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U.S. House Should Take Up FDA Modernization Act for a Vote

Legislation repeals a 1938 federal mandate requiring animal testing for any drug approved by FDA that drives up drug costs, time to market

Wayne Pacelle, Marty Irby (in background), Senator Rand Paul, and pup at a 2021 press conference on the introduction of the FDA Modernization Act
Wayne Pacelle, Marty Irby (in background), Senator Rand Paul, and pup at a 2021 press conference on the introduction of the FDA Modernization Act (Photo: Office of Senator Rand Paul, R-Ky. )

When the FDA Modernization Act was first introduced in 2021 we saw a bill that made common sense and that had appeal to both sides of the aisle. Its broad bipartisan support is unparalleled in the animal protection space. This measure will reset our drug development paradigm in the U.S. for the better, helping millions of animals and patients in need of treatments and cures.

Now that the measure has passed the Senate by Unanimous Consent, it’s ripe for final action. It can pass either by coming up as a stand-alone measure on the House floor or as an amendment to the year-end spending package, delivering a great outcome for patients’ rights, scientific integrity, and animal welfare.

Three Democrats and two Republicans introduced the House bill, H.R. 2565: Reps. Vern Buchanan, R-Fla., Nancy Mace, R-S.C., Elaine Luria, D-Va., Mikie Sherrill, D-N.J., and Brendan Boyle, D-Pa. Sens. Rand Paul, R-Ky., Cory Booker, D-N.J., Mike Braun, R-Ind., Ben Ray Lujan, D-N.M., and John Kennedy, R-La., teamed up in introducing a companion bill in the Upper Chamber. In both cases, it was an unlikely group of allies working together to achieve results even as the political parties sniped at each other on a range of other subjects.

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The FDA Modernization Act would very simply repeal a 1938 Depression-era mandate that requires animal testing for any drug or vaccine approved by the FDA. There’s a tremendous unnecessary burden on drug companies to complete animal testing despite a 95% failure rate when it comes to the effects of drugs on animals versus humans. To make matters worse, this unnecessary testing drives up drug costs and time to market, a terrible tax on the American people during this challenging economic climate with record-breaking inflation heading into to what many economists deem a probable recession in 2023.

The legislation, backed by more than 200 organizations, drug companies, biotech companies, animal protection groups, and even some pharmaceutical companies, has 111 bipartisan House cosponsors with a range of ideological beliefs -- from House Appropriations Chair Rosa DeLauro, D-Conn., to House Republican Conference Chair Elise Stefanik, R-N.Y. to veterinarian Kurt Schrader, D-Ore., and pharmacist Buddy Carter, R-Ga.

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The FDA Modernization Act advanced through the full process of regular order in the House Energy and Commerce Committee and cleared the full House in a larger FDA-related package in the summer. The Senate HELP Committee included it in its companion package but that larger measure stalled before it reached the floor. As an alternative strategy, Sens. Paul and Booker then reintroduced the bill as approved by Senate HELP. That bill, S. 5002, the FDA Modernization Act 2.0, is what passed by Unanimous Consent on September 29th.

While the House has passed a few key animal protection measures in the second half of 2022, including the Big Cat Public Safety Act, H.R. 262, the output of animal protection is short of what's needed to stop needless and dangerous mistreatment of animals in our society. The Congress can also close out work on the Shark Fin Sales Elimination Act this week with the Senate taking up the National Defense Authorization Act (NDAA).

Enacting the FDA Modernization Act would be a tremendous gesture of good will for animals and advocates alike as the Biden Administration has performed very poorly on animal welfare. The Administration is rounding up our iconic American wild horses and burros and incarcerating them in record-breaking numbers so ranchers can put more cattle on federal lands. The Administration abruptly shut the door on dog imports from 113 countries last year with no notice – leaving the pets of American heroes in the military, diplomats, and many traveling on vacation stranded in foreign countries. And it’s even suggesting that trophies of threatened African elephants come into the country, after U.S.-based trophy hunters shoot them for their ivory tusks.

S. 5002 that garnered a wide array of cosponsors from Sen. Bernie Sanders, D-VT, to Dr. Roger Marshall, R-Kans., now awaits action and is being held at the House desk. If it’s afforded a vote in the Chamber closest to the American people, it will easily pass with more than 400 YES votes and can be swiftly sent to the White House for President Biden to ink the measure into law, giving voters, the Congress, and the President a major win for animals.

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

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