Support FDA Modernization Act rider to FDA User Fee Packages

I’m writing to urge you to support the FDA Modernization Act (S. 2952 in the Senate and H.R. 2565 in the House).

The FDA Modernization Act is included as a rider in H.R. 7667, the Food and Drug Amendments of 2022, which passed the House 392 to 28. The Senate HELP committee also recently passed its version of the package (FDASLA – S.4348) and that legislation package also includes the FDA Modernization Act. But now Senator Richard Burr of North Carolina has introduced legislation to strip all riders from the bill, obliterating the FDA Modernization Act in the process.

The FDA Modernization Act is a transformative bill that would eliminate an 84-year-old requirement for animal testing for new drugs and vaccines. It would enable the transition to non-animal test methods to test the safety and efficacy of new drugs such as advanced cell-based assays, organ chips, sophisticated computer modeling, and other human biology-based test methods.

For example, researchers recently assessed the performance of Liver-Chips – miniaturized organs-on-a chip – to evaluate the toxicity of 22 known drugs. The study demonstrated that the Liver-Chip was able to correctly identify 87 percent of the tested drugs that had caused drug-induced liver injury in patients after passing through animal testing.

Notably, the liver damage experience by these patients resulted in 208 fatalities and 10 liver transplants. Had these drugs been tested using the Liver-Chip instead of animals, it appears likely that many of these fatalities and severe liver injuries would have been avoided.

The FDA Modernization Act is a groundbreaking bill that can lower drug costs, speed delivery of drugs, reduce the number of animals used, and increase the safety and effectiveness of drugs and vaccines. It must be preserved.

I urge you to please support the FDA Modernization Act and keep it in any final legislative package that provides funding to the Food and Drug Administration.

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