The Humane Society of the United States and Humane Society Legislative Fund petition FDA to revise outdated drug testing regulations

WASHINGTON (May 15, 2024)—Today, the Humane Society of the United States and Humane Society Legislative Fund filed a petition with the Food and Drug Administration requesting that the agency updates regulations to make clear that animal testing is not legally required for drug approval. The petition also requests that the FDA create a guidance document encouraging companies to use approved non-animal methods.

“Animal testing is outdated, expensive, cruel and unreliable for gauging whether drugs are safe and effective,” said Kathleen Conlee, vice president of animal research issues at the Humane Society of the United States. “Our petition seeks to end the status quo and accelerate the use of innovative non-animal testing.”

The FDA has publicly expressed support for non-animal methods; however, the agency’s current regulations and guidance documents cause confusion for drug developers on whether animal testing is actually required. The current ambiguity around drug testing requirements discourages innovation at the expense of animals and humans who are waiting for drugs to be developed.

The petition submitted outlines specific actions that the FDA should take to rectify this situation:

  • Amend its regulations to make it clear that the FDA does not require animal testing for drugs.
  • Publish a new guidance document describing the non-animal test methods that can be used in place of animal tests. The document should be updated regularly as new non-animal methods become available.
  • Commit to adding text to all existing and future guidance documents regarding the regulation of drugs. The new text should encourage companies to use non-animal methods whenever possible.

These proposed changes aim to eliminate the uncertainty surrounding animal testing requirements, encourage innovation and promote the use of humane and scientifically reliable testing methods based on human biology.

“Reliance on data from non-animal models will not only protect animals but will also help to make sure drugs are safe and effective for people,” said Tracie Letterman, vice president of federal affairs at Humane Society Legislative Fund. “The FDA should grant the petition and amend its drug regulations to make it clear that animal testing is not required, preventing countless animals from needless suffering.”

Drug development research often involves force feeding, inhaling or injecting animals with large quantities of potentially toxic substances. Countless dogs, cats, rodents and primates are bred, used for drug testing and killed in U.S. laboratories every year.

To an ever-increasing degree, non-animal approaches like organ-on-a-chip technologies, 3D bioprinting, artificial intelligence and machine learning are proving to be superior to animal tests.

The FDA is legally required to consider and respond to the petition. If the agency implements the requests included in the petition, pharmaceutical companies could confidently rely on non-animal test methods in their new drug submissions to the FDA, saving lives and reducing suffering while supplying the market with drugs developed with more human-relevant science.

Read more in our blog.

Media Contact:
Emily Snow Ehrhorn, 202-779-1814,