Changes in FDA Drug Review Process Under the Trump Administration

Under the leadership of the Trump administration, the U.S. Food and Drug Administration (FDA) is moving away from a long-standing practice of involving outside experts in the review of new drug applications. Traditionally, advisory committees composed of independent specialists have reviewed evidence, offered recommendations, and voted on whether to approve specific medications, ensuring transparency and careful oversight. However, recent statements from FDA officials reveal an intention to diminish or eliminate these public expert panels.

George Tidmarsh, head of the FDA's Center for Drug Evaluation and Research, indicated that the agency prefers to sideline these advisory meetings, citing their redundancy and the significant workload they entail for both the FDA and pharmaceutical companies. Instead, he proposed a shift towards relying on complete review letters sent to companies when applications are rejected, which are now being made publicly available to promote transparency. He argued that these letters, which provide detailed reasons for denial, could replace the need for many individual drug advisory meetings.

This change raises concerns among former FDA officials and industry experts. They emphasize that advisory committees play a vital role in fostering transparency, allowing experts and the public to scrutinize regulatory decisions, and providing the FDA with valuable insights. Critics worry that bypassing these committees could lead to less oversight and potentially compromise public trust.

Since President Trump re-entered the White House, the number of advisory committee meetings has significantly dropped—from 22 meetings in the previous year to only seven so far. Officials claim this is part of an effort to streamline the review process, but critics see it as a move towards centralizing decision-making and reducing external accountability.

Examples such as the controversial approval of Aduhelm, an Alzheimer's drug approved despite a negative vote from its advisory committee, highlight the importance of public expert input. Experts argue that expert panels help assess the risks and benefits of drugs more thoroughly and that their opinions are integral to maintaining rigorous standards.

Advocates of transparency support public disclosure of complete response letters, believing it enhances understanding of FDA decisions. However, many still see public advisory committee meetings as essential, especially for complex or controversial drugs. They also point out that expert opinions can help improve drug evaluations and public confidence.

The ongoing shifts suggest a broader trend towards consolidating power within the FDA and reducing outside influence. While some argue these steps could make processes more efficient, critics warn they may undermine the integrity and transparency of drug regulation.

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