The House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies advanced the Work in Sync with Expert Review Act (WISeR Act) by a bipartisan voice vote this week, sending the measure to the full Appropriations Committee and marking the bill’s first successful legislative hurdle.

The WISeR Act would require the FDA to:

  1. Establish written standards governing how artificial intelligence tools may be used in the drug review process, including criteria for which workflow steps are permissible candidates for AI assistance;
  2. Mandate that a qualified human scientific expert reviews and formally approves any AI-generated recommendation before it can inform a regulatory decision;
  3. Publish an annual transparency report disclosing the categories of AI tools used, their developers, their validation datasets, and aggregate outcome data showing how often AI recommendations were adopted, modified, or overturned by human reviewers.

Why the 84% figure is politically salient

Proponents of the bill have cited an internal FDA analysis — first reported by the Washington Post’s Rebecca Adams on March 17, 2026 — showing that 84% of AI-assisted regulatory recommendations submitted to human reviewers during a pilot program were adopted without modification. Supporters read that figure as proof that AI is already materially influencing regulatory decisions and that binding transparency rules are overdue. Critics, including FDA staff union representatives, read it differently: a high adoption rate suggests the AI’s recommendations were accurate, making mandatory second-guessing into friction without benefit.

Context: FDA’s expanding AI use

FDA has been deploying AI tools in the Center for Drug Evaluation and Research (CDER) for literature triage, adverse-event surveillance, and structured data extraction from NDAs. The agency published a five-year AI strategy document in November 2025 that described an “AI-assisted review” framework but left implementation details to internal guidance rather than regulation. Supporters of the WISeR Act argue that internal guidance is insufficient for decisions affecting patient safety and market integrity, and that statutory requirements are needed.

The bill now proceeds to full committee markup. Its Senate companion, introduced in February 2026, has been referred to the Senate HELP Committee but has not yet received a hearing date.