House Advances FDA Modernization Act to End Animal Testing Mandates

With the start of the 117th Congress in January 2021, we set a national agenda for animal protection and began working to see the introduction of a raft of new measures that would better protect the animals we all care so deeply about.

Of course we wanted to see movement on bills that have been around for a decade or longer – the Prevent All Soring Tactics (PAST) Act to end the painful scourge of intentionally inflicting pain to Tennessee Walking Horses’ feet to induce an artificial pain-based gait known as the “Big Lick;” the Humane Cosmetics Act to eliminate the already dying practice of cosmetics companies relying on animals for safety testing; and the SAFE Act to ban the slaughter of American horses at home or abroad. But those bills just haven’t moved after years of work, and so we’re working to execute new strategies in these areas, and are finally seeing some progress.

On horse slaughter, we conceived and worked to pass an amendment in the House to ban the transport of horses for slaughter in Canada and Mexico. Sadly, the Senate did not pick up the pro-horse provision, and it looks bleak that the Congress will act on this long overdue measure.

In 2022 we passed a House amendment to the America COMPETES Act to ban mink farming in the U.S., as mink are the number-one superspreader of COVID besides humans, with the ability to mutate the disease and create new variants and spread them to people across the globe. We’ve also introduced measures to stop the trade of kangaroo parts to the United States, mainly used for athletic shoes, and to create an Animal Cruelty Crimes section at the Department of Justice.

While we’re uncertain where these new measures will end up as the Congress approaches its final months in session before the August recess, we are very encouraged that one measure stands a good chance of enactment: the FDA Modernization Act, H.R. 2565/S. 2952, led by Reps. Vern Buchanan, R-Fla., Nancy Mace, R-S.C., and Elaine Luria, D-Va., in the House, and Sens. Rand Paul, R-Ky., Cory Booker, D-N.J., and Mike Braun, R-Ind., in the Senate.

The measure, conceived in collaboration by Animal Wellness Action, the Animal Wellness Foundation, the Center for a Humane Economy, and the Michelson Center for Public Policy, would very simply repeal a 1938 mandate in the Federal Food Drug and Cosmetics Act (FFDCA) that requires animal testing for any drug approved by the FDA. This legislation allows for the use of human-biology-based test methods, providing for use of the best science available. More than 90 percent of drugs found safe in nonclinical tests fail during human clinical trials, largely due to toxicities not predicted by animal tests or simply because they just don’t work on humans.

The FDA Modernization Act is backed by a long list of Biotech companies, PHARMA, animal protection groups, and medical doctors, as well as dozens of cosponsors split almost evenly between Democrats and Republicans. That bipartisan approach is a key aspect of the progress of this legislation in a Congress also almost evenly divided between the parties.

Thanks to the efforts of Committee Members such as pharmacist Buddy Carter, R-Ga.; veterinarian Kurt Schrader, D-Ore.; subcommittee Ranking Member Brett Guthrie, R-Ky.; and the bill sponsors; the FDA Modernization Act was added as a rider to the House legislation that would reauthorize FDA user fees. The legislation is a “must pass” that funds 45 percent of the Agency, and must be signed into law by August in order to prevent FDA from furloughing a thousand employees or more, increasing the chance of final action on the measure.

The FDA Modernization Act is much more than just an animal protection bill. It’s a measure that will almost certainly reduce the cost and time to market for many, many drugs in the future, ultimately saving lives, and saving taxpayer dollars. There are far better methods to test new drugs in 2022.

According to my colleagues at the Center for a Humane Economy, Tami Drake and Wayne Pacelle: “Human-relevant cell-based assays, organs-on-a-chip, human-on-a-chip (micro physiological systems), and computer modeling have been developed to more accurately predict human response to new drugs, yet the FFDCA does not officially acknowledge these superior test methods. The FFDCA and FDA regulations specifically require the use of animals, to the exclusion of human biology-based nonclinical methods.”

Breakthrough discoveries like these can’t help if they don’t leave the lab.

As we round out the first quarter of the century, it’s time to modernize testing, and ensure the safest methods are used for both animals and humans alike. Contact your members of Congress today by clicking here and asking them to cosponsor the FDA Modernization Act.

Marty Irby is the executive director at Animal Wellness Action in Washington, D.C., and one of The Hill’s Top Lobbyists for 2019, 2020, and 2021, who was honored by Her Majesty Queen Elizabeth II for his work to protect animals. Follow him on Instagram @MartyIrby.