The Trump Transition: What Marty Makary could mean for FDA if he’s confirmed as the next commissioner
Updated Nov 25, 2024 3:48 PM EST
Physician and public health researcher MARTY MAKARY has been officially named as President-elect DONALD TRUMP’s choice to become the next Commissioner of the FDA. AgencyIQ has an overview of Makary’s career, his FDA-related statements, and our predictions about what he might bring to the agency, if confirmed.
Editor’s note: This piece has been significantly updated following Trump’s announcement that Makary is his intended nominee for FDA Commissioner.
On Nov. 22, 2024 President-elect Donald Trump announced that he has selected Marty Makary to be his intended nominee for FDA Commissioner in his administration. Trump will still need to officially nominate Makary after he is sworn in as the 47th President of the United States in January 2025. [ Read AgencyIQ’s analysis of how the nomination and confirmation process works.]
In a statement, Trump said Makary would work to “course-correct and refocus” the FDA, which he said had “lost the trust of Americans, and has lost sight of its primary goal as a regulator.” Added Trump: “I am confident that Dr. Makary, having dedicated his career to high-quality, lower-cost care, will restore FDA to the gold standard of scientific research, and cut the bureaucratic red tape at the Agency to make sure Americans get the medical cures and treatments they deserve.”
Who is Marty Makary?
The basic biographic details: Marty Makary currently serves as a surgeon, health policy researcher and author at Johns Hopkins University in Baltimore, Maryland. His clinical background is in pancreatic islet transplant surgery – he’s chief of islet transplant surgery – and his university profile notes that he has received the “Nobility in Science Award from the National Pancreas Foundation and has been a visiting professor at over 25 medical schools.” He is also an elected member of the National Academy of Medicine (NAM),
Aside from his substantial medical CV, Makary also has an impressive background as a health communicator. He’s written several best-selling books on health policy, including Blind Spots, Unaccountable, and The Price We Pay. He is a frequent commentator on Fox News. Makary is credited by Atul Gawande, the author of the book The Checklist Manifesto – a massively influential book in health policy circles – as being a creator of one of the “checklists,” one meant to promote surgical safety, in the book’s title. He’s been asked to testify several times at Congressional hearings. He’s credited on more than 300 peer-reviewed scientific articles on PubMed. He was previously the editor-in-chief of the news publication MedPage Today.
Makary is also on boards of directors for at least two companies – positions he would need to resign to serve as Commissioner. He is an independent director on the board of Harrow, an ophthalmic compounding company, and at Sesame, a telehealth and pharmaceutical compounding company.
But what Makary doesn’t have much of is experience with the FDA. Makary does not have a record of service with the federal government (including with the FDA), and does not appear to have worked much on clinical development of any products later approved or cleared by the FDA. A review of his PubMed-listed academic publications includes two papers focused on the FDA. The first is a 2016 publication focused on “restoring the mission” of the Orphan Drug Act, the legislation that created a regulatory pathway and incentives for FDA’s review of drugs for rare diseases. Makary and his co-authors found that companies were seeking approval for some rare disease drugs, and then marketing them more extensively off-label. They proposed “reform to increase submission scrutiny, decrease benefits based on off-label use, and increase price transparency.” In a 2015 publication, Makary and his co-authors looked at “underreporting of robotic surgery complications,” relying on an analysis of FDA databases, legal records and other databases to identify surgical complications that had not been expressly reported to the FDA.
Makary’s takes on FDA actions and policy
But while Makary doesn’t have the usual experience with FDA – getting products approved, FDA-focused policy writing, or experience working for FDA – he has become a frequent critic of the agency, with particular focus on the agency’s response to the Covid-19 pandemic. However, the themes of his criticism have generally shifted over time.
Initially, Makary said FDA wasn’t making decisions quickly enough. In December 2020, Makary authored an article chiding the FDA for being too slow to authorize the initial Covid-19 vaccines, saying they were “wasting previous time” and not working hard enough to get the vaccine to approval. “The FDA has been too bureaucratic, taking too much time,” Makary told Fox News. “And I don’t know if they’re scheduling around vacation times and tee times of the reviewers, but they should turn the application around in 24 hours.” Makary also said FDA’s decision to warn doctors to temporarily stop providing Johnson & Johnson’s Covid-19 vaccine due to rare blood clot complications amounted to government “paternalism,” and wondered: “What ever happened to giving people the data and letting them make their own health decisions?” Makary also called for FDA to open access to a Covid-19 therapeutic, Merck and Ridgeback Biotherapeutics’ Lagevrio (molnupiravir), by using its Expanded Access regulations in the same way that it had for convalescent plasma (FDA did not do this).
More recently, Makary has been a critic of FDA’s approach to vaccines for a very different reason. While his initial critiques said the agency was moving too slow, his more recent critiques are that the agency moves too quickly, with insufficient evidence and without the support of key stakeholders. In April 2022, for example, Makary wrote that the agency was “shut[ing] out its own experts” for authorizing a vaccine booster without asking its Vaccines and Related Biologic Products Advisory Committee (VRBPAC) to weigh in. He pointed to the resignation of two of FDA’s top vaccine officials, MARION GRUBER and PHIL KRAUSE, as evidence that there was sufficient disagreement within the agency to merit a public discussion. In August 2022, Makary wrote that he was uncomfortable with FDA approving mRNA vaccines for Covid-19 based on no human clinical data available to the public, and later said FDA should have rejected the data.
A frequent point made by Makary is the importance of public trust in FDA’s decision-making. “Trust in public health is at an all-time low. When agencies bypass their own experts, it only reinforces the perception that health policy is driven by groupthink and politics,” Makary wrote in an April 2022 op-ed in the Wall Street Journal. In an October 2023 post on social media platform X, Makary stated that “massive disconnect and loss of public trust” in the agency was demonstrated by the limited uptake of Covid booster shots. In one particularly sharp line, Makary wrote in the New York Post in September 2023 that: “It’s time for the FDA to resume its role as a regulator and not the marketing department for Pfizer and Moderna.”
Makary has also called for reforms. In October 2021, Makary called for new leadership at the FDA. At the time, the agency was led by Acting Director JANET WOODCOCK, who for decades had served as director of FDA’s Center for Drug Evaluation and Research (CDER) before taking a leadership role during the pandemic and then stepping in as acting commissioner following the departure of STEPHEN HAHN. Makary’s argument was that the FDA was far too slow to review certain Covid-19 therapeutics, arguing that “For too long, FDA leaders have acted like a crusty librarian who gets annoyed when someone wants to borrow a book.” He argued that FDA “needs a change in culture,” and said, “It’s time for our old guard medical leaders to step aside into advisory roles and let new scientists, ones who are not afraid to speak up, take charge.” In October 2022, Makary called the agency the “most political FDA […] in U.S. history.”
While Makary hasn’t weighed in often on FDA policies other than Covid-19, he has done so on rare occasions. In December 2022, Congress passed the Consolidated Appropriations Act, 2023, which contained a massive FDA reform provision often referred to as the Food and Drug Omnibus Reform Act (FDORA). Section 3306 of the law clarified the applicability of medical device bans by clarifying that a medical device can be banned “for one or more intended uses” – in effect, if a device is banned for even one use, then it “is not a legally marketed device… when intended for such use or uses.” The provision had long been in development to allow the ban of one specific type of device, electrical stimulation devices (ESDs), which are used to prevent aggressive or self-injurious behavior. FDA had previously tried to ban these types of devices, but its regulation was overturned by the U.S. Court of Appeals for the DC Circuit in 2021. Despite the Omnibus law stretching thousands of pages, this one-page provision managed to attract considerable attention in conservative health policy circles, and Makary found himself weighing in during a Fox News segment in February 2023, where he considered the policy’s application to ivermectin. Notably, that statutory provision applies only to medical devices, not drug products like ivermectin.
In another instance, Makary seemed to indicate some level of support for an op-ed by former FDA Commissioner SCOTT GOTTLIEB, who argued that Congress “must update FDA regulations for medical AI [artificial intelligence].” Makary also touched on the topic in an interview with PragerU in which he said he believed AI “could be a tool to both detect fraud and create fraud” in scientific research.
Makary and MAHA
While Makary does not seem to be formally associated with the Make America Healthy Again (MAHA) movement, his perspectives and priorities align well. He appeared at a roundtable hearing hosted by Sen. RON JOHNSON (R-Wisc.) focused on “American Health [and] Nutrition” alongside ROBERT F. KENNEDY JR., CASEY MEANS, CALLEY MEANS, JORDAN PETERSON, and other conservative names often associated with the MAHA movement. He appeared in a PragerU interview, saying that the “greatest perpetrator of false information during the pandemic was the United States government,” outlining list of instances in which he maintained that health officials had erred during the pandemic (e.g., natural immunity, masking, covid vaccine boosters). “The data has caught up with public health officials, and they not only got it wrong, but they stuck to their guns when the data told them they were wrong.”
In both events, though, Makary made remarks regarding the focus of medicine being too much on treating the sick rather than preventing the illness in the first place – a core tenet of the MAHA movement. Makary also pointed to “seed oils, pesticides, the food supply, toxins, heavy metals” as areas ripe for more research and discussion. Later in the same interview he told the audience to “not trust pharma to fix this problem,” referring to what he refers to a practice of over-medicating children. “Is big pharma going to come in with a solution to the overmedicating problem? This is where we have to take a step back and realize that we are working for the everyday American. We are not working for the industry or the machine or the man. The ‘H’ in NIH is supposed to stand for Health. The ‘F’ in FDA is supposed to stand for Food. We’ve got to get back to the basics in health care.”
But to be clear: Despite Makary’s proximity to MAHA and his past critiques of FDA’s Covid-19 approvals, he is in favor of vaccines. In the same PragerU interview, Makary advocated for the development of a “universal flu shot” to replace annual shots – something he advocates for in his book and has mentioned in other interviews. He’s advocated for people to get vaccinated with the annual influenza vaccine. And as noted above, he previously advocated for FDA to authorize vaccines for Covid-19 more quickly – at least initially.
Thoughts on Makary’s nomination and path to confirmation
Compared to Robert Kennedy and MEHMET OZ, Trump’s intended nominee to run the Centers for Medicare and Medicaid Services (CMS), Makary seems like a generally uncontroversial choice for FDA commissioner. Makary’s background as chief of surgery at a respected academic institution is not dissimilar to some other academic researchers and medical officials who have led FDA, such as Stephen Hahn (who served as the second FDA commissioner under Trump) and Califf, the current commissioner. However, most other FDA commissioners have either had experience working in government or leading large organizations. For example, Hahn was the chief medical executive for the University of Texas MD Anderson Cancer Center. Califf was a senior executive at FDA, and previously led the Duke Clinical Research Institute. SCOTT GOTTLIEB served as a deputy commissioner and senior advisor at FDA for several years. MARGARET HAMBURG was a New York City health commissioner, while ANDREW VON ESCHENBACH was previously Director of the National Cancer Institute. In contrast, Makary does not appear to have the same government or leadership experience that recent FDA commissioners have had. Still, given the level of controversy surrounding some other likely nominees in Trump’s cabinet, Makary seems unlikely to attract much negative attention in comparison. And given the current anti-establishment mood among Republican voters lately, a lack of government or industry experience isn’t likely to be seen as a negative against Makary in a potential confirmation hearing.
What does this mean for the regulated life sciences industry? While Makary has shown through his statements and writings that’s he’s not a cheerleader for the life sciences industry, he also has indicated support for several key life sciences issues, including a focus on the treatment and prevention of chronic illnesses. Industry will likely be closely watching Makary’s confirmation hearings for any clues regarding what type of commissioner Makary would be, his intended focus areas, his thoughts on specific regulatory policies, who he might bring with him to help run the agency, and how he responds to political pressure. For example, we expect that Makary will come under pressure by some conservative legislators to restrict access to the abortion medication mifepristone, and how he intends to reform an agency he has often criticized.
A key question for both industry and Makary will be the intersection of the roles of the new FDA commissioner with Trump’s nominee for Secretary of HHS, Robert F. Kennedy Jr. Many FDA commissioners have chafed against HHS Secretaries that have tried to intervene in the FDA’s work as an independent agency, but Kennedy’s personal views on some health care topics like vaccine safety makes it more likely that he will be paying close attention to FDA’s work in these areas. This means that Makary could, if formally nominated and confirmed, come into conflict with either Kennedy, HHS leadership, or FDA’s own staff. As AgencyIQ has explained, the HHS Secretary can technically overrule any decision FDA or Makary would make, meaning the personal dynamics between Makary and HHS leadership would be essential to understand the leeway FDA has to regulate.
Another key thing to watch will be Makary’s intended working relationship with existing FDA staff. AgencyIQ has previously written about how some FDA leaders like PETER MARKS, the director of the Center for Biologics Evaluation and Research (CBER), could be targeted by the incoming administration. As the leader of the FDA center that regulates vaccines, Marks could come under pointed scrutiny or more intensive oversight from Makary as well, given that many of his social media posts criticizing the agency’s actions were related to decisions made by Marks in particular. While FDA commissioners have traditionally kept in place career staff and generally left product-level regulatory issues to review divisions, that’s not necessarily a requirement. This means that Makary could seek to enact a new order at the agency and try to clean house, ousting certain officials – especially if the Trump administration enacts promised reforms to civil service protections.
We’ll be watching closely on pharmaceutical compounding issues as well. Given that Makary is on the boards of two companies that focus on pharmaceutical compounding (Sesame and Harrow), we suspect that he has more than a passing understanding of how pharmaceutical compounding is regulated. Sesame dispenses compounded semaglutide – the active ingredient in Ozempic – to its customers at a flat rate through telehealth prescribing.
What will Makary’s focus be? Commissioners rarely get to choose what to focus on as commissioner; Rather, emergencies, crises, and external factors generally define their terms in office. Commissioner Califf’s most recent term in office was defined by food safety scandals and the need to overhaul the Human Foods Program. Commissioner Hahn’s tenure was defined by the Coronavirus pandemic. Commissioner Gottlieb was primarily focused on implementing Trump’s drug pricing blueprint, despite his personal priorities around vaping and e-cigarettes. For Makary, there is likely to be a tension between where he would prefer to focus, and where he will be forced to divert his focus. This could include a disproportionately heavy focus on food ingredient assessments, managing the impact of substantial cuts to FDA’s budget, a potential human outbreak of H5N1 avian influenza, managing shortages of medical products resulting from potential tensions between the U.S. and its trading partners, and more.
To read other articles in our Trump Transition series, please see our Table of Contents piece here.