The rider will lift animal-testing mandate under federal law and drive use of alternatives
WASHINGTON, D.C. – Today, the Center for a Humane Economy, Animal Wellness Action, the Michelson Center for Public Policy, PETA, and dozens of other organizations in a “Modernize Testing” coalition applauded the U.S. House Committee on Energy and Commerce for including the FDA Modernization Act as a rider to a broader legislative package to reauthorize the Food and Drug Administration (FDA) user fee agreements. The FDA Modernization Act, H.R. 2565/S.2952 eliminates a federal mandate for animal testing in new drug development protocols and enables the use of nonanimal test methods in new drug development.
The legislation was introduced in the House 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.. As of May 4th, H.R. 2565 has been cosponsored by 42 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.
“FDA operates under an archaic statute when it comes to drug development, requiring animal-testing strategies even when there are superior non-animal test methods grounded on human biology,” said Wayne Pacelle, president of Animal Wellness Action. “This important domain of science and drug development should not be bound any longer by Depression-era standards and strategies. We applaud the leadership of Energy and Commerce for recognizing the need for reform.” Full committee Chairman Frank Pallone, Jr. (D-N.J.) and Ranking Member Cathy McMorris Rodgers (R-Wash.), along with Health Subcommittee Chairwoman Anna G. Eshoo (D-Calif.), Health Subcommittee Ranking Member Brett Guthrie (R-Ky.), were responsible for including the measure in the broader legislative package. Committee members Kurt Schrader, D-Oregon, and Buddy Carter, R-Ga., were instrumental in driving the outcome.
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 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, slowing delivery of palliatives and cures for patient groups, driving up drug costs, and sacrificing 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 the 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,” says 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.”
The passage of this legislation will provide drug sponsors more options for testing the safety and efficacy of drugs to improve clinical trial attrition rates, cut time to market in half, and substantially reduce R & D costs which could cut drug prices fivefold.
The legislation has been endorsed by more than 125 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.
Chairwoman Eshoo and Ranking Member Guthrie will introduce the “Food and Drug Amendments of 2022” this week, which the Health Subcommittee intends to mark up next week.