On Monday, Donald J. Trump was inaugurated as the 47th U.S. president, leading many in the biotech and pharmaceutical sectors to speculate on what impacts the second Trump administration will have on their industries.
Back in December, an article in Biospace by Annalee Armstrong compiled predictions by S&P Global Market Intelligence and David Bowen of Corracloon Stategies on the administration’s approach to healthcare and federal regulation of the biopharmaceutical industry. S&P and Bowen both predicted that Trump’s pick for the Secretary of Health and Human Services, vaccine skeptic Robert F. Kennedy Jr., might try to curtail support of vaccines by the federal government, which in turn could cause large pharma companies like Pfizer and Merck to invest fewer resources into vaccine R&D.
Bowen anticipated that the outgoing Biden administration’s proposal to have Medicare and Medicaid cover GLP-1 analogues would prove politically challenging for Trump to revert due to the popularity of these drugs, while S&P questioned how the new administration would choose to approach Medicare drug price negotiations more generally, given the conflict between Trump’s promise to roll back Biden’s Inflation Reduction Act and the widespread popularity of lower medication costs for consumers.
In the wake of Trump’s inauguration, Goodwin Procter LLP, a multinational law firm, published their insights into how the Trump administration will shift federal regulation of the life sciences, with impacts ranging from antitrust policy to biosecurity legislation to the relationship between regulatory industries and judicial bodies.
Specifically, they anticipate that new legislation in the vein of the BIOSECURE Act, combined with the Trump administration’s focus on domestic manufacturing, may threaten American biotechs’ relationships not only with Chinese companies, but with international collaborators more generally. The authors of the Goodwin article caution firms to “carefully evaluate their international partnerships, supply chains, and research collaborations in light of these emerging policy positions”. They also suggest that last year’s Supreme Court decision on Loper Bright Enterprises v. Raimondo will require regulatory agencies like the FDA to obtain more explicit guidance from Congress in how the agencies interpret and implement legislation. The upshot may be that companies have more opportunities to influence the development of new regulatory frameworks.
Finally, on his first day in office, Trump issued many executive orders. Of particular note to the biopharmaceutical industry is Trump’s reversal of an earlier executive order from the Biden era that directed Medicare and Medicaid to create the Cell and Gene Therapy Access Model. This pricing model allowed the Centers for Medicare and Medicaid Services to negotiate outcomes-based agreements with pharmaceutical companies, thereby increasing access to these expensive and innovative treatments for low-income patients.