NABR’s press statement on the FDA Modernization Act 2.0
FOR IMMEDIATE RELEASE
Contact: Eva Maciejewski
Thursday, January 12, 2023
(202) 967-8305
The FDA Modernization Act 2.0, passed as part of the Omnibus appropriations legislation in December of 2022, amends the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) to clarify methods manufacturers and sponsors can use to investigate the safety and efficacy of a drug by inserting language on “nonclinical tests,” where “nonclinical tests ”are defined broadly as follows [1]:
· A test or study that is most likely to predict human response based on scientific evidence and occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug. Such test or study may include the following:
o Cell-based assays
o Organ chips and microphysiological systems
o Sophisticated computer modeling
o Other human biology-based test methods
o Animal tests
It is important to note that the FDA previously had the authority to allow non-animal data to be considered during safety and efficacy reviews of new drugs and previously issued guidance regarding such. Ultimately, the FDA Modernization Act 2.0 may not materially change the current drug approval process at the FDA. It does not eliminate animal testing for drugs nor does it state or imply that animal testing is unnecessary. It simply clarifies the definition of a nonclinical test or study under the Food, Drug and Cosmetics Act to include adjunct and complementary testing methods like organs-on-a-chip, micro-physiological systems and computer simulations. A spokesperson for the FDA stated on the record that the new law does not change the regulatory process for drugs[2].
The FDA states that many procedures intended to reduce animal tests are still in various stages of development[3] [4]. Adjunct and complementary tests have a purpose, but ultimately testing must progress to a whole intact, living system, including a rodent and non-rodent species during preclinical drug trials[5] [6] [7]. Not conducting animal tests, when necessary, would likely subject humans and other animals to unreasonable risks. NABR supports the use of alternative models to animal testing when scientifically feasible and when scientifically validated, and remains confident in the ability of FDA scientific reviewers to determine the best data that should be submitted in new drug applications.
The Food, Drug and Cosmetics Act was enacted in 1938 after the drug sulfanilamide, marketed for strep throat in the U.S. without human or animal research data establishing its safety or its efficacy, killed and sickened hundreds of people due to toxic levels of antifreeze it contained.[8] Additional animal research safety and efficacy data became required under the Act in 1963 to prevent incidents like the thalidomide incident in Europe and other parts of the world[9].
Animal testing followed by human clinical trials currently remains the best way to examine complex physiological, neuroanatomical, reproductive, developmental and cognitive effects of drugs to determine if they are safe and effective for market approval.
The overwhelming majority of drugs on the market today relied on safety and efficacy data from multiple animal models before being allowed to move to human clinical trials as demonstrated by the Foundation for Biomedical Research Top 25 Drugs and Animal Models study[10].
[3] https://www.fda.gov/advisory-committees/science-board-food-and-drug-administration/2022-meeting- materials-science-board-fda
[5]21CFR58, available online at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58
[6] 21CFR312, available online at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.23
[7] FDA Guidance Documents - M3 (R2) Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, available online at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073246.pdf; Direct quote: “In principle, the duration of the animal toxicity studies conducted in two mammalian species (one non rodent) should be equal to or exceed the duration of the human clinical trials up to the maximum recommended duration of the repeated-dose toxicity studies.”
[9] https://www.understandinganimalresearch.org.uk/news/sixty-years-on-the-history-of-the-thalidomide-tragedy
About the National Association for Biomedical Research
Founded in 1979, the National Association for Biomedical Research (NABR) is the only 501(c)(6) non-profit association dedicated to sound public policy for the humane use of animals in biomedical research, education, and testing. Members include more than 340 universities, medical and veterinary schools, teaching hospitals, pharmaceutical and biotechnology companies, patient groups, and academic and professional societies who rely on humane and responsible animal research to advance global human and animal health. Learn more about us at www.nabr.org.