WASHINGTON – Sen. John Kennedy (R-La.) today joined Sen. Cory Booker (D-N.J.) and colleagues in introducing the Food and Drug Administration (FDA) Modernization Act 3.0. The bill would require the FDA to implement the FDA Modernization Act 2.0 (FDAMA 2.0) to update drug testing to meet modern standards.

In 2022, Congress passed the FDAMA 2.0, which Kennedy helped introduce and Pres. Joe Biden signed into law. The law removes a requirement under the Federal Food, Drug and Cosmetic Act for mandatory testing on animals before human clinical trials. 

“The Biden administration had two years to implement the FDA Modernization Act 2.0, but it didn’t act. Congress should send this bill to Pres. Trump’s desk to help protect animals from mandatory testing at the FDA,” said Kennedy.

“It’s been over two years since Congress ended the statutory mandate that investigational new drugs (INDs) undergo mandatory animal testing before human clinical trials. We cannot allow the FDA to continue to delay on implementing this critical law. If passed, this bipartisan legislation will require FDA to finally update its regulations and will pave the way for more scientifically reliable and humane methods of drug development,” said Booker.

Under the FDAMA 2.0, the FDA would be required to use other methods of testing, such as organ chips, computer modeling and bioprinting, before human trials. The FDA Modernization Act 3.0 would mandate the FDA to update its regulations for testing within 12 months of enactment.

Sens. Eric Schmitt (R-Mo.), Rand Paul (R-Ky.), Angus King (I-Maine), Sheldon Whitehouse (D-R.I.), Richard Blumenthal (D-Conn.), Ben Ray Luján (D-N.M.) and Roger Marshall (R-Kan.) also cosponsored the legislation.

The full bill text is available here.