This article is a part of Inside Year One: Key Developments Under A New Administration. Click here to read the full newsletter.
Since President Trump took office in January 2025, the life sciences sector has undergone major shifts, particularly in manufacturing, regulation, and drug pricing.
One of the most significant developments has been the push to bring drug manufacturing back to the United States. The Administration framed this as both a national security priority and an economic growth strategy. Major companies responded with unprecedented investments: Johnson & Johnson pledged more than $55 billion toward U.S. manufacturing, research and development, and technology investments; Roche announced a $50 billion commitment to domestic expansion; and Gilead Sciences committed $11 billion to supplement an already planned expenditure of $21 billion in U.S. manufacturing and R&D through 2030 to bolster its U.S. operations. This reshoring effort reflects President Trump’s broader agenda of reducing reliance on foreign supply chains, especially after vulnerabilities exposed during the COVID-19 pandemic.
Another key change has been in FDA regulation and oversight. The Trump administration has emphasized deregulation, with the goal of accelerating approvals for advanced therapies, rare
disease treatments, and biotech innovations. Some argue that streamlining the process could shorten development timelines, reduce costs, and encourage investment in cutting-edge fields, such as gene therapy and cell-based treatments. At the same time, critics across party lines caution that loosening regulatory standards may risk patient safety, create uneven access to new medicines, and place pressure on the FDA’s ability to maintain rigorous oversight. The Administration’s significant cuts to staffing levels at the FDA have exacerbated concerns over patient safety and may nullify any benefits from the streamlining process. The debate reflects a broader issue: how to balance innovation and speed with the safeguards needed to protect public health. Regardless of perspective, the Administration’s stance has already reshaped how companies allocate resources, with many pivoting toward high-risk, high-reward therapies that benefit from faster pathways.
Drug pricing policies have also disrupted the industry. In May 2025, President Trump signed an EO to lower medication costs, coupled with tariffs on imported pharmaceuticals. Deals with major companies to reduce Medicaid drug prices underscored the Administration’s approach. While these measures aimed to make medicines more affordable for Americans, they also introduced volatility into global markets, as companies recalibrated supply chains and pricing strategies. The combination of reshoring, deregulation, and pricing reforms has created a turbulent but transformative environment, positioning the U.S. life sciences sector for long-term change. Various patent reform efforts have also unfolded in 2025 alongside President Trump’s broader push to strengthen U.S. competitiveness in life sciences. These reforms are critical because intellectual property (IP) protections are the backbone of pharma and biotech innovation. As noted in our Life Sciences Industry Update from August 2025, the four main patent reform bills (RESTORE, PERA, PREVAIL, and ETHIC) have seen varying degrees of movement in Congress. PERA and PREVAIL have gained bipartisan traction and were reintroduced in both chambers in mid 2025, while RESTORE remains under debate and ETHIC continues to face industry opposition. Together, these potential reforms are shaping a new IP landscape that could strengthen patent protections and investor confidence in biotech, though the final balance between innovation and competition remains unsettled. September saw the release of the second report by the Make America Healthy Again (MAHA) Commission outlining 128 policy recommendations. Like the first report, it serves largely as a statement of policy priorities in the form of voluntary initiatives and studies, rather than enforceable regulatory actions or concrete metrics. Some of the key takeaways include proposals to
significantly restructure the Department of Health and Human Services (HHS), increased collaboration between CMS and state Medicaid, a cross-agency focus on chronic disease, and tightening the rules on direct-to-consumer (DTC) advertising of pharmaceutical products. As with any major regulatory proposals, it is far easier to propose change than it is to implement it so only time will tell what priorities move forward. Most recently, the BIOSECURE Act has continued to progress through Congress, including House and Senate consideration, as part of the FY26 National Defense Authorization Act. The annual bill would authorize a record $901 billion in national security spending next year. The BIOSECURE Act is designed to limit Chinese biotech companies and manufacturers from accessing U.S. funding and collaborating with U.S. pharma companies using federal funding. With China-based companies being responsible for 20% of drugs in development, the effect of the BIOSECURE Act will beinteresting to monitor.
Related Insights
Subscribe to Ballard Spahr Mailing Lists
Get the latest significant legal alerts, news, webinars, and insights that affect your industry.
Subscribe Copyright © 2026 by Ballard Spahr LLP.
www.ballardspahr.com
(No claim to original U.S. government material.)
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, including electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of the author and publisher.
This alert is a periodic publication of Ballard Spahr LLP and is intended to notify recipients of new developments in the law. It should not be construed as legal advice or legal opinion on any specific facts or circumstances. The contents are intended for general informational purposes only, and you are urged to consult your own attorney concerning your situation and specific legal questions you have.