The House Energy and Commerce Committee passed the FDA Modernization Act as a rider to a larger package of FDA-related reforms, strengthening the chance of enactment this summer for a measure that would eliminate a statutory animal testing mandate for new drug development. The Senate HELP Committee is considering a similar rider on parallel legislation. In 2021, Democrats and Republicans came together to introduce the FDA Modernization Act, H.R. 2565 and S. 2952, to reform our drug approval process.
The Center for a Humane Economy, Animal Wellness Action, the Animal Wellness Foundation, the Michelson Center for Public Policy, National Medical Association, Emulate Inc., PETA, and dozens of other organizations and corporations in a “Modernize Testing” coalition applauded the action. The FDA Modernization Act is included as Section 701 in a legislative package known as the Food and Drug Amendments, H.R. 7667, which includes key provisions to reauthorize FDA user fee agreements. H.R. 7667 passed today 55 – 0.
“Leaders of the Energy and Commerce Committee, and other 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 Animal Wellness Action.
AWA singled out Committee members Buddy Carter, R-Ga., Kurt Schrader, D-Ore., and Tony Cardenas, D.-Calif., for helping lead the effort in committee, in close cooperation with Ranking Members McMorris Rodgers, R-Wash., and Brett Guthrie, R-Ky., and Chairman Frank Pallone, D-N.J., and Chairman Anna Eshoo, D-Calif. Rep. Mike Doyle, D-Pa., also spoke up in favor of the bill.
The existing drug development paradigm, established by statute in 1938 under the Federal Food, Drug, and Cosmetics Act (FFDCA), relies on animal tests to determine if they are safe and effective for humans. It has a 95 percent failure rate in human clinical trials. Data show that it typically takes 10 to 15 years and an investment of an average of $1 billion and up to $6 billion for a new drug. 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.
“We applaud the Energy and Commerce Committee for taking action to move drug development into the 21st Century and include this important statute change to allow for innovation which will speed drug development, and bring much needed cures to Americans, said Gary K. Michelson, M.D., Founder and Co-chair, Michelson Center for Public Policy. “The most predictive technologies in existence should be available to drug sponsors to provide the safest and most effective medicines for patients.”
“We can apply human biology-based test methods to better predict how humans will respond to drugs in clinical trials,” said Tami Drake, director of research and regulatory policy at the Center for a Humane Economy. “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.”
“Drug testing requirements have not kept pace with scientific innovation, and both the public and animals have suffered for it,” said PETA Senior Vice President of Laboratory Investigations Kathy Guillermo. “The forward-thinking Energy and Commerce Committee recognizes that modern human-relevant test methods are the way of the future and must be embraced.”
Energy and Commerce Committee leaders slightly modified but kept intact the core provisions of H.R. 2565, the FDA Modernization Act, introduced last year by Reps. Vern Buchanan, R-Fla., Elaine Luria, D-Va., Nancy Mace, R-S.C., Mikie Sherrill, D-N.J., and Brendan Boyle, D-Pa. H.R. 2565 has been cosponsored by 43 House Democrats and 37 House Republicans. A Senate companion bill, S. 2952, was introduced by Senators Rand Paul, R-Ky., Cory Booker, D-N.J., Ben Ray Lujan, D-N.M., Mike Braun, R-Ind., and John Kennedy, R-La., and also attracted a broad set of Democrat and Republican cosponsors.
The legislation has been endorsed by more than 140 organizations and companies, including 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.