Rand Paul: Why Is the FDA Still Requiring Human or Animal Testing For New Drugs?

"The FDA's regulations related to animal testing no longer fully conform with applicable law," writes the Kentucky senator.

Congress unanimously passed the FDA Modernization Act 2.0 in December 2022. The law allows drug companies to find alternative methods of assessing their products, without testing them on animals or human beings.

The bill was sponsored by Sens. Rand Paul (R–Ky.) and Cory Booker (D–NJ)*. Its goal was to speed up the drug approval process, and to let scientists experiment with approaches methods that are more humane than testing on live subjects. Reason's Elizabeth Nolan Brown aptly summarized the bill's achievements, noting that "previously, all drugs in development were required to undergo animal studies before being tested in human trials. Now, drug companies will still have the option to start testing experimental drugs on animals, but they won't have to."

And yet the Food and Drug Administration (FDA) has not taken action to update the agency's regulations.

"The FDA's regulations related to animal testing no longer fully conform with applicable law," writes Paul in a letter to FDA Commissioner Robert Califf.

Paul's letter, obtained exclusively by Reason, was co-signed by Booker and several other senators from both parties. It notes that the FDA has previously spoken positively about moving away from animal testing. But companies currently submitting applications for drug approval still have to deal with FDA requirements that stipulate human or animal testing—at least on paper.

"These and other regulatory provisions no longer reflect the full scope of the governing statute and should therefore be updated as expeditiously as possible," writes Paul.

The FDA should swiftly update its written requirements for new drugs. Until it does, this is a powerful reminder that even when the Congress, the president, and the agency itself all agree that a regulation should be undone, deregulatory efforts can hit a dead end.

There is no reason to force scientists to experiment on living creatures if better testing methods are available. What's the holdup, bureaucrats?