Congress Should Make FDA Animal Testing Optional, Repeal 1938 Mandate

We have an archaic national policy in the United States that requires animal testing in every case for drug and vaccines, even when superior methods are available. Senate and House leaders united in 2021 to introduce the FDA Modernization Act, H.R. 2565 and S. 2952, for the first time. The measure would reform our drug approval process and to drive the use of non-animal testing methods.

Our drug development paradigm, framed by the Food, Drug, and Cosmetics Act 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 largely 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 treatments and cures for patients, drives up drug costs, and sacrifices countless animals, including mice, rats, dogs, and non-human primates.

The legislation, introduced by Sens. Rand Paul, R-Ky., Cory Booker, D-N.J., Mike Braun, R-Ind., John Kennedy, R-La., and Ben Ray Lujan, D-N.M. and Reps. Vern Buchanan, R-Fla., Elaine Luria, R-Virg., and Nancy Mace, R- S.C., has the potential in the coming years to prevent the use of millions of animals and to deliver safer, more effective drugs to patients. A coalition of 200 businesses, biotech, medical associations, patient advocacy groups, and non-profits have backed the measure to be included as a rider to a final package of the must-pass FDA user fee reauthorization. This inclusion was backed by committee leaders in both the House and the Senate.

The House of Representatives passed its FDA legislative package in a landslide vote of 392 – 28, after the committee passed the measure 55 – 0 and included the Buchanan-Luria-Mace bill thanks to their work as well pharmacist Rep. Buddy Carter, R-Ga., and veterinarian Rep. Kurt Schrader, D-Ore., who ushered the measure through the House Energy and Commerce Committee. The Senate HELP Committee passed its version of the package in June and included the FDA Modernization Act as well. As the September 30th deadline to pass the FDA user fee reauthorization legislation looms, the “4-corners” of the committees from both chambers, have reached a deal on their final version of the legislation. While the agreement provides for a “slimmed down” version of the two packages, it is unknown which riders, if any, will remain.

The final user fee package is expected be attached to the Continuing Resolution (CR) to fund the government through the election and into December, according to some lawmakers involved in the negotiations. The House and Senate are expected to act on the CR by September 30th, when government funding for the current fiscal year expires.

Will Congress miss the opportunity to pass groundbreaking legislation that will revolutionize drug development that will lower drug costs, speed delivery of drugs to patients, and reduce the number of animals used in science? Let’s hope that Senate leaders Patty Murray, D-Wash., Richard Burr, R-N.C., and House leaders Frank Pallone, D-N.J., and Cathy McMorris Rodgers, R-Wash., will grab the opportunity and run with it. 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 caused the average American family’s living costs to skyrocket.

Marty Irby is the executive director at Animal Wellness Action and senior vice-president at the Center for a Humane Economy who was named one of The Hill’s Top Lobbyists for 2019-2021, and resides in Washington, D.C. Follow him on Twitter or Instagram @MartyIrby