On Thursday, September 29, 2022 Senate Bill 5002, “FDA Modernization Act 2.0” was both introduced in the Senate and passed by unanimous consent. Section 2 of the bill is entitled “Alternatives to Animal Testing.” The bill incorporates language based on provisions incorporated in the House of Representatives FDA User Fee reauthorization bill for human drugs (H. R. 7667) as well as language from separate Senate Bill 4288 “Reducing Animal Testing Act,” introduced in the spring, that would amend the animal testing provisions for human biologics, such as vaccines and blood-derived products. Senate Bill 5002 does not apply to drugs or biologics for animals. The bill has been sent to the House of Representatives.
Senate Bill 5002 would amend section 505(i) of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 355(i)) to:
- Substitute the term “nonclinical tests” for the current “preexisting clinical tests (including tests on animals)” in paragraph (1)(A) and for the current “animal” in paragraph (2)(B); and
- Add new Section 505(z) (21 U.S.C. 355(z)) defining “nonclinical tests” as:
a test conducted in vitro, in silico, or in chemico, or a non-human in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug, and may include animal tests, or non-animal or human biology-based test methods, such as cell-based assays, microphysiological systems, or bioprinted or computer models.
The Act would also amend Section 351(k)(2)(A)(i)(I)(bb) of the Public Health Service Act (42 U.S.C. § 262(k)(2)(A)(i)(I)(bb)) to substitute “an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc)” for the current “animal studies (including the assessment of toxicity).”
FDCA Section 505 applies to the approval and regulation of human drugs. The changes to Section 505 would not eliminate the use of animal testing in human drug approval, but would allow for other types of tests or analyses. Section 505(i)(1)(A) currently states that the Secretary of HHS may promulgate regulations governing the investigation of the safety and efficacy of human drugs via “preclinical tests (including tests on animals)” that are adequate to justify clinical trials on the drug. The Act would allow the justification to be based on non-animal testing or analyses, but animal testing could still be used for this purpose. Similarly, Section 505(i)(2)(B) provides that clinical investigations may begin following submission of “adequate information on the chemistry and manufacturing of the drug, controls available for the drug, and primary data tabulations from animal and human studies.” The Act would provide other types of tests or analyses on which the primary data tabulations could be based.
The effect of the changes to the Public Health Service Act (PHSA), which are limited to biosimilar products, is to remove the requirement for animal testing. Section 351(k)(2)(A)(i)(I)(bb) of the PHSA currently provides that an application for a biosimilar product shall include information demonstrating that the biologic is biosimilar to the reference product based on data derived from “animal studies (including the assessment of toxicity),” unless FDA deems such information to be unnecessary. The revision to that section would continue generally to require an assessment of toxicity, but that assessment could rely on or consist of either the testing described in subparagraph aa: “analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components,” or subparagraph cc: “a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product.” As it does now, FDA would, of course, determine whether such studies were appropriate in a given case. The same is true for animal studies, which we note the bill does not prohibit.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Animal Food and Drug practice.
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