There is a paradox at the heart of covering this election: policy information about the two candidates is both more and less available than ever before. On the one hand, both candidates have already been associated with presidential administrations, so there’s concrete data about what they did and didn’t do while in office. On the other hand, campaigns have been less specific about their policy platforms this year than ever before, leading to the label that this is a “vibes election”.

This vagueness is definitely a double-edged sword: Trump’s lack of a defined policy platform has made it easier for his opponents to tie him to Project 2025, an extremely detailed - and extremely right-wing - policy platform created by a third-party group. But, Trump has disavowed the project as having anything to do with his campaign.

And when it comes to Harris, while the Trump campaign would like to tie her to the Biden administration, the fact is that Vice Presidents don’t have a lot of control over policy, so it’s not reasonable to assume her positions and priorities will be identical to the current President’s – though they’re more likely than not to be directionally aligned. 

Finally, there’s one more thing that needs to be said upfront: as much importance as we place on presidential administrations, a President without a Congressional majority can’t usually get much policy passed. And while it’s possible that one party could secure a majority in both houses, it’s not at all the most likely outcome. On the other hand, recent history suggests that pharma-related topics like drug pricing are one of the few areas where bipartisan legislation is still possible. 

President Biden’s passage of the Inflation Reduction Act, which, among many other provisions, allowed Medicare to negotiate drug prices for the first time and set a $35-per-month out-of-pocket cap for insulin, was a big win for the President and a big problem for pharma, which has consistently decried the law for an expected negative impact on innovation.

That’s one piece of Biden lore that Harris and running mate Tim Walz have not tried to distance themselves from – on the contrary, it’s been namechecked in both Presidential debates and is a common talking point on the campaign trail. Harris herself cast the tie-breaking vote to pass the IRA in the Senate.

Harris and Walz want to take the IRA further, expanding those out-of-pocket caps to those with private insurance.

Does Trump support the IRA? It’s not entirely clear. While he hasn't outright committed to undoing drug pricing changes, he has vowed to rescind unspent IRA funds. Project 2025 also lays out instructions for dismantling the IRA, but, again, that may not represent Trump’s thinking. Meanwhile, Trump’s record appears to support lower drug pricing, but it’s more rhetoric than record. A handful of executive orders attempting to force drug companies to match US prices to those in other countries didn’t really amount to anything – it was stymied by the courts and then rescinded by the Biden administration.

“We saw with Trump a number of policies, executive orders, I should say, that were introduced, but nothing was actually implemented when it came to lowering drug prices. There was a lot of language about how pharma was getting away with murder, for example,” Merith Basey, executive director of Patients for Affordable Drugs Now, told pharmaphorum. “But in terms of delivering for people who were struggling with high prices, we didn’t see anything. In that regard. I think with the Biden-Harris administration, we’ve seen a president who is the strongest President in history to really stand up to the power of pharmaceutical corporations.”

Trump’s basic talking point – a favoured nations policy that would bring drug pricing in line with other countries – is popular, and both parties have expressed support for it. But, it’s challenging to implement for a number of reasons, and Trump actually backed off the position via a campaign spokesperson in October.

The bottom line? Both candidates have consistently talked about lowering drug prices, but Harris and the Democrats have put a lot more money where their mouths are. But lower drug prices are broadly popular and political winners, so there isn’t a lot of political upside for Trump to dismantle the IRA now that it’s in place.

“From the pharma perspective around prescription drug policies, there isn’t likely to be a lot of significant differences,” Haile Dagne, director of policy and reimbursement at GSK, said at LSX in Boston in September. “Maybe around the edges, Trump’s probably going to have more transparency around prices and the way the Medicare negotiation programme operates. Harris will likely continue more of the same.”

One thing the President can do is appoint leaders of executive branch posts – that includes the CDC, the FDA, the FTC, the NIH, and more.

In his first term, Trump received criticism for a number of executive appointments, but his pick of Scott Gottlieb as FDA commissioner was an exception. Gottlieb was widely seen as a strong and successful pick who sped up approvals for generics and biosimilars and wasn’t afraid to go after tobacco and opioid companies. 

Biden’s choice to call back up Obama’s FDA Commissioner Robert Califf was also seen as a safe and “steady hand” for the agency.

Generally, industry insiders say the FDA has managed to stay above the partisan fray over the years, with a good deal of continuity. 

“I don’t know if the election’s going to have a terrible impact on the regulatory pathways,” Digital Therapeutics Alliance CEO Andy Molnar said during a panel at LSX. “…The FDA is really forward-thinking already.”

But, if the FDA has proven fairly insensitive to political shifts, the same cannot be said of the Federal Trade Commission. Under Biden’s Chairwoman Lina Khan, the agency has been aggressive in its sceptical posture toward big pharma mergers, its challenges to pharma patents, and its recent lawsuit against pharmacy benefit managers. 

It’s possible the Trump administration will behave similarly or even keep Khan on – prior to being chosen as VP, JD Vance did express support for her work regulating big tech. And Trump did sign a law in 2018 strengthening the FTC’s hand in regulating biosimilars. 

However, Trump’s 2017 FTC was considerably less aggressive than the current incarnation, so pharma can hope for a return to form. 

Of course, there are many other issues touching the pharmaceutical industry over which the next US President will have power.

Vice President JD Vance has made the opioid epidemic in America a major cause since he first entered public life with his hit memoir Hillbilly Elegy. He emphasised his personal history with opioid addiction in his family during his nomination acceptance speech.

“Things did not work out well for a lot of kids I grew up with,” he said. “Every now and then, I will get a call from a relative back home who asks, 'Did you know so and so?' And I’ll remember a face from years ago. And then I’ll hear, ‘They died of an overdose.’ As always, America’s ruling class wrote the checks; communities like mine paid the price.”

But Vance’s track record on opioids is complicated. His non-profit, founded to help combat the crisis, Our Ohio Renewal, did little to address the opioid crisis and eventually closed down amid accusations of ties to big pharma. And on the campaign trail, Vance and Trump have mostly used fentanyl as a talking point in conversations about immigration and border security.

Harris’s campaign website does include a passage on opioids and fentanyl, pointing to Harris’s history as a prosecutor as well as the accomplishments of the Biden-Harris administration. 

“In the White House, she helped direct more than $150 billion to disrupt the flow of illicit drugs and delivered billions of dollars in investments to states to fund lifesaving programmes,” the website says. “Under the Biden-Harris Administration, the FDA made the overdose-reversal drug naloxone available over-the-counter. This past year, the number of overdose deaths in the United States declined for the first time in five years. As President, she will sign the bipartisan border bill that will fund detection technology to intercept even more illicit drugs, and she’ll keep fighting to end the opioid epidemic.”

Abortion is a major issue this election cycle, and pharma was pulled into it last year when abortion detractors successfully sued in a lower court to reverse the FDA’s longstanding approval of the abortion drug mifepristone. Ultimately, the Supreme Court ruled to strike the decision and support the FDA’s decision.

That suit was opposed by the pharma industry for the precedent it could have created in undermining the FDA’s gatekeeper role in approval decisions for medicines.

Democrats have made protecting abortion access a major pillar of their platform this election cycle, while Republicans have avoided the issue where possible and placed their emphasis on the right of states to decide the matter independently.

But when it comes to mifepristone, there’s no disagreement – Trump said in the first presidential debate that he agreed with the Supreme Court’s decision and would not block it.