By: Marty Irby, Guest Writer
Last night a legislative action that has the potential to prevent the use of millions of animals and deliver safer, more effective drugs to countless patients in need of treatments, overwhelmingly passed the U.S. House of Representatives. The FDA Modernization Act, as a rider to a larger package of FDA-related reforms, cleared the House thanks to the leadership of U.S. Reps. Nancy Mace, R-Charleston, Buddy Carter, R-Savannah, and others. The Senate Health, Education, Labor and Pensions Committee has released its own FDA reform package, and that measure also includes the FDA Modernization Act language led by U.S. Senator Rand Paul, R-Kentucky, in the Upper Chamber.
Republicans and Democrats united to pass the FDA Modernization Act, H.R. 2565 and S. 2952, to reform our drug approval process and to drive the use of non-animal testing methods. Addressing the category of testing that runs through the largest number of animals, the FDA Modernization Act is included as Section 701 in a legislative package known as the Food and Drug Amendments of 2022, H.R. 7667. The vote on H.R. 7667 last night was 392 to 28.
“Securing House passage of legislation led by Republicans in a Congress when Democrats have the majority in both chambers is a herculean feat during this challenging political climate and we applaud Reps. Nancy Mace and Buddy Carter for their heroic work,” said Marty Irby, executive director at Animal Wellness Action. “The FDA Modernization Act will rollback an outdated burdensome federal mandate that unnecessarily harms animals, and increases both drug prices, and time to market.”
“The passage of the FDA Modernization Act today is a significant step forward for not only the animal welfare community but researchers who have been forced for decades to rely on antiquated, burdensome animal testing mandates,” said Rep. Nancy Mace, R-S.C., one of the authors of the FDA Modernization Act. “I look forward to this landmark legislation being signed into law to reduce waste, save animals’ lives, and streamline potential lifesaving medication for patients.”
“As a pharmacist, I know we can do better on drug pricing, delivery times to patients by improving both safety and effectiveness as well,” said Rep. Buddy Carter, R. Ga., who led the fight for the FDA Modernization Act in the House Energy and Commerce Committee. “I also know we can do better when it comes to preclinical testing methods and apply 21st century strategies that rely on human biology, not so much on beagles.”
“Leaders of the House and lawmakers 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 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.”
Our drug development paradigm, framed by the Federal Food, Drug, and Cosmetics Act (FFDCA) of 1938, relies on animal tests for safety and efficacy evaluation. 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, failing in 95 percent of cases when they go to human clinical trials. This antiquated process of pharmaceutical innovation slows delivery of palliatives and cures for patient groups, drives up drug costs, and sacrifices countless animals, including mice, rats, dogs, and non-human primates.
The Center for a Humane Economy, Animal 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, 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 more than 150 organizations and businesses that endorsed the FDA Modernization Act.
Click here to watch the video of Rep. Mace and Marty Irby discussing the FDA Modernization Act, and here to watch the video of Rep. Carter and others discuss the legislation in the House Energy and Commerce Committee.
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Animal Wellness Action is a Washington, D.C.-based 501(c)(4) organization with a mission of helping animals by promoting legal standards forbidding cruelty. We champion causes that alleviate the suffering of companion animals, farm animals, and wildlife. We advocate for policies to stop dogfighting and cockfighting and other forms of malicious cruelty and to confront factory farming and other systemic forms of animal exploitation. To prevent cruelty, we promote enacting good public policies and we work to enforce those policies. To enact good laws, we must elect good lawmakers, and that's why we remind voters which candidates care about our issues and which ones don't. We believe helping animals helps us all.
The Animal Wellness Foundation is a Los Angeles-based private charitable organization with a mission of helping animals by making veterinary care available to everyone with a pet, regardless of economic ability. We organize rescue efforts and medical services for dogs and cats in need and help homeless pets find a loving caregiver. We are advocates for getting veterinarians to the front lines of the animal welfare movement; promoting responsible pet ownership; and vaccinating animals against infectious diseases such as distemper. We also support policies that prevent animal cruelty and that alleviate suffering. We believe helping animals helps us all.
The Center for a Humane Economy is a non-profit organization that focuses on influencing the conduct of corporations to forge a 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.
