The biopharma industry has been a bipartisan political target in recent years. But in the 2024 presidential election, details are scarce around key issues that could impact drugmakers.
Drug pricing has been a focal point for the Biden White House, and the next administration will either continue with negotiations under the Inflation Reduction Act or seek to go their own direction. Vice President Kamala Harris has said she wants to “accelerate” Medicare negotiations. Meanwhile, former President Donald Trump has recently embraced Robert F. Kennedy Jr., saying at a Madison Square Garden campaign event that he will let Kennedy “go wild on health.”
But the candidates’ stances on other issues pivotal to the pharmaceutical industry — such as march-in rights or FTC scrutiny — remain less clear.
Like
many Americans
, Zachary Baron, director of Georgetown University’s Center for Health Policy and the Law, has been waiting for a “big policy discussion” on some of these issues. A week before the election, he told
Endpoints News
that “it’s just not something that has really come up.”
“I would imagine that the pharma industry is probably struggling right now to understand the range of circumstances,” Baron said.
Here’s what the biopharma industry is paying attention to as Americans head to the polls:
The Inflation Reduction Act:
Harris has
championed
the IRA, which allowed Medicare to
negotiate certain drug prices
for the first time. If elected, she
has said
she’ll “cover more drugs and lower prices for Americans.” But Baron said that IRA reform could be challenging, especially if there’s a split government after the election.
However, the same applies to Trump, he added. While he would likely face pressure from the pharmaceutical industry to “slow-walk negotiated prices or kick up sand in other ways,” Baron said that “it seems to be a politically dicey move to do in your first year.” As Chris Meekins, a Raymond James research analyst and former HHS official, put it: “He’s not going to want to make it look like he is weak on the pharmaceutical industry and pharmaceutical executives.”
Trump took a similar approach to lowering drug prices in 2020, with a model that
would have
tied Medicare Part B prices to those paid by other countries. That effort was
eventually pulled
by the CMS under the Biden administration.
ATI Advisory’s Anna Kaltenboeck, who co-authored the IRA’s drug-negotiation section, said she is confident the first round of negotiated prices will take effect in 2026, barring a successful legal challenge.
“There’s a pretty solid throughline in the language that really directs what CMS has to do,” she said, noting that the law is “relatively clear” on how the prices should be implemented.
FTC scrutiny:
It’s uncertain whether Lina Khan will remain the head of the FTC, though William Blair analyst Matt Phipps said the agency’s recent challenges to deals are “at least giving people pause” when it comes to biotech M&A. JD Vance, Trump’s running mate, said earlier this year that Khan is “doing a pretty good job” during a
Bloomberg
event
. Meanwhile, Harris has
faced pressure
to replace Khan if elected.
March-in rights and drug pricing:
Under the Bayh-Dole Act of 1980, the government can — in limited circumstances — “march in” and issue new licenses for certain patents based on federally funded research. And, in February, the Biden administration rolled out draft guidance for the use of so-called march-in rights on high-priced drugs, prompting criticism from the
pharmaceutical industry
and
bipartisan lawmakers
. Phipps said he has low expectations for that actually happening, but noted it “is something that, clearly, Kamala has talked about.” Harris
released a plan
during her 2019 campaign suggesting the Bayh-Dole Act could be used to help lower drug costs, according to reports.
“If Harris wins, we could see them move in that direction. And so that’s something you
wouldn’t likely see
if Trump wins,” Meekins said. “Now, will it survive a court challenge? Probably not.”
China:
Lawyers
recently predicted
that Congress is likely to pass the Biosecure Act between the election and the inauguration in January. The legislation would essentially prohibit China-based biotech contractors from working with US companies. One of those lawyers, John Strom, told
Endpoints News
last week that both administrations would likely implement the law “in a similar fashion.”
“What you may see with the Trump administration is a willingness to move more quickly on implementation and to have that be coupled with a lot of the trade issues that they’ve focused in on,” he said.
Pharmacy benefit managers:
PBMs are a bipartisan
topic of interest
for lawmakers, and industry experts say that will likely remain the case after the election. Some lawmakers have called for
more transparency
around the so-called “middlemen” between drug manufacturers and insurers.
“I don’t think that’s going to stop being a bipartisan issue,” Kaltenboeck said. “Things like that, where there is a bit of shared ground, I would expect that to be areas of opportunity in the next Congress.”
Markets:
In early October, BMO Capital Markets analyst Evan Seigerman predicted that a Trump victory would likely be “overall more positive for the biopharma sentiment.” He said it’s likely then that the IRA would not be expanded, “FTC intervention will shift away from pharma,” corporate taxes would be lower, and the focus on drug pricing reform could shift to PBMs.
However, he added that because of the likelihood of a divided Congress, “we anticipate that there will be minimal impactful legislation affecting biopharma regardless of the president elected.”
As for the XBI — the biotech industry’s closely-watched main stock index — it could “perform well” initially if Trump is elected, but “post-initial reaction, the XBI would flatten out,” according to Jefferies’ Desh Peramunetilleke.