have my commitment that I will do an assessment of the staffing and personnel at the agency," he said, whilst stopping short of saying whether he would be ultimately responsible for staffing decisions.
"I want to make sure that the scientists and food inspectors and staff central to the core mission of the agency have all the resources they need to do their job well."
As with Trump's candidate to lead the NIH – Dr Jay Bhattacharya, who faced the HELP Committee yesterday – Makary seems likely to make it through the vetting process in the Republic-dominated Senate with ease. The committee is scheduled to vote on both appointments on Thursday 13th March.
