How will the 2024 US election affect pharma? It all depends on who controls the House of Representatives and Senate, not who sits in the White House. The Senate will confirm or reject the President’s nominees to run critical agencies, including the FDA, and is likely to be Republican-controlled, according to two Washington insiders: Jim Davis, former member of the US House of Representatives (Florida’s 11th District – Democrat), and Thomas Reynolds, former member of Congress and House Leader (New York’s 26th and 27th districts – Republican).
It is a very tight race. Polling by the site FiveThirtyEight on 3 November had current Vice President Kamala Harris with a less than 1% lead over former President Donald Trump. Predictions are similarly tight for all 435 seats in the House of Representatives and the 34 Senate seats (out of a total 100) that are up for election on the 4 November ballot. With such slim margins, control over Congress will be determined by just a handful of seats.
At the Alliance for Regenerative Medicine’s Cell & Gene Meeting on the Mesa, a pharma industry conference in Phoenix, Arizona on 8 October, Davis and Reynolds predicted the most likely outcome of the election as a switch of power in the Senate. Currently, Democrats narrowly control the Senate while Republicans have a slim majority in the House of Representatives.
Onstage at the meeting, the two politicians also predicted a continuation of policies critical to China, including the Biosecure bill, regardless of who becomes president, and noted that Trump-era tax cuts will soon expire, which will require more policymaking from the new president.
Medicare: Harris versus Trump
Healthcare policy, which is usually a focus of presidential campaigns, has become secondary this year, as Trump focused on the economy and immigration and Harris focused on abortion and personal traits, said Reynolds. Neither candidate has shared much of a healthcare plan, although Trump has criticised the Affordable Care Act (ACA), also known as Obamacare, and Harris announced on 8 October that she would extend Medicare coverage to home health care for older people, paid for by negotiating drug discounts.
Reynolds, a former Republican Congressman, asked the audience: “Well, what's the Republican agenda? I'm not sure I understand it.” Among Republicans, there is a divide between Trump's America First policy and a more traditional approach from Mitch McConnell, Minority Leader in the Senate, plus “chaos” and “turmoil” among the narrow House Republican majority. “Due to a closely held House, factions of the Republican Party can actually say, ‘I'm not doing it’, and they can disrupt the whole process,” Reynolds said.
Who controls a divided Congress?
Reynolds noted that the very slim margins in both chambers of Congress make the outcome of the election unpredictable. Polls of the seven swing states that will determine the presidential winner are all within the margin of error. The tightness of the race means that control over the House and Senate will be determined by just a few seats.
“So I believe at the end of the day, a good day [for Republicans] might have the Senate Republicans picking up more than one or two seats and holding the House,” Reynolds said. Republicans currently have a majority of eight seats in the House of Representatives (with three vacant seats).
“On a bad day, or a good day for the Democrats, we would see it flip marginally the other way, and maybe they hold the Senate…and Harris wins. In the Senate, Republicans currently hold 49 of the 100 seats, with Democrats holding 47, and Independents four. So I do not see any mandate nor do I see any mammoth change coming as far as what the House or Senate looks like, aside from who controls it,” Reynolds said.
Blocking “extreme” nominees
In the case of a narrow Republican majority in the Senate, three Republican senators will be critical: Lisa Murkowski (Alaska), Susan Collins (Maine), and Bill Cassidy (Louisiana).
“The reason is these three Republican senators have demonstrated that they are independent thinkers and governors, particularly with respect to Donald Trump,” Reynolds said. These senators could help to confirm appointees by President Harris, or to derail some extreme choices by a second-term President Trump, he added.
An incoming president must review 4,000 political appointees, of which more than 1,000 require Senate confirmation. (The House of Representatives does not have a say, except for appointing the Vice President.)
The President nominates a cabinet, federal judges, and heads of agencies including the FDA, the Department of Health and Human Services (HHS), the Environmental Protection Agency (EPA), the Federal Trade Commission (FTC), the Securities and Exchange Commission (SEC), the Office of Science and Technology Policy (colloquially known as the Science Advisor to the President), and the Energy and Commerce Committee, which sits above the Health Subcommittee that focuses on insurance, R&D, and pharmaceuticals.
While most appointees are routinely confirmed by the Senate, some picks are rejected or strung along and not confirmed. There is even squabbling within parties. Monica Bertagnolli became Director of the National Institutes of Health in November 2023, but her Senate confirmation took months of wrangling, as Senator Bernie Sanders (Independent – Vermont) threatened to block the confirmation hearings until President Joe Biden acted on lowering drug prices.
President Biden picked 649 nominees in his administration, of which 569 have been confirmed by the Senate. A total of 80 nominees are still being considered.
The incoming president will almost certainly need to pick a new FDA Commissioner. The incumbent, Robert M Califf, was chosen by President Biden in 2022 and is expected to step down soon after the 2024 presidential election. He also served under former President Barack Obama from February 2016 to January 2017. Califf was an ex-industry pick and an academic, having previously held senior roles at health subsidiaries of Alphabet (the parent company of Google) and in the medical department of Duke University. Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), recently stepped down after nearly 15 years and will also require a replacement.
Scott Gottlieb served as FDA commissioner during the Trump years. He is a physician who had previously worked on Medicare, within the FDA, and on the Senate’s Federal Health Information Technology Policy Committee.
As for who Harris or Trump would pick as agency heads this time, it’s still unclear.
“Trump is unpredictable,” Reynolds noted. “He is looking for demonstrated loyalists to carry out whatever policies he's going to bring forward. So I suspect the transition committee will have some sort of litmus as to what that loyalty is.” He also noted the unexpected choice of former Representative and Senator Tom Price (Republican – Georgia) as HHS Secretary under former President Trump.
As for Harris, even if she wants to keep agency heads appointed by President Biden, “they’ll be worn out,” Davis commented, noting that President Biden chose people he knew from the Obama Administration.
