Key Points
- It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively.
- The Trump administration will likely focus on drug pricing and health care costs. Enhanced subsidies for Affordable Care Act insurance plans are set to expire and unlikely to be extended by Congress.
- Health care fraud, digital health and data privacy should remain enforcement priorities.
- FDA plans to prioritize medical device cybersecurity and AI-enabled device software guidance.
- The reauthorization of OMUFA, the over-the-counter monograph drug user fee program, could serve as a platform for addressing issues like drug shortages and FDA policy changes.
Drug pricing and health care costs are likely to remain top of mind for the incoming administration. Litigation challenges to the drug price negotiation provisions of the Inflation Reduction Act (IRA) are ongoing, and, while the pharmaceutical industry has had some procedural victories in court, the Centers for Medicare and Medicaid Services have continued implementation of the IRA.
With the public and congressional focus on bringing down health care costs, we expect the new administration to remain supportive of drug price negotiation and be undeterred by the ongoing litigation.
The current focus on the overall cost of health care, however, could be in tension with the potential increase in such costs for Americans currently relying on Affordable Care Act (ACA) plan subsidies that are set to expire in 2025 and unlikely to be extended by the incoming Congress.
We anticipate that health care fraud also will remain an enforcement focus. The Food and Drug Administration (FDA) and Department of Justice (DOJ) have signaled the following as ongoing enforcement priorities:
- Clinical trial fraud.
- Cybersecurity of health information.
- Product support activities.
- Complex product referral arrangements.
Finally, we expect that digital health and data privacy will continue to draw intense scrutiny from health regulators in the foreseeable future. For example, FDA’s Center for Devices and Radiological Health intends to prioritize guidance on medical device cybersecurity and artificial intelligence-enabled device software functions for FY 2025.
HHS Secretary
If Robert F. Kennedy Jr. is confirmed as secretary of the Department of Health and Human Services (HHS), we can expect him to be a more hands-on manager of FDA issues than his predecessors. He has already staked out positions on a range of topics under FDA’s purview, including:
- Revisiting vaccine policy.
- Reexamining direct-to-consumer drug advertising.
- Loosening regulations for certain alternative therapies.
But the impact of his views remains to be seen. Among other things, while President-elect Trump’s pick for FDA commissioner, Marty Makary, has been a critic of the American “medical establishment,” he is also known to strongly value scientific evidence.
OMUFA Reauthorization
On the FDA front, there is one must-pass piece of legislation in 2025: reauthorization of the over-the-counter (OTC) monograph drug user fee program (OMUFA), which is set to expire this year. OMUFA requires the manufacturers of OTC drugs that are marketed pursuant to an OTC monograph to pay user fees to FDA.
While OMUFA reauthorization itself is likely to be uncontroversial, user fee reauthorization bills often provide a platform for other FDA-related legislation. Some issues that have received significant public and congressional focus in recent years, and therefore may be addressed via OMUFA reauthorization, include:
- Drug shortages.
- A safe harbor for “skinny labeling” preventing patent infringement litigation against generic manufacturers that carve certain indications out of FDA-approved labeling.
- Codifying FDA policy that a biosimilar can be automatically substituted for the brand without meeting a higher bar requiring that a study be done to support interchangeability.
- Expansion of FDA’s inspectional authorities, including for manufacturers of OTC monograph drugs, prompted by OTC eyedrop recalls in 2023.
- Modernization of the Dietary Supplement Health and Education Act, which would likely include requiring dietary supplements to be listed with FDA.
We also anticipate FDA will continue to pursue strategies to address the opioid epidemic under its Overdose Prevention Framework. Further, we expect FDA to continue efforts to expand the use of real-world evidence (rather than clinical trial data) to support approval of drugs and devices for rare diseases.
See the full 2025 Insights publication
This memorandum is provided by Skadden, Arps, Slate, Meagher & Flom LLP and its affiliates for educational and informational purposes only and is not intended and should not be construed as legal advice. This memorandum is considered advertising under applicable state laws.