Press Release
On Thursday, the U.S. Senate passed the FDA Modernization Act 2.0, S. 5002 – that was introduced earlier this week – without dissent, taking a major step toward enacting a policy that would dramatically reduce testing on dogs, primates, and other animals in the years ahead. The measure would also help reduce drug costs and time to market by ending an unnecessary and burdensome federal mandate that drives up drug costs and deliverability.
The bill, introduced by Senator Rand Paul, R-Ky., Cory Booker, D-N.J., and 10 other bipartisan Senate cosponsors, would eliminate a 1938 Depression-era federal mandate that requires animal testing for all new drugs approved by the Food and Drug Administration. The legislation’s House companion bill, H.R. 2565, led by Reps. Nancy Mace, R-S.C., Vern Buchanan, R-Fla., and Elaine Luria, D-Virg., and cosponsored by pharmacist Rep. Buddy Carter, R-Ga., was shepherded to passage through the House Committee on Energy and Commerce by Carter and veterinarian Rep. Kurt Schrader, D-Ore., earlier this year. For the FDA Modernization Act to become law, the House will now have to pass S. 5002, that the Senate just cleared. H.R. 2565 currently has 95 bipartisan cosponsors with 40 Republicans and 55 Democrats on board.
The Senate-passed bill also includes language from an additional proposed reform, the Reducing Animal Testing Act, authored by Senator Ben Ray Lujan, D-NM, to amend the Public Health Service Act to remove the animal testing requirement for biosimilars. S. 5002 mirrors provisions of the original FDA Modernization Act provision approved as an amendment to an FDA legislative package taken up in June by the Senate Health, Education, Labor and Pensions (HELP) Committee.
“The FDA Modernization Act is 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,” said Marty Irby, executive director at Animal Wellness Action who was named one of The Hill’s Top Lobbyists for 2019-2021. “We applaud Reps. Buddy Carter and Nancy Mace for their tireless work to help animals and appreciate their leadership on the FDA Modernization Act in the chamber closest to the American people.”
“The FDA Modernization Act will lead to safer, more effective drugs without unnecessary animal suffering,” said Rep. Buddy Carter, R-Ga. “By cutting the FDA red tape, we can create a medical industry that is more humane and better poised to provide life-saving aid.”
“Scientists have known for decades animal testing is far from the best way to test the effectiveness of a new drug,” said Rep. Nancy Mace, R-S.C. “Regardless, the FDA requires anyone developing a new drug to rely on outdated and inhumane animal testing techniques to get their approval. Our bill finally opens the door to new and modern testing techniques to be used at the FDA.”
“The FDA Modernization Act 2.0 will accelerate innovation and get safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science, and I'm proud to have led the charge with our fellow cosponsors. The passage of this bipartisan bill is a step toward ending the needless suffering and death of animal test subjects – which I'm glad both Republicans and Democrats can agree needs to end,” said Dr. Rand Paul, R-Ky.
Animal Wellness Action, the Center for a Humane Economy, and nearly 200 organizations, medical associations, biotech, and patient advocacy groups back the FDA Modernization Act and are calling on the full U.S. House to take up the measure. This groundbreaking legislation has the potential in the coming years to reduce the use of millions of animals and to deliver safer, more effective drugs to patients.
Other cosponsors of the Senate-passed bill include 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., Ben Ray Lujan, D-N.M., and Rick Scott, R-Fla. A previous version of this legislation was also introduced by Sen. Paul with Senators John Kennedy, R-La., Marco Rubio, R-Fla, Mike Lee, R-Utah, and Tim Kaine, D-Virg. cosponsoring that version, S. 2952.
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. This antiquated process of pharmaceutical innovation slows delivery of palliatives and cures for patient groups, drives up drug costs, and sacrifices countless animals.
