The measure, if enacted, is likely to spare millions of animals torment, deliver safer, more effective treatments and cures to patients
WASHINGTON, D.C. – The FDA Modernization Act 2.0 is included as a provision in the omnibus spending package released this morning by House and Senate negotiators, setting up the prospect of enacting the measure by the end of Friday. The FDA Modernization Act 2.0 will eliminate a federal mandate for animal testing for new drugs.
H.R. 2565 was introduced in the House in April of last year by Representatives Vern Buchanan, R-Fla., and Elaine Luria, D-Virg., with the Senate companion bill (S.2952) introduced in October 2021 by Senators Rand Paul, R-Ky., and Cory Booker, D-N.J. Both bills have broad bipartisan support. The legislation mirrors provisions of the original FDA Modernization Act provision approved as an amendment to an FDA legislative package taken up in June by the Senate Health, Education, Labor and Pensions (HELP) Committee.
The U.S. House of Representatives passed its FDA legislative package for user fee reauthorization in a landslide vote of 392 – 28 in early June after the committee passed the measure 55 – 0. That package included the FDA Modernization Act.
After riders were stripped from the final FDA user fee package, Senators Paul and Booker re-introduced the legislation as S. 5002, the FDA Modernization Act 2.0, and that measure passed the Senate by unanimous consent in late September.
“That the United States must lift an archaic animal-testing mandate for drug development and replace that strategy with 21st-century methods grounded on human biology,” said Wayne Pacelle, president of Animal Wellness Action and the Center for a Humane Economy. “Needless testing on countless beagles, endangered primates, and other animals must come to an end, especially when there are superior alternatives.”
“We are already on the verge of the next phase of modern drug development, and the FDA Modernization Act will be the catalyst for this transition to modern science,” noted Tamara Drake, director of research and regulatory policy at the Center for a Humane Economy.
Animal Wellness Action, the Center for a Humane Economy, the Michelson Center for Public Policy, PETA, Animal Protection of New Mexico, and over 200 organizations, medical associations, biotech, and patient advocacy groups have advocated for the passage of this provision since early in the 117th Congress. The legislation has the potential in the coming years to reduce the use of millions of animals and to deliver safer, more effective drugs to patients.