Insights & Events

Just a year into the fast-moving second Trump administration, various regulatory pilot programs and deregulatory initiatives are already examples of major changes at HHS and FDA that could impact litigation of FDA-approved pharmaceuticals and medical devices. Defendants’ most powerful defense in such litigations is often preemption, and the administration’s recent changes may both positively and negatively impact preemption arguments under the “clear evidence” standard first outlined in Wyeth and later refined in Albrecht. In Albrecht, the Supreme Court clarified that “clear evidence” is a two-part test that requires the drug manufacturer to establish: (1) “that [it] fully informed the FDA of the justifications for the warning required by state law”; and (2) “that the FDA, in turn, informed [it] that the FDA would not approve a change to the drug’s label to include that warning.” Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299, 303 (2019). To satisfy that standard, defendants must come forward with evidence of formal agency actions to support the position that FDA either rejected or would have rejected the warning that is purportedly necessary to protect plaintiffs bringing state law failure-to-warn claims.

There are two primary regulatory initiatives that could impact defendants’ preemption success. First, FDA accelerated reviews of new drug applications as exemplified in the Commissioner’s National Priority Voucher Pilot Program, which is an initiative FDA launched in 2025 to expedite the regulatory review of certain drug and biological product applications that align with specific U.S. national health and security priorities (e.g., for drugs manufactured in the U.S. that meet largely unmet medical needs). The program aims to reduce application review from 10-12 months to 1-2 months and also calls for enhanced communication between sponsors and FDA throughout the review process. If FDA accelerates reviews and also increases communications with sponsors, more front-loaded labeling negotiation and the production of more FDA positions on specific warnings may occur earlier in the regulatory process. Whether such communications are appropriately documented during this fast-moving approval process such that they meet the requirements of “formal agency action” satisfying the clear evidence standard will be an emerging issue. If courts deem communications sufficient, this accelerated review process could lead to more preemption wins in this narrow subset of cases.

The Trump administration’s deregulatory initiatives also potentially pose challenges for defendants asserting a preemption defense. One example is the “10-to-1” deregulatory approach that calls for cutting 10 regulations for each new regulation promulgated. This approach likely will lead to fewer guidance documents, fewer formalized labeling positions, and overall less documentation of FDA regulatory positions that could be construed by courts as clear evidence supporting preemption.

The second Trump administration appears to be changing the FDA approval landscape and new opportunities and pitfalls abound for defendants seeking to establish the all-powerful preemption defense.

— By Grant W. Hollingsworth