How the Trump Administration Could Reshape Regulation in the Life Sciences Sector

Based on recent policy signals and statements from incoming administration officials, a picture of potential regulatory and policy changes that could affect biotech, pharmaceutical, and medical device companies in coming months and years is emerging.

Anticipated changes span multiple regulatory fronts: a revamped approach to antitrust review at the Federal Trade Commission (FTC), continued momentum on biosecurity measures, and a fundamental rethinking of agency regulation to streamline “red tape” and accelerate patient access to innovative treatments. The Trump administration’s stated focus on “making America healthy again” suggests a broader transformation in how healthcare is delivered and regulated, with emphasis on nutrition, prevention, longevity, enhanced physician autonomy, and a more holistic approach to health to reduce the burdens of chronic disease.

While some changes may create opportunities for innovation and growth, others could pose compliance and operational challenges. Understanding these emerging dynamics will be crucial for industry stakeholders as they position themselves for success under the new administration.

The following six sections are based on discussions from a regulatory panel held on January 15 at the Goodwin + KPMG 6th Annual Symposium, which was held during the 2025 JPM Healthcare Conference.

1. Antitrust Deal Review: A Return to Orthodoxy

The FTC’s approach to antitrust review in life sciences is poised for a significant shift as we return to what could be called “antitrust orthodoxy.” With the elevation of Commissioner Andrew Ferguson to chair and the anticipated confirmation of Mark Meador as commissioner, we expect to see a more predictable, though not necessarily less rigorous, review process for industry transactions.

The reset in antitrust policy manifests in two main ways. First, the FTC is likely to return to its historical focus of seeking remedies for problematic transactions, rather than blocking deals outright. Major transactions that took place during the first Trump administration (such as the Bristol-Myers Squibb/Celgene and AbbVie/Allergan deals) may be instructive. Even with substantial divestitures required, deals with clear antitrust challenges were approved with appropriate remedies.

Second, the procedural burden on companies pursuing transactions is likely to increase. New Hart-Scott-Rodino filing requirements will call for dealmakers to provide more detailed submissions up front, including written narratives explaining why transactions don’t raise competitive concerns. This is likely to be the case even for traditionally straightforward deals such as early-stage pipeline acquisitions.

2. The BIOSECURE Act May Get a Second Wind

The BIOSECURE Act, despite Congress not passing it in the last session, is likely to reemerge in some form in this next Congress, given its strong bipartisan momentum from last term. While previous versions received broad congressional support, some legislators have called for additional due process provisions, specifically the ability for restricted companies to receive notice and appeal their designation. This suggests any new version will need to balance national security concerns with procedural fairness.

The broader implications for life sciences companies extend beyond just Chinese biotech relationships. The legislation signals a fundamental shift in how the US approaches international scientific collaboration and investment in the sector. Companies should carefully evaluate their international partnerships, supply chains, and research collaborations in light of these emerging policy positions.

These changes, coupled with the new administration’s emphasis on domestic manufacturing and production, suggest a continued reshaping of the global life sciences production landscape. The challenge ahead will be maintaining innovation and scientific progress while adapting to new restrictions on international collaboration.

3. Loper Bright Could Open Opportunities to Shape Regulation

The landmark US Supreme Court decision in Loper Bright fundamentally altered how federal agencies can interpret and implement legislation. This shift means that agencies such as the U.S. Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), and the U.S. Department of Health and Human Services may require more explicit congressional authorization in connection with agency decision-making, marking the end of four decades of broad judicial deference to the regulatory state.

This could lead to longer legislative processes but clearer regulatory frameworks, particularly related to novel technologies, payment models, and approval pathways. This new dynamic creates both challenges and opportunities. While regulatory changes may take longer to implement, companies will have more opportunities to engage in the legislative process and help shape the detailed frameworks that Congress must now provide.

4. Accelerating Access to Innovation

The Trump administration’s focus on “making America healthy again” signals significant changes in the advancement of nutrition policy and how medical technology reaches patients. One priority is to address the lag time between FDA approval and Medicare coverage for new medical devices, in which coverage decisions can take up to five years post-approval.

The potential appointment of Dr. Mehmet Oz as CMS administrator could benefit the industry given Oz’s experience as a medical innovator. Stated priorities include streamlining Medicare’s coding process, increasing transparency in local coverage determinations, and modernizing benefit categories to better accommodate digital health and advanced medical technologies.

These changes, combined with the administration’s emphasis on protecting physician autonomy in treatment decisions and expanding telehealth access, suggest a push toward faster adoption of innovative therapies while reducing bureaucratic hurdles in healthcare delivery.

Dr. Marty Makary’s likely appointment as FDA commissioner coincides with congressional discussions on agency user fee reauthorization, providing an opportune moment for new proposals to streamline product development, approvals, coverage, and access. In the more immediate term, the expected passage of funding legislation by March 14, 2025, to avert a government shutdown could serve as a vehicle for the new administration’s initial legislative proposals.

5. Drug Pricing Reform Is Likely to Continue

The Inflation Reduction Act’s (IRA) drug price negotiation program, while controversial, is likely to continue. Modifications sought by industry, such as leveling the distinction between small and large molecules and the orphan drug exception, face an uphill battle.

More significant changes may come in oversight of pharmacy benefit managers (PBMs), in which the administration could accelerate prior Trump-era reforms that the Biden administration and the IRA had previously delayed until 2032. The potential revival of Trump-era rules restricting PBM fees, combined with broader transparency initiatives, suggests a renewed focus on intermediary costs in the drug supply chain.

Drug importation policies, despite some state-level initiatives, are unlikely without major reforms. Previous attempts, including Florida’s program, have encountered significant practical challenges, particularly with Canada’s reluctance to participate in such schemes.

6. Could DOJ Take a Less Aggressive Approach to Enforcement?

In her Senate confirmation hearing, Attorney General-nominee Pam Bondi vowed to protect the constitutionality of the False Claims Act but also emphasized the need to “de-weaponize” the U.S. Department of Justice (DOJ).

It is conceivable that the new administration will review whether to keep several Biden-era DOJ policies, including the whistleblower pilot program and requirements for rapid disclosure of wrongdoing identified during corporate transactions.

*     *     *

As the life sciences industry prepares for this transition in Washington, the outlook suggests both opportunities and challenges ahead. While some changes may facilitate industry growth and innovation, others will require careful navigation. Companies that proactively prepare for these shifts while maintaining robust compliance programs will be best positioned to thrive in this evolving environment.

This informational piece, which may be considered advertising under the ethical rules of certain jurisdictions, is provided on the understanding that it does not constitute the rendering of legal advice or other professional advice by Goodwin or its lawyers. Prior results do not guarantee similar outcomes.