Marty Makary earlier this month distanced himself from the recent shake-ups at the FDA, including the cancellation of its vaccines advisory committee meeting and the steep layoffs at the agency.
Marty Makary, surgeon at Johns Hopkins and a vocal critic of the Biden administration’s COVID-19 policies, has been confirmed to lead the FDA after winning the Senate’s vote on Tuesday.
As per CBS News, Makary garnered 56 affirmative votes. He won the support of all Senate Republicans and three Democrats: Dick Durbin (D-IL), Maggie Hassan (D-NH) and Jeanne Shaheen (D-NH).
Makary’s confirmation comes after he played it safe during his Senate hearing earlier this month, distancing himself from the recent layoffs and high-profile disruptions at the FDA. When pressed, Makary insisted that he had no hand in the cancellation of a Vaccine and Related Biological Products Advisory Committee meeting and told the lawmakers that the committee would be able to continue meeting under his leadership.
Makary did not commit to rescheduling the cancelled panel in particular, however, and said that he would “re-evaluate which topics deserve a convening of the advisory committee members of VRBPAC and which may not require a convening.” Without convening its panel of advisors, the FDA earlier this month released updated flu vaccine guidelines.
At the hearing, Makary likewise asserted that he had nothing to do with the layoffs at the FDA and promised that if confirmed, he would “do an assessment of the staffing and personnel at the agency.” More than a thousand employees at the FDA have been let go, of whom the agency plans to rehire around 300.
Even as he insists on keeping his distance from the current shake-ups at the FDA, analysts seem optimistic about Makary. In a March 7 note to investors, Jefferies called Makary a “public health advocate,” pointing to his support of “regulatory reform in areas such as lowering drug pricing, fostering innovation, and improving the FDA’s efficiency and independence.”
Makary could be particularly good for the rare diseases space, according to the Jefferies analysts, because he “clearly voices his support of streamlining rare disease drug development.” Specifically, Jefferies says that Makary “hopes to customize the regulatory process to the condition,” adding that he “supports FDA expedited approvals for generics, biosimilars, and rare diseases.”
Also on Tuesday, the Senate confirmed Jay Bhattacharya as head of the National Institutes of Health. Bhattacharya is a professor of health policy at Stanford University and is one of the three primary authors of the Great Barrington Declaration, which argued that pandemic restrictions did more harm than good and called for a return to normal except for the medically vulnerable.
Meanwhile, Mehmet Oz, Trump’s pick for the Centers for Medicare and Medicaid Services, cleared the Senate Finance Committee on Tuesday. His nomination will now move to a full Senate vote.
