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FDA Modernization Act Update
The FDA Modernization Act, which would add non-animal methods to the list of acceptable nonclinical test methods in drug development, was introduced last year by Reps. Vern Buchanan, R-Fla., Elaine Luria, D-Va., has been cosponsored by 46 House Democrats and 38 House Republicans. A Senate companion bill, S. 2952, was introduced by Senators Rand Paul, R-Ky., Cory Booker, D-N.J., and also attracted a broad set of Democrat and Republican cosponsors.
On May 18th, the House Energy and Commerce Committee passed the FDA Modernization Act as a rider to a larger package of the FDA user fee reforms, strengthening the chance of enactment this summer for a measure that would eliminate a statutory animal testing mandate for new drug development. The legislation doesn’t eliminate animal testing but allows for the use of modern non-animal methods. Last week, the Senate HELP Committee introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022, which includes a similar rider containing language from the FDA Modernization Act.
The Center for a Humane Economy, Animal Wellness Action, the Animal Wellness Foundation, the Michelson Center for Public Policy, National Medical Association, Emulate Inc., PETA, Citizens for Alternatives to Animal Research and Experimentation, and dozens of other organizations and corporations in a “Modernize Testing” coalition applauded the action. The FDA Modernization Act is included as Section 701 in a legislative package known as the Food and Drug Amendments of 2022, H.R. 7667. H.R. 7667 passed 55 – 0.
The full legislative package is set for final action for a full vote in the House and markup in the Senate in June and may pave the way for the phase-in of non-animal test methods in new drug development and a reduction in the use of animals. The two chambers hope to complete all work on the new policies by summer’s end.
The FDA Modernization Act does not seek to settle the debate over animal testing, but to apply the widely accepted view that where alternative methods exist, they should be used. That notion is enshrined in the broadly accept construct of the “3Rs” approach – Reduction, Refinement, and Replacement — to animal testing.
In recent decades, almost all major research organizations, pharmaceutical companies, academic institutions, and even government agencies have embraced the principle. The FDA Modernization Act allows the government and pharmaceutical companies to act on their pledges.
We cannot have progress for people and animals in the realm of drug development until the Federal Food, Drug and Cosmetics Act of 1938 is changed. The provisions of the FDA Modernization Act offer the prospect of ushering in a cultural change at the FDA and in the pharmaceutical industry so that 21st-century science is developed and put into practical use. Follow through with regulation and guidance changes will follow legislative action.
To join the Modernize Testing Coalition to support this legislative effort, please sign up here.
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9 Replies
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Cool! Love it Tamara!
Thanks for sharing! ?
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You’re welcome!
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Hi Tamara,
Thank you for sharing a view that’s different from the science, but equally important.
I learned a lot from your post, particularly how to engage and take action.
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For anyone tracking progress on the FDA Modernization Act, we are one step closer now that it has officially passed the house.
“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 would accelerate innovation and get safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science,” said U.S. Senator Rand Paul.
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Next stop will be the Senate floor. The House and Senate versions will have to be reconciled. They are shooting for August 1st, but the bill must pass before the September 30th deadline.
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Hi Tamara,
Thanks for your Senate HELP Committee press release.
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Of course. I will keep everyone updated!
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@Tamara – Any chance you’ve heard any updates on how likely it is that the bill will be reconciled by the August 1st target? And any insight on what would happen to the bill if it was delayed past the Sept. 30th deadline?
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The “hope” is to get it reconciled and voted on in both houses before the August 1st recess, but it’s not guaranteed. The “four corners” are working on reconciliation now (four corners = Chairs and Ranking Members of House Health Subcommittee, Palone and McMorris Rogers, and Chair and Ranking of the Senate HELP Committee, Murray and Burr). The versions are quite different, but I know that they want reconciliation completed before going forward. If the bill were delayed past the September 30th deadline, there would likely be a continuing resolution to continue FDA funding. This is not the scenario we want and I know that legislators (at least most) want this completed. Sorry I can’t give a concrete answer, we just have to wait and hope they can work this out before August.