FDA Addresses Industry Feedback on NAMs Guidance, CNPV Program, and NDC Rule

The FDA is facing significant industry feedback on three separate regulatory initiatives: draft guidance for using new approach methodologies to reduce animal testing, the Commissioner's National Priority Voucher pilot program, and a proposed rule to update the National Drug Code format.

In March 2026, the FDA issued draft guidance titled "General Considerations for the Use of New Approach Methodologies (NAMs) in Drug Development" to help pharmaceutical companies reduce their reliance on animal studies. NAMs include in vitro assays, cell culture systems, and computational modeling that can better predict outcomes in humans. The draft guidance builds on the FDA's April 2025 Roadmap to Reducing Animal Testing in Preclinical Safety Studies. The FDA noted that NAMs do not necessarily need to be validated to be considered for regulatory review, though validation establishes accuracy, reliability, and relevance. The Physicians Committee submitted public comments recommending targeted revisions, emphasizing that validation should not delay use of fit-for-purpose NAMs and that comparisons to animal studies should be guided by human relevance.

Separately, the FDA convened a public hearing on its Commissioner's National Priority Voucher (CNPV) pilot program, which provides recipients with more frequent access to FDA officials, shortened review times from 10-12 months to just 1-2 months, and potential eligibility for accelerated approval. The program sits alongside but does not replace other expedited review pathways. Stakeholders, including Johnson & Johnson and Merck, described the review process as highly collaborative, but others raised concerns about transparency, predictability, and politicization. Suggestions included expanding the program to cover chronic progressive diseases and establishing clear eligibility criteria through notice and comment rulemaking.

Additionally, pharmaceutical industry groups and 39 drugmakers are pressuring the FDA to finalize its proposed rule updating the National Drug Code (NDC) format by the end of March 2026. The NDC, used by virtually every system in healthcare, currently has a 10-digit format, and the FDA anticipates exhausting available labeler codes by 2032. A letter to the FDA warned that if the new 12-digit format and system updates are not operational by 2032, medication delivery could face significant disruptions. Novartis noted that implementing the NDC changes requires substantial lead time, with companies needing at least five full years to update labeling and systems.

These initiatives reflect the FDA's ongoing efforts to modernize regulatory processes, with industry stakeholders urging timely finalization and clear guidance to ensure patient access and drug development efficiency.