What to expect for Makary’s FDA commissioner confirmation process

As other Trump nominees make their way through the confirmation process, FDA Commissioner-nominee MARTY MAKARY awaits a hearing date with the Senate’s Committee on Health, Education, Labor and Pensions (HELP). Here’s an overview of what to expect for Makary’s confirmation process in terms of milestones, timelines, and potential issues the Senate will seek to discuss.

MARTY MAKARY is DONALD TRUMP’s nominee for FDA Commissioner

• The FDA commissioner is appointed by the president and confirmed by the Senate. That means that the president is responsible for choosing a candidate, but that the Senate is tasked with confirming the hire through the “advice-and-consent” process [See AgencyIQ’s confirmation explainer here.].
• On Nov. 22, 2024, then President-elect DONALD TRUMP announced his selection of MARTIN “MARTY” MAKARY to be his intended nominee for FDA Commissioner in his administration. 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, and he has written multiple best-selling books on health policy, including Blind Spots, Unaccountable, and The Price We Pay. In a statement accompanying the initial announcement, 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.” [ Read AgencyIQ’s deep dive on Makary here.].
• Trump officially transmitted Makary’s nomination to the Senate on Jan. 20, where it was referred to the Committee on Health, Education, Labor and Pensions (HELP). As explained by the Congressional Research Service (CRS), the role of the committee in the nomination process is to “gather and review information about a nominee,” which typically involves a hearing to discuss the nomination. At these hearings, senators vet FDA commissioner candidates by asking about their experience with relevant issues (including experience in the medical field) and their previous work experience with the federal government, also using the opportunity to highlight what both the senators and the nominee view as top priorities for the FDA. As of Feb. 11 Makary’s HELP committee hearing had not been scheduled.
• In the interim, FDA’s new Principal Deputy Commissioner SARA BRENNER has been serving as acting commissioner. Brenner was previously a diagnostics regulator in the Center for Devices and Radiological Health (CDRH)’s diagnostics office, known as OHT7, and has also served in the White House and the Department of Health and Human Services (HHS), where she led diagnostics data efforts during the Covid-19 pandemic response. On Jan. 23, Brenner was added to the FDA Leadership Profiles webpage under the title of “Principal Deputy Commissioner and First Assistant to the Commissioner of Food and Drugs.” On Jan. 24, that was updated to “Acting Commissioner of Food and Drugs.”
• Makary will undergo ethics vetting for conflicts of interest as part of the confirmation process. FDA employees have restrictions against holding financial interests in businesses regulated by the agency, in alignment with criminal conflict of interest statutes (18 U.S.C. § 208). Prior to confirmation hearings, a nominee’s agreements and financial disclosure reports are typically made publicly available on the U.S. Office of Government Ethics (OGE) webpage. The documents outline the filer’s employment, assets, and compensations, as well as pledges to relinquish specific interests if confirmed. While AgencyIQ previously discussed Makary’s positions on the board of directors of Harrow, an ophthalmic compounding company, and as chief medical officer of Sesame, a telehealth and pharmaceutical compounding company, his profiles do not appear on the firm webpages as of Feb. 11.
• In the meantime, Trump’s nominee for Secretary of Health and Human Services (HHS), FDA’s parent department, has been progressing through his own confirmation process. ROBERT F. KENNEDY, Jr. advanced through the HELP Committee and the Senate Finance Committee and is expected to be confirmed this week; it’s standard for the HHS Secretary to be confirmed in advance of the agency heads they will supervise. As of Feb. 11, the nominees for to direct the National Institutes of Health (JAY BHATTACHARYA), and the Centers for Disease Control and Prevention (DAVE WELDON) remained in the same holding pattern as Makary.

How does Makary’s timeline compare with that of previous Commissioner nominees?

• In the past ten years, FDA commissioner nominees have had some variability in the timing of their paths to White Oak. In general, weeks to months have passed between the nomination and Senate HELP hearing, indicating that Makary is not “behind” yet. Under the first Trump administration, Scott Gottlieb was not announced as nominee until several months into the term. That said, both Trump nominees for FDA Commissioner had a relatively swift confirmation course once it got started.

What questions may Makary face from HELP?

• Republicans took control of the Senate following the 2024 elections. This gave the party an additional HELP seat, with the roster now comprised of 12 Republicans and 11 Democrats. The committee is currently chaired by Sen. BILL CASSIDY (R-La.), a gastroenterologist who cast the deciding vote to advance Kennedy’s HHS Secretary nomination to the full Senate. This followed a hearing marked by contentious interactions between Cassidy and Kennedy regarding vaccine safety [ AgencyIQ has a detailed discussion of Cassidy’s FDA-related policy portfolio here.]. The ranking member is Sen. BERNIE SANDERS (I-Vt.).
• Here are some predictions for the topics to be raised during the hearing. Historically, questioning has hit on topics such as drug pricing (over which the FDA does not have authority), opioids, misinformation, relationships with regulated industry, and emergency response. Makary is likely to face questions about vaccines, drug compounding, and how the White House’s deregulatory agenda will affect the FDA.
• Given the focus of Kennedy’s hearing, Makary will likely be pushed regarding his views on vaccine regulation. AgencyIQ has previously analyzed Makary’s remarks in this realm, most of which have related to the agency’s response to the Covid-19 pandemic. For example, in August 2022, Makary wrote that he was uncomfortable with FDA approving updated mRNA vaccines for Covid-19 without publicly available human clinical data, and later said FDA should have rejected mRNA applications based on small human datasets.
• Compounding may also prove to be an important topic during the hearing, especially in light of recent public discourse related to a Super Bowl ad for compounded weight loss drugs. In fact, Senators DICK DURBAN (D-Ill.) and ROGER MARSHALL (R-Kan.) sent a letter to the FDA highlighting concerns about the advertisements, requesting information about the agency’s ability to take enforcement action and indicating that they may seek legislative remedies to bolster FDA’s authorities regarding ads for compounded products. As mentioned above, Makary has held prominent positions in two companies that focus on pharmaceutical compounding, including one that dispenses compounded semaglutide – the active ingredient in Novo Nordisk’s Ozempic – to its customers.
• During Kennedy’s hearings, some legislators questioned him about specific FDA policies – many of which Makary is likely to be questioned about as well. During Kennedy’s nomination hearing before Senate Finance, Sen. BEN RAY LUJÁN (D-N.M.) questioned the HHS Secretary nominee about FDA’s 2024 draft Diversity Action Plan (DAP) guidance, which Kennedy verbally committed to finalizing at that time. However, after that verbal commitment by Kennedy, Trump issued an executive order (EO) directing agencies to terminate their diversity-related “action plan” policies, which led to the DAP guidance being pulled from the web. Following issuance of a Feb. 11 temporary restraining order, the draft DAP guidance has been re-instated, but its future remains uncertain. The future of FDA’s diversity-related policies is likely to be a key area of questioning for Makary at his confirmation hearings, especially in light of the directives from the White House.
• Other recent EOs, and FDA’s plan to deal with them, are also likely to come up. In particular, President Trump’s new deregulatory EO directs agencies to eliminate or rescind 10 “regulations” for every regulation issued – and notably includes policy documents such as memos, statements and guidance documents in its definition of “regulation.” As AgencyIQ has previously discussed, this policy is likely to significantly constrain the FDA, which has an ambitious policymaking agenda [ see AgencyIQ’s analysis compiling the agency’s different guidance agendas here]. Makary may face questions about how he will move forward the FDA’s policy agenda while aligning with the White House’s deregulatory agenda.

What happens after the hearing?

• Following the hearing, a committee has four options – “it may report the nomination to the Senate favorably, unfavorably, or without recommendation, or it may choose to take no action at all,” per the CRS. In short, a Senate committee can recommend confirmation, recommend rejection, not recommend confirmation, or do nothing. The first three actions are “reported” to the full Senate, ordinarily by filing paperwork with the Senate clerk. The full Senate (i.e., not the Committee) may also “discharge” a nomination where no action has been taken (an unreported nomination) from the Committee by unanimous consent. Under this process, the full Senate will remove an unreported nomination from the Committee to allow the full Senate to consider the nomination. This action requires a three-fifths majority in the Senate, usually 60 senators, to elevate the nomination for full Senate consideration.
• Confirmation in the Senate requires a simple majority; for example, Califf was last confirmed 50-46 in 2022.

Featuring previous research by Alexander Gaffney and Laura DiAngelo.

To contact the author of this item, please email Amanda Conti ( aconti@agencyiq.com).
To contact the editor of this item, please email Kari Oakes ( koakes@agencyiq.com).

Key Documents and Dates

• PN12-28 — Martin Makary — Department of Health and Human Services