The U.S. Senate on Tuesday confirmed Johns Hopkins University surgeon Martin Makary to be commissioner of the Food and Drug Administration, giving him authority over an agency that regulates a wide swathe of the U.S. economy that includes food, tobacco, drugs and medical devices.
Three Democrats joined 53 Republicans to confirm Makary in a 56-44 vote. Sen. Bernie Sanders, the senior minority member of the Senate Health, Education, Labor and Pensions Committee, voted no.
HELP Committee Chairman Bill Cassidy, R-La., praised Makary’s confirmation, saying in a statement that his “medical background and strong vision make him more than qualified to lead the FDA.”
Makary will take the helm of an agency employing some 18,000 people under likely orders from President Donald Trump to cut the workforce while reviewing a growing number of drugs, devices and food and tobacco products. About half of the FDA’s workforce is funded through user fees such as those authorized under the Prescription Drug User Fee Act, which could complicate layoff plans.
In his confirmation hearing before the HELP committee, Makary said he wasn’t involved in the decision to lay off hundreds of FDA employees, some of whom were hired back, and indicated his evaluation of any future reductions would be independent and ensure that remaining agency workers would have all the necessary resources to do their jobs well.
John Crowley, head of the Biotechnology Innovation Organization, a powerful trade group, cautioned in an op-ed in Stat against “aggressive and often indiscriminate personnel cuts.”
Makary will also be under pressure to change the FDA’s direction on some drug regulation issues in response to guidance from Trump and new HHS Secretary Robert F. Kennedy Jr., a prominent skeptic of vaccines. Already, the agency has already faced a mini-controversy over its cancellation of a key vaccine advisory committee meeting. Direct-to-consumer drug advertising could receive renewed scrutiny, although Trump has previously failed to ban it. Trump has also raised concerns about the role of pharmaceuticals in chronic disease trends, the topic of a recent closed-door federal commission meeting.
An approval decision of a next-generation COVID-19 vaccine developed by Moderna is due by May 31. While not an outright skeptic of COVID vaccines, Makary objected to vaccine mandates during the pandemic and claimed public health officials didn’t take into account the natural immunity that many workers had from prior infections.
Other key upcoming FDA decisions include those on Gilead’s twice-yearly preventive HIV injection, a cell therapy for a rare skin disease and a gene therapy for a genetic metabolic disorder.
