FDA initiates review of all research with nonhuman animals

APA voices concerns about precedent and neglect of scientific advice and emphasizes the importance of animal models.

In a statement released on January 26, 2018, Scott Gottlieb, MD, Commissioner of the Food and Drug Administration (FDA) announced that he had initiated an “independent, third-party investigation of the agency’s animal research programs.”  However, he provided no details about who would conduct this investigation or what processes it would follow. 

Gottlieb also announced the establishment of a “new Animal Welfare Council to provide centralized oversight of all animal research activities and facilities under the agency’s purview.”  Similarly, no information was given about the composition of this council, its specific charge and authorities, or how it would interact with scientific bodies within the FDA.

These moves were taken following the Commissioner’s suspension in September 2017 of a research project examining the behavioral and biological effects of various doses of nicotine in adolescent and adult squirrel monkeys.  That suspension was made in response to a letter from primatologist Jane Goodall, sent at the behest of the White Coat Waste Project, an organization that opposes virtually all research with nonhuman animals.

At the time of the suspension, the American Psychological Association (APA), American College on Neuropsychopharmacology, and College on Problems of Drug Dependence raised questions about the process by which the study was reviewed and why a study that had previously been deemed of high scientific and public health merit would be put on hold. 

In his recent statement, Gottlieb said that the study was permanently ended, due to “a generalized lack of adequate oversight” and “deficiencies that occurred under the third-party animal welfare contractor,” which provided veterinary care.  No concerns were expressed about the research team’s treatment of or interactions with the monkeys, which are now to be moved to a sanctuary.

The APA and many addiction researchers are now raising further questions about the FDA’s handling of research with nonhuman animals, including:

  • Why has the FDA not provided details about the reviews of animal research that it has conducted and plans to pursue, including who performs them and according to what criteria?
  • Why did the FDA terminate the monkey nicotine project, rather than take steps to improve or replace inadequate veterinary care, which would have enabled a study of high scientific and public health merit to continue?  
  • Why were FDA’s standing scientific bodies, in particular the Science Advisory Board to the National Center for Toxicology Research, apparently not consulted in the decisions to close the study or to pursue new forms of oversight of animal research?

Research with animals plays a critical role in a wide range of health research (see, for example, The Importance of Nicotine Research with Nonhuman Animals).  At the same time, the welfare of research animals must be a high priority.  The APA is concerned that the closure of the monkey nicotine study may serve as a precedent for further FDA actions that will inhibit animal research that is ethically sound, scientifically meritorious, and in the public interest. 

Looking forward, the APA will seek answers to the questions noted above and calls on the FDA to adopt a transparent and scientifically-informed approach to sponsoring and overseeing animal research.