U.S. Will No Longer Require Animal Testing for New Drugs

The Food and Drug Administration (FDA) will no longer require all drugs to be tested on animals, thanks to the FDA Modernization Act 2.0. The new law has everyone from Sen. Rand Paul (R–Ky.) to People for the Ethical Treatment of Animals (PETA) cheering.

The FDA Modernization Act 2.0 was passed as part of the omnibus appropriations bill that Congress passed in late December. “The inclusion of this bipartisan effort is a step toward ending the needless suffering and death of animal test subjects – which I’m glad both Republicans and Democrats can agree needs to end,” said Paul, who co-sponsored the bill with Sen. Cory Booker (D–N.J.), in a statement.

In addition to reducing animal suffering, the bill “will accelerate innovation and get safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science,” Paul said.

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.

This doesn’t mean that drug companies will start going straight to testing drug toxicity on humans, but that they may rely on alternative methods to animal testing. Language in the Federal Food, Drug, and Cosmetic Act now states that tests may “include animal tests, or non-animal or human biology-based tests methods, such as cell-based assays, micro physiological systems, or bioprinted or computer models.”

These days, “there are a slew of other methods that drugmakers employ to assess new medications and treatments, such as computer modeling and ‘organs on a chip,’ thumb-sized microchips that can mimic how organs’ function are affected by pharmaceuticals,” notes NPR.

The rule change eliminates “an archaic and debilitating government mandate for animal testing of experimental drugs,” said Wayne Pacelle, president of Animal Wellness Action and the Center for a Humane Economy.

A statement from PETA said the new law “signals a radical shift in the way drugs and treatments are developed.” It’s now pushing for the National Institutes of Health (NIH) “to get with the program” and stop conducting unnecessary experiments on animals. The group’s Research Modernization Deal calls on the NIH to “stop using animals in areas of research where we know this approach isn’t leading to treatments for humans” and “redirect public funding toward sophisticated, non-animal methods,” arguing that “reliance on animal models diverts funds from more promising areas of research and delays the development of effective drugs and treatments.”

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FREE MINDS

From jokes to jail. “Humorless government agents have recently inflicted unlawful retaliation against harmless pranksters, and courts have shielded those agents from accountability,” warn Thomas Berry and Nicholas DeBenedetto in USA Today. The pair summarize recent cases of people arrested and jailed for parodying police or making jokes about them. Charges in one case were dropped; the man in the other case was eventually acquitted. “Both then sued to receive compensation for their ordeals,” note Berry and DeBenedetto:

But in both cases, the police raised the defense of qualified immunity, a judge-made doctrine that insulates government officials from liability for violating constitutional rights.

Plaintiffs can overcome qualified immunity only if they can identify a case with nearly identical facts as a precedent and prove that the constitutional right in question was “clearly established” at the time it was violated. In both cases, courts found that this bar was not met and denied relief.

First Amendment rights are, of course, very well-established, and many First Amendment cases have concerned humor and p