Trump Administration likely actions

Deep FDA Reform. Trump is not your average Republican on pharmaceutical and food oversight issues.  ‘MAHA,’ or Make America Healthy Again, became a staple of the Trump campaign message and his advisors, including Robert F. Kennedy, Jr., promised the American people that a Trump White House would look critically at vaccines, food production, and implications for safety and patient care. There has been serious distrust of the U.S. Food & Drug Administration (FDA) brewing among Trump supporters since the COVID-19 pandemic, and the base’s embrace of what were until recently outlier views about vaccine and food safety, demands a wholescale effort by the Trump administration to make systemic, foundational changes to those agencies.

NIH Reorganization. President Trump has charged his administration with making U.S. scientific and clinical research the gold standard. We can expect organizational changes at the National Institutes of Health (NIH), possibly mirroring those envisioned by House Energy & Commerce Committee Republican leadership in the 118^th Congress.  This fight will be soon; there will be pressure on House Speaker Mike Johnson to enable some of the NIH reforms as part of the FY 2025 funding bills, rather than waiting for the FY 2026 cycle. We could see NIH funding waiting in the wings while the new Trump Administration comes onboard and works quickly to reorganize the agency and reallocate funding. 

Health Technology. One of the first things that President Trump did during the COVID-19 pandemic was allow wide use of telehealth services, and the array of digital health modalities has only grown in promise since that time. We expect the Trump administration to embrace health technology, while keeping an eye on the bottom line.  In the area of health AI, review and possible rescission of several recent HHS rules, including rules to require AI developers to report on various metrics concerning AI safety and bias, may be up for discussion. We also expect wider latitude on coverage decisions for health tech tools and a more rapid pace of commercialization than we saw under the Biden administration.

Domestic Manufacturing. The issue of American manufacturing of medical device and pharmaceutical products and weakening our reliance on foreign produced product is tailor-made for the Trump administration.  USA jobs, USA jobs, USA jobs.  We fully expect the Trump administration to build upon ongoing Congressional efforts to create incentives for companies to build manufacturing facilities and create jobs here in the U.S., and to punish those health companies who choose to import product(s) or off-shore their operations in the form of tariffs and taxes.

Biosecurity. The BIOSECURE Act may be only the opening salvo of a wider effort to disrupt Chinese involvement in the U.S. biotech and biopharma industries. We are likely to see a further carry over in the form of new restraints around data transfer and information sharing with non-U.S. partners. This topic has enjoyed bipartisan support unlike any other this past Congress, and we expect the Trump Administration to take the gains made here and run with them.  Expect a major effort around the topic of biosecurity and anti-China regulations to come swiftly.

Potential congressional actions

Drug Pricing. In retrospect it is vexing why the Democrats did not trumpet their efforts to address drug pricing in the Inflation Reduction Act (IRA) more; perhaps it was because the program was already beginning to show signs of disrepair, as evidenced by a late breaking move by the Centers for Medicare & Medicaid Services (CMS) to provide funding to insurers to make up for the shortfall caused by drug price negotiations.  Nonetheless, as a political matter, unwinding the IRA’s drug pricing provisions is a politically risky move for Republicans, and many are actually in favor of lowering the price of drugs.  More likely will be changes to the IRA that allow Republicans to continue to support low costs for patients, such as technical amendments to ensure patient access to specialty therapies, and a withdrawal of resources for the agencies to defend the IRA in court.  Congress has already come together to support significant reform to pharmaceutical benefit managers (PBMs) and we expect that work to continue to proceed towards passage in 2025, if not sooner.

Patient Access to Low Cost Healthcare. Even though no serious health policy wonk expects a focus on repeal of the Affordable Care Act (ACA) in the next Congress, there is consensus that certain aspects of the ACA, namely, efforts to curb Medicare & Medicaid fraud, ensure adequate provider payment, and shore up insurance exchanges, may require further Congressional intervention. At the same time, Republicans do not want to touch ACA protections for pre-existing conditions and coverage for young adult family members. Likewise, we can expect that the Republican Congress & Trump administration will return to its roots of buttressing health savings accounts, supporting value-based care models that yield financial savings, and other measures that allow patient consumers to manage their own costs.

Medicare Advantage. MA is not the darling of the conservatives that it once was, and we do not anticipate the new Congress letting up on its ongoing concern concerning AI-enabled prior authorization and the expanding share of the budget that plans present. However, we do see a lessening of hand wringing around competition and efforts to support plans that provide a free-market, value based approach to patient care.

Authored by Cybil Roehrenbeck.