Drugs

FDA to Phase Out Some Drug Animal Testing

David McFarland

— 1 min read
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FDA says it is phasing out the animal testing requirement for monoclonal antibodies and some other drugs. A 4/10 statement says animal testing would be replaced with “more effective, human-relevant methods. The new approach is designed to improve drug safety and accelerate the evaluation process, while reducing animal experimentation, lowering research and development costs, and, ultimately, drug prices.”

Possible replacement approaches, the statement says, include artificial intelligence (AI)-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (known as New Approach Methodologies or NAMs). FDA says implementation of the new approach will begin immediately for IND applications where NAMs data are encouraged. To determine efficacy, the statement says, the agency will also begin using preexisting, real-world safety data from other countries, with comparable regulatory standards, where the drug has already been studied in humans.

“For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally,” said FDA commissioner Martin Makary. “This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use. By leveraging AI-based computational modeling, human organ model-based lab testing, and real-world human data, we can get safer treatments to patients faster and more reliably, while also reducing research and development costs and drug prices. It is a win-win for public health and ethics.”

The statement lists these “key benefits of replacing animal testing in monoclonal antibody safety evaluation”:

 

  • advanced computer simulations to predict a drug’s behavior;
  • human-based lab models to reveal toxic effects that can be undetected in animals;
  • regulatory incentives such as potentially streamlined review for companies submitting data from new methods;
  • faster drug development; and
  • global leadership in regulatory science.

For patients, Makary said, the proposal “means a more efficient pipeline for novel treatments. It also means an added margin of safety, since human-based test systems may better predict real-world outcomes. For animal welfare, it represents a major step toward ending the use of laboratory animals in drug testing. Thousands of animals, including dogs and primates, could eventually be spared each year as these new methods take root.”

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