FDA Modernization Act 2.0

The FDA Modernization Act 2.0 (FDAMA), signed into law by President Biden in December 2022, revamps the drug approval process and promises a dramatic reduction in the use of dogs, primates, and other animals in laboratory tests. The legislation, spearheaded by Animal Wellness Action and the Center for a Humane Economy, eliminated a federal mandate for animal testing for new drugs approved by FDA that had been in place since 1938. The FDA Modernization Act also includes a provision — the Reducing Animal Testing Act — to eliminate a similar mandate for biosimilars regulated by the U.S. Public Health Service.

The positive reception to the FDA modernization Act 2.0 from the scientific and biotech communities cannot be overstated. Hardly has any legislation of a non-political nature garnered such a level of interest, so fast. More than 350 global publications, including news articles, commentaries, scientific reviews, and primary papers have emphasized the significant value the FDAMA adds to innovation in drug development.

However, there is more work to do. FDA has made deflated statements concerning the utility of the law – mostly downplaying its significance and asserting that FDAMA did not materially alter any practice at the agency. For instance, the FDA has yet to institutionalize rulemaking, the all-too-important process of implementing the policy mandates of the law or even announce a timeline for institutionalizing these changes. This includes revising the related narrative and guidance to information seekers, all of which remain unaltered across FDA channels, and therefore at odds with the law. Public and Congressional pressure on the FDA to do what is legally required will be needed moving forward.

Additionally, there is little regulatory clarity at the FDA, likely deliberate, regarding the overall process of regulatory acceptance of nonanimal New Approach Methodologies (NAMs), even with the passage of the FDAMA. This is confusing to drugmakers and to the scientific community overall. A dedicated follow-up is needed, including enforceable legislation that streamlines the process, ensures the implementation, organizes consolidated steps, and demands accountability regarding the actions, given the stultification by the agency.