Regulatory Challenges and Antitrust Enforcement Under the Trump Administration

On April 1, 2026, a coalition of nearly 100 rare disease advocacy groups, biotech executives, and investors urged the Trump administration to restore regulatory clarity at the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER). This call for action comes as Dr. Vinay Prasad, the current head of CBER, is set to leave at the end of April following a tenure characterized by disputes over vaccine reviews and gene therapies. The coalition expressed concerns that CBER has become less flexible in overseeing clinical trials for rare diseases, leading to a significant decline in biotech investments. According to a survey conducted by the Rare Disease Biotechnology Investor Coalition, 84% of biotech investors reported reducing or pausing their investments due to recent uncertainties surrounding FDA approvals.

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The coalition highlighted a stark contrast in drug approvals, noting that CBER approved only five orphan drugs in 2025 while issuing four Complete Response Letters (CRLs) and rejecting about half of late-stage programs. In the first quarter of 2026, CBER approved just one orphan drug and issued two CRLs, compared to eight approvals at the FDA's drug evaluation center during the same period. This decline in approvals has raised alarms among stakeholders, emphasizing the need for regulatory clarity to foster investment in rare disease therapies.

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Simultaneously, the Trump administration's approach to antitrust enforcement has come under scrutiny. Following the settlement with Live Nation-Ticketmaster, former officials expressed skepticism about the administration's commitment to serious antitrust actions. Roger Alford, a former antitrust deputy, remarked that the Department of Justice (DOJ) and Federal Trade Commission (FTC) might not engage in robust enforcement for the next three years. He noted that while some Republican state attorneys general remain committed to antitrust trials, the federal landscape appears less promising.

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As federal enforcement wanes, state attorneys general are stepping in to fill the gap. A coalition of 34 state AGs, including 13 Republicans, continues to litigate against Live Nation, indicating a willingness to pursue cases that federal enforcers have opted not to. Colorado Attorney General Phil Weiser emphasized the importance of state-level enforcement as a check against perceived lawlessness at the federal level, stating, “What is happening right now is not normal, it is not acceptable, and it is dangerous.”

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The DOJ's acting antitrust chief, Omeed Assefi, defended the agency's actions against claims of undue corporate influence, asserting that lobbyists have long existed in Washington. He emphasized that while the agency engages with various stakeholders, it does not guarantee favorable outcomes. This sentiment was echoed by FTC Chair Andrew Ferguson, who dismissed the notion that lobbying affects decision-making. However, skepticism remains among former allies, who question the administration's seriousness about enforcing antitrust laws.

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• “ “What is happening right now is not normal, it is not acceptable, and it is dangerous.” — Phil Weiser, Colorado Attorney General

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• “I hope the states can bite off as much as they’re saying they’re going to and be able to chew it, but it’s challenging,” — Omeed Assefi, Acting Antitrust Chief

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The regulatory landscape under the Trump administration faces significant challenges, particularly in the realms of rare disease drug approvals and antitrust enforcement. As state AGs take on a more prominent role, the effectiveness of their efforts in the absence of robust federal support remains to be seen. The outcomes of ongoing cases, particularly against major corporations like Live Nation and potential Big Tech trials, will likely shape the future of both regulatory clarity and antitrust enforcement in the United States.

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