FDA Modernization Act Passes U.S. Senate, Premised on Achieving Major Reduction in Animal Testing

WASHINGTON, D.C. – The U.S. Senate passed the FDA Modernization Act 2.0, S.5002, without dissent, taking a major step toward enacting a policy that could dramatically reduce testing on dogs, primates, and other animals in the years ahead. The bill, introduced by Senators Rand Paul, R-Ky. and Cory Booker, D-N.J., with 10 other cosponsors, will eliminate a federal mandate for animal testing for new drugs.

The bill also includes language from an additional proposed reform, the Reducing Animal Testing Act, authored by Senator Ben Ray Lujan, D-NM, to amend the Public Health Service Act to remove the animal testing requirement for biosimilars. S. 5002 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.

“Leaders of the Senate from both parties recognize 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. “This is the biggest policy development in Congressional history on the fight to replace animal testing with morally and scientifically superior methods.”

Animal Wellness Action, the Center for a Humane Economy, and nearly 200 organizations, medical associations, biotech, and patient advocacy groups applaud Senate passage and call on the House to take up the measure. Senators Paul and Booker introduced their original bill, S. 2952, last October. They modeled their bill after the House version of the FDA Modernization Act, H.R. 2565, introduced byRepresentatives Vern Buchanan, R-Fla., and Elaine Luria, R-Virg., and has broad bipartisan support. 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.

This groundbreaking 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.

“The FDA Modernization Act 2.0 will accelerate innovation and get safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science, and I’m proud to have led the charge with our fellow cosponsors. The passage of this bipartisan bill is a step toward ending the needless suffering and death of animal test subjects – which I’m glad both Republicans and Democrats can agree needs to end,” said Dr. Paul. You can watch Senator Paul’s floor speech here.

“Thanks to modern scientific innovation, the use of animal toxicity testing for experimental drugs has become increasingly obsolete,” said Senator Cory Booker, D-NJ. “This legislation will eliminate unnecessary suffering for countless animals when scientifically reliable alternative testing methods are available.”

AWA and the CHE extended appreciation to Senate HELP Committee Chairwoman Patty Murray, D-Wash., and Ranking Member Richard Burr, R-N.C., for their support of the measure. These lawmakers recognized that the FDA Modernization Act had attracted very broad bipartisan support in the Congress.  

AWA also singled out Senators Mike Braun, R-Ind., Susan Collins, R-Maine, Angus King, I-Me., Roger Marshall, R-Kansas, Alex Padilla, D-Calif., Mike Crapo, R-Idaho Bernie Sanders, I-Vt., Tommy Tuberville, R-Ala., Ben Ray Lujan, D-N.M., and Rick Scott, R-Fla. as cosponsors of the Paul-Booker modified bill.  SenatorsMarco Rubio, R-Fla, Mike Lee, R-Utah, and Tim Kaine, D-Virg. cosponsored S. 2952, the original Paul-Booker FDA Modernization Act.

“We applaud so many lawmakers for taking action to move drug development into the 21st Century and to allow for innovation that will bring much needed cures to Americans, said Gary Michelson, M.D., Founder of the Michelson Center for Public Policy.” 

“We are already on the verge of the next phase of modern drug development, and FDA modernization 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.   

“It’s a win-win for people, animals and industry; and it has the potential reduce drug costs and ease the pain for American voters during an era where inflation has driven up the average American family’s living costs” said Marty Irby, said Marty Irby, executive director at Animal Wellness Action who was named one of The Hill’s Top Lobbyists for 2019-2021.

Data show that it typically takes 10 to 15 years and an average investment of $1 billion and up to $6 billion for a new drug. Animal tests are non-predictive of the human response to drugs. This antiquated process of pharmaceutical innovation slows delivery of palliatives and cures for patient groups, drives up drug costs, and sacrifices countless animals.

The Center for a Humane EconomyAnimal Wellness Action, the Animal Wellness Foundation, the Michelson Center for Public Policy, SPCA International, National Medical Association, Emulate Inc., PETA, Citizens for Alternatives to Animal Research and Experimentation, Phoenix Zones Initiative, the National Medical Association, the National Hispanic Medical Association, Teva Pharmaceuticals, Emulate, Nortis Bio, Beyond Celiac, the San Francisco AIDS Foundation, the United Leukodystrophy Foundation, Myositis Association, SPCA International, the Progressive Animal Welfare Society, and Pasado’s Safe Haven were among the nearly 200 organizations and businesses that endorsed the FDA Modernization Act.

Photo credit: Beagle and Capuchin monkey: Jo-Anne McArthur / We Animals Media

Center for a Humane Economy is a Washington, D.C.-based 501(c)(3) whose mission is to help animals by helping forge a more humane economic order. The first organization of its kind in the animal protection movement, the Center encourages businesses to honor their social responsibilities in a culture where consumers, investors, and other key stakeholders abhor cruelty and the degradation of the environment and embrace innovation as a means of eliminating both. The Center believes helping animals helps us all. Twitter: @TheHumaneCenter

Animal Wellness Action is a Washington, D.C.-based 501(c)(4) whose mission is to help animals by promoting laws and regulations at federal, state and local levels that forbid cruelty to all animals. The group also works to enforce existing anti-cruelty and wildlife protection laws. Animal Wellness Action believes helping animals helps us all. Twitter: @AWAction_News