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Congress passes FDA act that would do away with animal testing requirement

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The U.S. House has approved the FDA Modernization Act 2.0, which would end the animal testing requirement for new drugs and biosimilars.

The bill doesn’t completely ban testing on animals but enables drug developers to use alternatives when feasible.

In September, the U.S. Senate passed the FDA Modernization Act 2.0, S.5002.

The new policy, known as the Reducing Animal Testing Act, was attached to the $1.7 trillion omnibus spending bill.

Before Christmas, Biden vowed to sign the bill as soon as it reached his desk.

Section 3209 of the bill amends the Federal Food, Drug, and Cosmetics Act (FFDCA) to specify “nonclinical tests” instead of “preclinical tests.” It also swaps the term “animal” for “nonclinical tests” and adds new text identifying that “nonclinical tests” may incorporate human-relevant test…

Q&A: What the transition away from animal testing could mean for drug discovery

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In September, the U.S. Senate unanimously passed the FDA Modernization Act 2.0, which would lift an 84-year-old federal mandate for animal testing for toxicity studies. While the bill doesn’t ban animal testing outright, it would allow drug developers to use alternatives when feasible.

The Senate has sent the bill, also known as S. 5002, to the House. Senators Rand Paul (R‑KY) and Cory Booker (D‑NJ) co-sponsored the bill. The bill has good odds of passing the House before the end of the year, according to a WSJ op-ed.

To learn more about alternatives to animal testing in drug development, we reached out to Susan Murphy, the president of Molecular Devices, which works to enable high-throughput organoid research for life scientists.

What does the transition away from animal testing mean to you?

Susan Murphy

Murphy: …

FDA Modernization Act to end animal testing requirement passes U.S. Senate

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Today, the U.S. Senate passed the FDA Modernization Act 2.0, S.5002, without dissent.

Introduced by Senators Dr. Rand Paul (R-KY) and Cory Booker (D-NJ), the bill, if enacted, would curb animal testing in the coming years. A total of 10 other cosponsors backed the bill, which would end the mandate to test new drugs and biosimilars on animals.

The bill was based on S.2952, the FDA Modernization Act of 2021.

“This is the biggest policy development in Congressional history on the fight to replace animal testing with morally and scientifically superior methods,” said Dr. Paul in a statement. “The FDA Modernization Act 2.0 will accelerate innovation and get safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science, and I’m proud to have led the charge with our fellow cosponsors.”

“Thanks to modern scientific innovat…

Drug discovery evolves: Jump-starting the transition from animal models to human preclinical models

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Animal models, long the basis of academic research and preclinical drug discovery, continue to play an important role in advancing our understanding of basic pharmacology and bringing critical therapies to those in need. However, animal models have some natural drawbacks (e.g., not being humans) that hamper their ability to fully predict the interaction of new chemical entities with human physiology. Nonetheless, animal models remain the lynchpin of preclinical research the world over. Given the long-standing paucity of suitable human-based models to replace them, this should come as no surprise. Indeed, while both primary and immortalized human cells have long been available for in vitro research using standard tissue culture techniques, the primarily 2D nature of such in vitro studies is not sufficient to replicate human tissue’s complex structure and function.

These fundamenta…

When can computer models replace animal trials?

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The pandemic has forced a rethink of clinical research, but the pharma industry continues to rely on animal testing. While pundits have observed that computer modeling and techniques such as microdosing can reduce animal testing, animal testing continues to be integral in preclinical studies.

But computer models are now sufficiently accurate to predict the response of many drugs, said David Harel, CEO of CytoReason (Tel Aviv, Israel). “We are getting to the point that computer models of certain diseases can generate better predictions than animal models,” he said.

But there are caveats. It could take longer to move from animal-based safety testing, which often involve rodents. Such animal trials tend to be limited in size. “They’re not a big burden. And they’re not super expensive,” Harel said. And regulators frequently consider animal data when evaluating drug safety. But …