The Trump Transition: RFK has been nominated to lead HHS. What now?

President-elect DONALD TRUMP has announced his intent to nominate ROBERT F. KENNEDY JR. as Secretary of the Department of Health and Human Services (HHS) after he takes office. AgencyIQ has a look at what comes next for Kennedy – and the questions the life sciences industry will likely be pondering next.

• On Nov. 14, 2024, President-elect DONALD TRUMP announced his intent to nominate ROBERT F. KENNEDY JR. as his Secretary of the Department of Health and Human Services (HHS). The news, first reported by POLITICO, raises significant questions – and concerns – for the life sciences industry. As AgencyIQ has previously explained, Kennedy’s control of Trump’s health policy portfolio and HHS could be particularly disruptive for the FDA. For example, HHS has the authority to overrule FDA’s regulatory decisions, and Kennedy could even choose to interfere with the next round of user fee negotiations.
• Even as the nomination has left the health care industry stunned, there are several key points and questions that regulatory professionals in the life sciences industry should be aware of.
• There’s still a difficult road ahead for Kennedy’s confirmation. The secretary of HHS is a cabinet-level position, meaning that anyone nominated for the post must be confirmed by the full U.S. Senate before officially assuming the title and its attendant responsibilities. For Kennedy, confirmation could prove challenging. Kennedy was a candidate for President of the United States as a Democrat until this summer, when he dropped out of the race and endorsed then-candidate Trump for President. While that endorsement earned Kennedy a spot on Trump’s transition team and a pending nomination for HHS Secretary, Kennedy’s current and past positions may not be favorable to the Republican senators whose support he would need to obtain confirmation. Already, former Vice President MIKE PENCE has come out in opposition to Kennedy’s nomination, noting his past support for abortion, although notably Pence is not expected to have any role in the new administration. Kennedy’s stance on vaccines and pharmaceuticals may also rankle some Republican senators on the Health, Education, Labor and Pensions (HELP) Committee, which would be charged with reviewing Kennedy’s nomination. And while Trump has indicated that he hopes to avoid confirmation hearings in favor of recess appointments for his nominees, this approach would also be challenging and face an uphill battle, including the cooperation and support of incoming Senate Majority Leader Sen. JOHN THUNE (R-S.D.).
• Understanding Kennedy’s nomination in the context of other nominations by Trump: For his second term, Trump is not nominating the sort of candidates more typical of his first administration – individuals with resumes full of industry-friendly experience and who were known to the Republican party. Instead, Trump thus far seems to be nominating candidates who are far outside of the norms for agency leadership. These nominees – like MATT GAETZ for attorney general and PETE HEGSETH for secretary of defense – seem intended to shock or at the very least dramatically overhaul and limit the power of the agencies they would run, rather than effect modest industry-friendly reforms. It’s possible some of these nominees are meant to attract controversy and attention, which could potentially allow other nominees an easier path to confirmation. But it’s just as likely that these nominations, including Kennedy’s, are purposeful and will be the model for nominations from the incoming Trump administration. If many of these nominations are controversial, it may be difficult for groups opposed to Kennedy’s nomination to break through the political noise surrounding the confirmation process as a whole to register their displeasure with Kennedy specifically.
• What does this mean for the future nominee to lead the FDA? President-elect Trump will likely nominate a person recommended by Kennedy to head the FDA, especially given Trump’s previous statements that he planned to allow Kennedy to exert significant control over the administration’s health and medicines portfolio. This would likely result in a Kennedy-aligned nominee for FDA, potentially including individuals such as CASEY MEANS or other medical practitioners within the Make America Healthy Again (MAHA) movement or Kennedy’s Children’s Health Defense network. Kennedy has previously said he anticipates having a role “in choosing the people who can run FDA, NIH and CDC in a way that restores public health,” and that he favored Casey Means and her brother CALLEY MEANS.
• Look out for who Kennedy brings with him, too: For industry, it’s not just that Kennedy would lead HHS, but who he would bring with him to lead HHS. Department secretaries play key roles in hiring other leadership staff, senior advisors, general counsel and more. These staff are the ones actually running the agency on a day-to-day basis, and can exert extraordinary influence as they carry out the work of writing regulations, enacting policies, building out department-wide policy agenda, and generally driving change. Typically, HHS Secretaries – as with the FDA Commissioner – are kept busy addressing crises and handling political pressure, and sometimes find it difficult to find the personal capacity to accomplish all that they hoped to. For example, much of current FDA Commissioner ROBERT CALIFF’s time has been spent addressing food safety scandals, and much of former Commissioner STEPHEN HAHN’s tenure was spent addressing the Covid-19 pandemic. The leaders Kennedy plans to appoint to senior HHS positions are likely to be given at least a similar amount of rein as HHS staff in recent previous administrations.
• For industry, a reckoning: Kennedy’s nomination is a stark departure from prior leaders of HHS, and it likely means that the next FDA leader will be considerably more adversarial to the life sciences industry as well. While Kennedy’s nomination seemed a long shot a few weeks ago, he could be confirmed to the position in early 2025. Industry therefore has just weeks to a few months to determine how best to respond to this nomination – whether to fight it, what messaging to employ, what tactics to take, and even how to potentially re-prioritize development pipelines. As AgencyIQ has previously explained, there is much that the HHS Secretary can do to disrupt business as usual for the industry, including interfering with the negotiation process for the next Prescription Drug User Fee program.
• Whatever Kennedy does may be curtailed or slowed by some of the same legislation and administrative actions typically used by industry to decelerate or defeat pro-regulatory policies, such as those under the Biden administration. Companies might choose to sue HHS over future actions by Kennedy under the auspices of the Administrative Procedure Act, which prohibits regulatory actions that are deemed arbitrary and capricious. At the very least, Kennedy would need to comply with extensive regulations meant to ensure companies benefit from due process rights, and further litigation could extend the timeline for any adverse actions. And since the recent Supreme Court decision of Loper Bright v. Raimondo, which overturned the longstanding Chevron Deference standard, justices are more empowered than ever to review administrative decision-making.
• Dogged by DOGE: Kennedy’s efforts to reshape HHS and the FDA may be sharply limited by probable pending cuts to government agencies by Republicans in Congress, with an assist from the White House. As AgencyIQ recently explained, Trump’s new Department of Government Efficiency (DOGE) is seeking to eliminate trillions in federal spending. Assuming those cuts hit HHS and FDA – and based on the size of the targeted budget cuts, they would be considerable – Kennedy would find himself stymied in his stated goals of achieving more stringent FDA review of food chemicals, tighter vaccine monitoring, and ending industry funding for the FDA. However, the life sciences industry would still be negatively affected by those cuts.
• How long would Kennedy serve, if confirmed? One of the hallmarks of the first Trump administration was the extent and rapid rate of turnover among senior leaders as many were fired or resigned from service. According to the Brookings Institute, Trump’s executive turnover was 92% over his first term, with 35% of staff turning over in just the first year, and another 31% in the second. His first HHS Secretary, TOM PRICE, resigned after POLITICO reported that he had repeatedly flown on private and government planes for travel at significant cost to U.S. taxpayers. Even if confirmed, Kennedy might only find himself in office for a short period of time, given the potential chaos or conflicting agendas of a second Trump administration. Like all Cabinet officials, Kennedy serves “at the pleasure of the President,” meaning he can be fired at any time. And because his Make America Healthy Again (MAHA) movement actually clashes in some potentially significant ways with Trump’s Make America Great Again (MAGA) movement, Kennedy may be especially at risk.

To contact the author of this analysis, please email Alexander Gaffney ( agaffney@agencyiq.com).
To read other articles in our Trump Transition series, please see our Table of Contents piece here.