FDA Commissioner Gottlieb Strengthens Commitment to Animal Welfare and Modern Science

Elizabeth Baker, Esq., senior science policy specialist for the Physicians Committee, issues the following statement in response to FDA Commissioner Scott Gottlieb’s decision to halt the use of monkeys in a nicotine experiment.

When Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., learned that four monkeys died in an experiment on nicotine and addiction at FDA’s National Center for Toxicological Research (NCTR), he placed further animal research on hold and requested a review to assess the well-being of the remaining animals, the circumstances of the deaths, and whether the study should continue. Ultimately, FDA ended the nicotine study and retired the surviving monkeys to sanctuary, which is, to our knowledge, a first for the agency.

The resulting review described animal welfare deficiencies and a lack of oversight, which led Commissioner Gottlieb to call for further examination of the agency’s animal research programs. Commissioner Gottlieb also established an Animal Welfare Council to provide oversight of all animal research activities and facilities under the agency’s purview, and has reaffirmed FDA’s commitment to replacing, reducing, and refining animal experiments.

It is well known that animal tests often do not predict human outcomes and that they are costly, time-consuming, and ethically problematic. Commissioner Gottlieb deserves kudos for acknowledging these concerns and moving forward to address them. We invite Commissioner Gottlieb to make the Animal Welfare Council meetings and proceedings public, so stakeholders and the general public may contribute and follow progress. We also urge Commissioner Gottlieb to ensure that experts in nonanimal methods participate on the council.

Commissioner Gottlieb’s commendable actions here are not standalone.

Under Commissioner Gottlieb’s leadership, FDA recently launched a Predictive Toxicology Roadmap, which will improve the ability of preclinical tests to predict human outcomes. The roadmap highlights multiple human-biology based approaches to assessing the toxicity of new drugs, such as tissue chips and computational models, and provides a framework for evaluating and integrating modern technologies to answer FDA’s regulatory questions. 

Further, as an Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) member agency, FDA has participated in the development of another roadmap.  This roadmap establishes new approaches to assessing the safety of chemicals and medical products in the United States and explores opportunities to improve the human-relevance of product testing.

Commissioner Gottlieb’s willingness to evaluate and end FDA practices that can no longer be justified reflects true leadership—leadership that an agency of such importance deeply needs in order to responsibly fulfill its mission.