On election day, Tuesday, November 5, Americans will choose between former President Donald Trump and current Vice President Kamala Harris for their next president. The election will also see the rearrangement of Congress.
Regardless of the outcome, 63% of BioSpace readers think that this election cycle will have a substantive effect on drug prices, according to a poll conducted via LinkedIn.
In this deep dive, BioSpace takes a look at the policies and legislation that could impact the biopharma industry.
Trump Vs. Harris: IRA, Biosimilars, March-In Rights and PBMs
Kamala Harris has touted the Inflation Reduction Act as a triumph of the Biden administration, proudly advertising her tie-breaking vote on the law in the Senate. She has plans to expand the IRA’s cost-saving provisions beyond Medicare to benefit all Americans. Trump, on the other hand, could even repeal the IRA altogether, as suggested by his former advisors and others at Project 2025, and would perhaps support policies that encourage biosimilar development, to increase market competition with costly name brand drugs. In 2018, Trump signed a law that gave the Federal Trade Commission greater access to deals involving biosimilars, and since then, biosimilar approvals have been climbing.
Another area where the candidates could differ is on so-called “march-in rights,” which could be used to revoke drug patents based on federally funded research. Experts speculate that Harris might pursue march-in rights, while a potential Trump administration is unlikely to undermine the industry’s intellectual property.
Meanwhile, both Harris and Trump are expected to up the pressure on pharmacy benefit managers in a bid to reduce costs at the consumer level.
Legislative Issues on State Ballots
Also at stake in the election is the future of reproductive and women’s healthcare. After the Supreme Court overturned Roe v. Wade in June 2022, the issue of whether to allow abortion care and even IVF services was put in the hands of the states. This has created a patchwork of availability across the country and threatened women’s health research. Ten states have abortion measures on the ballot this election.
SOURCE: KFF
Meanwhile, several Republican-led states have revived a lawsuit seeking to restrict access to the abortion medication mifepristone, an issue that previously drew the ire of the biopharma industry that worried about FDA interference. A coalition of women in biotech organized an unprecedented letter campaign and submitted briefs in the legal case to push back.
But women’s health is not just a state issue. In the final weeks before the election, the Biden administration proposed a rule that would ease access to contraceptives under the Affordable Care Act. Trump has suggested he supports women’s rights and reproductive care, even calling himself the “father of IVF,” but has not provided specifics.
Beyond women’s health, Massachusetts will vote on a measure to legalize plant-based psychedelics. This could be a key issue for biopharmas that are developing drugs like MDMA and psilocybin for therapeutic use. While these therapies are advancing, developers have to contend with state and federal laws prohibiting their use, which can challenge ongoing research.
Editor‘s note: This article was originally published as a Special Edition of Biopharm Executive, BioSpace‘s weekly newsletter covering business and financial news. You can subscribe here.
