With less than three weeks before Americans head to the polls, the election race is heating up. It is still looking neck and neck as to whether the Democrats will hold their power under their candidate, Vice President Kamala Harris while the Republicans are hoping to push their way back into office under the helm of their candidate former President Donald Trump.
Although healthcare has not been at the centre of the agenda for either party, it has been on the minds of American citizens, with a Kaiser Family Foundation (KFF) poll reporting that about half of US adults say it is difficult to afford healthcare costs and about one in five adults (21%) say they have not filled a prescription because of the price.
At a recent media roundtable, John Barkett, managing director of global advisory firm Berkeley Research Group’s (BRG’s) Healthcare Transactions and Strategy practice, and former White House advisor, said whoever takes control of the White House will need to make real reforms to the American healthcare system.
Barkett said: “The next president is going to inherit an electorate that is still quite concerned about drug prices. If you look at recent polling, three-quarters of Americans say they need they want to see more drug price regulation. That includes large majorities of Democrats, Republicans and independents.”
Drug price reforms promised by both parties
Under the Harris administration, the Democrats are likely to “build off Biden” and concentrate on more complementary reforms to further lower drug prices, using the Inflation Reduction Act (IRA) as a cornerstone, says Barkett.
They have also pledged to accelerate Medicare drug price negotiation, but have not yet laid out the policy to support this. Think BRG predicts the party will likely support legislation to negotiate more drugs, with a potential for less time on the market and lower ceiling prices.
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Harris has also promised legislation for an insulin price cap, to offer the drug at a $35-or-less co-pay policy to non-Medicare populations. Harris has also pledged to improve access to new, high-cost therapies by implementing a Center for Medicare and Medicaid Innovation’s Cell and Gene Therapy model.
She has also pledged to support pharmacy benefit manager (PBM) reform, requiring more oversight from federal competition authorities. While US Congress is putting the blame on PBMs, branding them as ‘anticompetitive’, PBMs are blaming manufacturers for increasing pharmaceutical prices.
Meanwhile, a Trump administration would be looking to take a second pass at policies that were introduced, but did not come to fruition during his first term. These would include international reference pricing which the Trump administration introduced in November 2020, just the elections. Also known as the Most Favored Nation (MFN) rule, the 2020 version stated it would establish a mandatory seven-year demonstration to tie prices for drugs under Medicare Part B to those in lower prices in other countries. This could work well alongside IRA negotiations for Medicare, says Barkett.
“A big question when the Biden administration announced their first 10 negotiated drug prices was how they compared to prices in international countries. Some early analyses showed that those negotiated prices still weren’t as low as other countries. Could President Trump drive a harder bargain with drug manufacturers through the IRA? It’s a possibility,” Barkett said.
Hatch-Waxman reform
Another area where Harris and Trump are relatively aligned is with the Drug Price Competition and Patent Term Restoration Act, more commonly known as the Hatch-Waxman Act. Both parties propose a 180-day exclusivity reform to ban “parking” of such exclusivity.
During the Biden-Harris administration, Biden nominated Lina Khan to take on the role of chair of the Federal Trade Commission (FTC). During her appointment, she has pushed to ban non-compete agreements and filed lawsuits against healthcare companies engaging in anti-competitive practices. Trump’s Vice Presidential candidate JD Vance has been complimentary of Khan’s work in challenging certain Orange Book patents. This raises the question of whether this would be something the Republicans would be looking to change should they gain control of the White House.
There has also been recent talk about what Robert F. Kennedy Jr’s role would be in the Republican party should Trump regain power. Although his involvement in the party has not been confirmed, at a rally in Reading, Pennsylvania, Trump alluded that he could play a role. “We will make America healthy again. You know who’s going to do that? Robert F. Kennedy Jr. He’s got some good ideas,” he said at the rally. Kennedy Jr has already questioned the Prescription Drug User Fee Act in a Washington Post op-ed and is known to be an anti-vaxxer.
In 2019, the Trump administration called for pharma companies to include drug prices, if they were more than $35 a month, in TV adverts. Pharma companies hit back at this, and this policy was not successful, but Trump has not addressed if he would revisit this if he were to regain control of the White House.
Obama care would continue under a Harris administration
The Affordable Care Act (ACA), also known as Obama Care has already seen subsidies expanded until the end of 2025. It is likely that Harris likely will support extending them, says managing director of Clinical Economics practice at BRG, Patrick Dooley.
In his first term, Trump was unable to overturn Obama care and put in his own system so some experts question whether he would attempt this if he gained another term. “It is unclear if there would be an opportunity to try to repeal the ACA again, which failed previously, or to make significant changes which have the potential to undermine certain aspects of it,” said Dooley.
In regard to Medicaid access, this is also something expected to continue in its current state should Harris take control of the White House. Experts believe that as in his first term, Trump would likely try to increase work requirements, pursue potential cuts to Medicaid programmes, or even reinvigorate the idea of block grants.
Abortion rights continue to be contentious
During President Trump’s administration, the Supreme Court overturned the Roe v Wade decision that granted rights to abortion access, making access a state decision. Several predominantly Republican-led states have introduced bills banning abortion, including Alabama where performing an abortion is a Class A felony with up to 99 years in prison. Meanwhile, many Democrat-led states have introduced bills to keep access to abortion legal, such as in Colorado where the Reproductive Health Equity Act was signed into law in April 2022.
Project 2025, which is led by the conservative think tank The Heritage Foundation, outlines the policy plan if a Republican president takes over, and proposes the banning of the abortion pill, mifepristone.
“President Trump has been unequivocally clear in saying he won’t do that. There are potentially those around him who want to do that,” said Dan Troy, managing director of BRG’s health analytics practice and former Food and Drug Administration (FDA) chief counsel, during the same roundtable.
Meanwhile, Harris has already voiced that she wishes to reintroduce laws to make abortion access a constitutional right.
Artificial intelligence (AI) and medical device regulation
“Both Vice President Harris and President Trump have been focused on the supply side of AI in healthcare, focusing on initiatives to drive innovation to improve healthcare for patients, providers and payers. Vice President Harris and President Trump are optimistic about AI’s promises to help more than it hurts,” said Amy Reeder Worley, former fractional data protection officer and BRG managing director. She said there is not a major difference in both their views on AI despite the strong rhetoric.
Harris has worked closely and has become extremely familiar with the tech sector of Silicon Valley, taking the role of the White House spokesperson on AI for the Biden administration. In this role, she has working relationships with industry giants including Amazon, Anthropic, Google, Meta, Microsoft, OpenAI, and others. She will likely continue with the Biden Administration Executive Order (EO) on AI which laid out a coordinated, federal governmentwide approach toward the safe and responsible development of AI. In recent years, there have been an increasing number of pharma-AI partnerships including Gilead and Genesis, Lilly and insitro and Sanofi’s collaboration with both Formation Bio and OpenAI.
Trump has said he intends to repeal Biden’s AI order which he states, “hinders innovation” and looks to support AI development “rooted in free speech and human flourishing.”
In Biden’s premiership, there has been an increase in medical device regulations, including the FDA announcing it would start considering laboratory-developed tests as a medical device meaning they will be regulated. This has not been received well by the industry and questions have been asked about whether this will be overturned, citing the Loper-Bright case as a springboard.
During Trump’s previous term, he weakened medical device regulation by introducing a policy which proposed emergency exemptions to bring a multitude of devices to market without the necessary scientific backing. The FDA hit out about these changes, braiding them a “full frontal assault on public health”.
