- with Senior Company Executives and HR
- with readers working within the Pharmaceuticals & BioTech industries
Every so often, a moment occurs that shifts the tectonic plates of an industry.
In 2010, the Obama Administration largely disrupted the healthcare industry with its landmark legislation, the Affordable Care Act. We are in another such moment, where the Trump Administration is transforming the life sciences industry, not through legislation, but through regulation. Two different methods to achieve the same result: enact significant change. The way in which the Food and Drug Administration (FDA) is regulating life sciences products and enforcing the Food, Drug and Cosmetic Act is altering the foundation of the industry. We would be remiss not to recognize the significance of the moment.
We're seeing real shifts at the FDA—not just in terms of new faces at the top, but also in the direction and speed of regulatory priorities. These changes reach far beyond the Agency's walls, influencing everything from the speed of product approvals to the intensity of enforcement actions.
The two drivers of this change are the Make America Great Again (MAGA) and the Make America Healthy Again (MAHA) movements. MAGA is pushing a deregulation agenda while MAHA is reevaluating everything from the safety and efficacy standards to over-the-counter use. These two movements are making marks across the entire industry, as policies increasingly collide in areas like tariffs, drug pricing negotiations and the implications of initiatives such as "TrumpRx."
To be sure, 2026 will be a year of realignment for how life sciences companies get their products approved and consequently operate. The Commissioner's new National Priority Voucher Program is being watched as a bellwether—what's working, what's not and how it might evolve. Also, much talk has been made about reassessing the approval process itself—with the FDA indicating openness to Bayesian statistics or defaulting to a one randomized control trial standard instead of two.
On the enforcement side of the house, we have seen an uptick in FDA activity, with companies facing a heightened risk of untitled and warning letters, as well as cease and desist demands. This enforcement underscores a renewed focus on compliance, signaling that companies must maintain robust internal protocols and be ready to respond quickly to enforcement actions that can have immediate operational—and reputational—impact.
Against this backdrop, innovation powers ahead— especially with the impact of AI for both how the FDA and industry use it. We're watching closely as AI drives new tools and therapies, even as AI raises novel questions about oversight, liability and intellectual property rights. Digital health technologies and telehealth platforms that skyrocketed in popularity during the pandemic remain squarely in regulators' sights, with federal and state authorities updating their approaches to direct-to-consumer advertising and purchasing as well as patient privacy.
In this year's "Top-of-Mind Issues for Life Sciences Companies" publication, our team unpacks these developments and offers practical insights to help your business anticipate, adapt and thrive. The goal is to equip you with the most up-to-date perspectives and legal strategies, so you can navigate the unique challenges—and seize the emerging opportunities—in the year ahead. As always, we invite you to reach out to us for deeper guidance tailored to your specific goals and concerns as we all prepare for a dynamic year in the life sciences sector.
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