Washington, DC, Sept. 29, 2022 (GLOBE NEWSWIRE) — Today, the U.S. Senate passed the FDA Modernization Act 2.0, S.5002, unopposed, taking a major step toward adopting a policy that could drastically reduce testing on dogs, primates and other animals in the coming years. The bill, introduced by Senators Rand Paul, R-Ky. and Cory Booker, DN.J.along with 10 other cosponsors, will eliminate a federal mandate for animal testing for new drugs.
The bill also includes language from an additional reform proposal, the Animal Testing Reduction Act, drafted by Sen. Ben Ray Lujan, D-NM, to amend the Public Health Services Act to to remove the animal testing requirement for biosimilars. S. 5002 reflects the provisions of the original provision of the FDA Modernization Act approved as an amendment to an FDA legislative package taken up in June by the Senate Committee on Health, Education, Labor and pensions (HELP).
“Senate leaders from both parties recognize that the United States must lift an archaic animal testing mandate for drug development and replace that strategy with 21stmethods of the century based on human biology”, said Wayne Pacelle, president of Animal Wellness Action and the Center for a Humane Economy.
“It is the biggest political development in congressional history on the fight to replace animal testing with morally and scientifically superior methods. “”The FDA Modernization Act 2.0 will accelerate innovation and bring safer, more effective drugs to market faster by reducing red tape that is not supported by current science, and I am proud to have led load with our co-sponsors. Passing this bipartisan bill is a step toward ending the unnecessary suffering and death of animal test subjects — something I’m glad Republicans and Democrats agree needs to end.” says Dr. Paul.
Animal Wellness Action, the Center for a Humane Economy and nearly 200 organizations, medical associations, biotechnology and patient advocacy groups applaud the Senate’s passage and call on the House to pass the measure. Senators Paul and Booker introduced their original bill, S. 2952, last October. They modeled their bill on the House version of the FDA Modernization Act, HR 2565, introduced by Representatives Vern Buchanan, R-Fla.and Elaine Luria, R-Virgo., and enjoys broad bipartisan support. The U.S. House of Representatives passed its FDA user fee reauthorization legislative package in an overwhelming 392-28 vote in early June after the committee passed the measure 55-0. included the FDA Modernization Act.
This groundbreaking legislation has the potential in the years to come to reduce the use of millions of animals and provide safer and more effective medicines for patients.
“Thanks to modern scientific innovation, the use of animal toxicity testing for experimental drugs has become increasingly obsolete,” said Sen. Cory Booker, D-NJ. “This legislation will eliminate unnecessary suffering for countless animals when scientifically sound alternative testing methods become available.”
AWA and CHE thanked Senate HELP Committee President Patty Murray, D-Wash.and Ranking Member Richard Burr, RN.C., for their support of the measure. These lawmakers acknowledged that the FDA Modernization Act drew overwhelming bipartisan support in Congress.
AWA also pointed the finger 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, DN.M., and Rick Scott, R-Fla. as co-sponsors of the Paul-Booker amended bill. Senators Marco Rubio, R-Fla, Mike Lee, R-Utah and Tim Kaine, D-Virg. co-sponsored S. 2952, the original Paul-Booker FDA Modernization Act.
“We commend so many lawmakers for taking steps to bring drug development to the 21st Century and to enable innovation that will bring much-needed remedies to Americans, said Gary Michelson, MD, founder of the Michelson Center for Public Policy.”
“We are already on the verge of moving into the next phase of modern drug development, and modernizing the FDA 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 situation for people, animals and industry; and it has the potential to reduce drug costs and ease the pain of American voters at a time when inflation has driven up the cost of living for the average American family,” said Marty Irby, said Marty Irby, executive director of Animal Wellness Action, who was named one of The Hill’s Top Lobbyists for 2019-2021.
Data shows that it typically takes 10-15 years and an average investment of $1 billion and up to $6 billion for a new drug. Animal testing is not predictive of human response to drugs. This archaic process of pharmaceutical innovation slows the delivery of palliatives and treatments for patient groups, drives up drug costs, and sacrifices countless animals.
The Center for a Humane Economy, Animal Wellness Action, Animal Wellness Foundation, 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 La National Medical Association, National Hispanic Medical Association, Teva Pharmaceuticals, Emulate, Nortis Bio, Beyond Celiac, San Francisco AIDS Foundation, United Leukodystrophy Foundation, Myositis Association, SPCA International, Progressive Animal Welfare Society, and Pasado’s Safe Haven were among of the nearly 200 organizations and companies that have approved the FDA Modernization Act.
Animal welfare action is a Washington, DC-based 501(c)(4) organization whose mission is to help animals by promoting legal standards prohibiting cruelty. We champion causes that alleviate the suffering of pets, farm animals and wildlife. We advocate for policies to end dog and cockfighting and other forms of malicious cruelty and to combat factory farming and other systemic forms of animal exploitation. To prevent cruelty, we encourage good public policies and work to enforce those policies. To enact good laws, we need to elect good legislators, and that’s why we remind voters which candidates care about our problems and which don’t. We believe that helping animals helps us all.
The Animal Wellness Foundation (Foundation) is a private, charitable organization based in Los Angeles whose mission is to help animals by making veterinary care available to everyone who has a pet, regardless of economic ability. . We organize rescue efforts and medical services for dogs and cats in need and help homeless animals find a loving caregiver. We believe in bringing veterinarians to the front lines of the animal welfare movement; promote responsible pet ownership; and vaccination of animals against infectious diseases such as distemper. We also support policies that prevent animal cruelty and alleviate suffering. We believe that helping animals helps us all.
The Center for a Humane Economy is a non-profit organization that aims to influence business conduct to forge a humane economic order. The first organization of its kind in the animal welfare movement, the Center encourages businesses to honor their social responsibilities in a culture where consumers, investors and other key stakeholders abhor cruelty and environmental degradation and embrace innovation as a means to eliminate both .
Senator Rand Paul, R-Ky.
Senate Leads FDA Modernization Act