Crapo and Paul Shepherd Bipartisan FDA Modernization Act through Senate to Cut Drug Costs, End Animal Testing Mandates

Sens. Mike Crapo and Rand Paul

Sens. Mike Crapo and Rand Paul

Groundbreaking Legislation has the Potential to Spare Animals, Bring Safer and Better Treatments to Patients, and Drive Down Drug Prices

We applaud Senators Crapo and Paul for their tireless work in the U.S. Senate and appreciate them shepherding this groundbreaking legislation to passage.”
— Marty Irby, executive director at Animal Wellness Action
WASHINGTON, D.C., UNITED STATES, September 30, 2022 / -- On Thursday, the U.S. Senate passed the FDA Modernization Act, 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., and backed by Senator Mike Crapo, R-Idaho, as well as 10 other bipartisan 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. Vern Buchanan, R-Fla., and Nancy Mace, R-S.C., and Elaine Luria, D-Virg., is also backed by 95 bipartisan cosponsors in the House.

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.

“Leaders of the Senate 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 at 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.”

“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 Senators Crapo and Paul for their tireless work in the U.S. Senate and appreciate them shepherding this groundbreaking legislation to passage."

“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 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.

Senator Crapo also has a long history on animal protection issues leading the Animal Wellness Action-backed Prevent All Soring Tactics (PAST) Act, S. 2295, that would end the painful practice of ‘soring’ Tennessee Walking, Racking, and Spotted Saddle Horses as well.

Marty Irby
Animal Wellness Action
+1 202-821-5686
email us here

WEHT FDA Modernization Act Coverage