Makary's moment in HELP awaits

Politico

04-03-2025

Presented by
Driving the Day
MAKARY TO MAKE HILL DEBUT — Dr. Marty Makary, the Johns Hopkins surgeon who's President Donald Trump's pick to lead the FDA, will face the lawmakers standing between him and Senate confirmation on Thursday when the HELP Committee publicly vets his nomination.
There's been no shortage of pharma and public health news since Trump began his second term — and since Robert F. Kennedy Jr. took the helm of HHS. Here are the issues we expect Democrats and Republicans alike to raise with Makary:
FDA staffing: Lawmakers on the Health, Education, Labor and Pensions Committee are likely to ask Makary about FDA staffing. The medical device industry successfully pushed the Trump administration to rehire several reviewers after Elon Musk's Department of Government Efficiency fired a swath of FDA probationary employees. But the specter of further efforts to reduce the government's size hangs over health agencies.
Members might press Makary on his opinion of the FDA's user fee agreements with industry that fund nearly half the agency's work. Kennedy has championed reforming the programs, due to be renegotiated before their 2027 expiration. But the industry's payments might be difficult to replace with taxpayer funding in the current spending environment.
Vaccine science: Expect Democrats to ask Makary about vaccine safety and efficacy in light of both Kennedy's vaccine skepticism and a large measles outbreak in West Texas and single cases reported in other states. The FDA maintains some government databases around vaccine adverse events, so system oversight would be part of his mandate.
Kennedy has vowed to pursue new studies of vaccine safety after years of arguing that the products aren't adequately tested before they hit the market. But his calls for placebo-controlled studies gloss over clinical trial ethics: When testing a new vaccine, researchers should offer control groups an existing immunization if one is available.
While at Hopkins and as a Fox News contributor, Makary pushed back on Covid-19 vaccine mandates and on certain recommendations, particularly around vaccinating children. But he's avoided some of the more bombastic chatter in contrarian circles against the shots and avoided discussing Covid in his most recent book.
Advisory committees: Democrats will press Makary about his vision for the FDA's independent advisory panels, given the recent cancellation of a regularly scheduled meeting to review which strains should be included in next season's flu shot.
'We intend to use your nomination hearing next week to understand whether you support this ill-informed measure to slow critical public health decision making,' Washington Sen. Patty Murray and two other Democrats wrote to Makary on Friday.
During the pandemic, Makary slammed the FDA for bypassing the panel to authorize booster shots for teens, seemingly to avoid being contradicted by advisers who had previously declined to recommend additional doses for young people.
'This is unconscionable—undermines the integrity of the FDA's standard process!' he posted on X in January 2022.
Former Biden FDA Commissioner Dr. Robert Califf and Dr. Namandjé Bumpus, his No. 2 official, advocated for shifting how the agency uses its external advisory committees by emphasizing the groups' discussion about drug and device issues over their votes for or against formal recommendations to regulators.
IT'S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Have you sat in on Makary's murder boards in preparation for Thursday's hearing? Let us know.
Send your tips to David Lim ([e-mail] or @davidalim) and Lauren Gardner ([e-mail] or @Gardner_LM).
Eye on the FDA
MAKARY PLEDGES TO DIVEST MILLIONS IF CONFIRMED — Dr. Mark Makary said he would divest from a variety of companies, including Global Appropriateness Measures, MedRegen and telehealth and health benefits firms, if he's confirmed as FDA commissioner.
According to a financial disclosure document, GAM clients include payer lobby AHIP, Ballad Health, Booz Allen Hamilton, Devoted Health Services and Florida Health Care Plan.
The filing shows the surgeon and author will not participate in matters related to many of the companies and entities he has had a financial relationship with for a year after his potential confirmation.
But Sen. Elizabeth Warren (D-Mass.) wants Makary to recuse himself for at least four years while in office.
'Your predecessor, Dr. Califf, agreed to recuse from his former clients' specific-party matters for four years — going beyond the two-year recusal requirement in former President Biden's ethics pledge — as did over a dozen other Biden appointees,' Warren wrote to Makary in a Sunday letter. 'You should do the same.'
AROUND THE AGENCIES
HHS SPOX RESIGNS — HHS' top spokesperson has abruptly resigned after clashes over the department's management amid an intensifying measles outbreak, POLITICO's Adam Cancryn reports.
Thomas Corry, a veteran of the first Trump administration, announced on his LinkedIn page Monday that he had resigned 'effective immediately,' just two weeks after joining HHS as its assistant secretary for public affairs.
Growing disagreement with Kennedy and Stefanie Spear, one of his top advisers, prompted the departure of Corry, who was also troubled by the secretary's response to the Texas measles outbreak, according to two people familiar with the matter and granted anonymity to speak candidly.
Kennedy, a long-time vaccine skeptic, published an op-ed on Sunday on Fox News in which he emphasized personal choice around receiving vaccines and noted that 'good nutrition remains a best defense against most chronic and infectious illnesses.'
Industry Intel
ABBVIE LOOKS TO OBESITY — AbbVie entered the obesity market on Monday, announcing it has licensed a potential therapy from Danish pharma Gubra for development. The drug candidate, currently undergoing an early-stage clinical trial, targets a hormone known as amylin that promotes feelings of fullness.
Pharma Moves
Former NIH Director Dr. Monica Bertagnolli is joining Friends of Cancer Research's board of directors.
WHAT WE'RE READING
The CDC's first public statement on the West Texas measles outbreak highlighted supportive vitamin A treatment for patients — an approach commonly used in countries with high rates of deficiency — but that doesn't obviate the benefits of vaccination, NBC News reports.
The FDA has updated labeling for testosterone products after a clinical study showed no increased risk for adverse cardiovascular outcomes in men using them to treat a hormone deficiency, Reuters writes.