Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s strengthened commitments to humane and judicious animal research and the termination of a nicotine study

FDA strengthens commitments to humane and judicious animal research and the termination of a nicotine study.

The FDA has a deep commitment to ensuring the responsible and humane care of animals when research involving animals is needed to fulfill the agency’s public health mission. The FDA also is fully committed to complying with the rules and guidance governing animal research. That’s why we acted quickly on concerns related to a study that was working with squirrel monkeys to investigate the role of exposure to various levels of nicotine on the onset of addiction in adolescence and young adults, and why we are announcing today that we are permanently ending this study and placing the animals in a permanent sanctuary home.

Upon learning about the concerns, most troubling the deaths of four monkeys, I immediately placed the study on hold and asked the FDA’s Principal Deputy Commissioner to form an agency review team to determine the safety and well-being of the animals involved in the study, assess the circumstances surrounding the animal deaths, and gather information regarding the conduct of the study to inform decision making as to whether a further independent investigation was appropriate. A team of experienced primate veterinarians and animal-care professionals were quickly organized to conduct a site visit at the FDA’s National Center for Toxicological Research (NCTR) to make sure that the animals involved in the study were being properly cared for in appropriate facilities. I also placed a hold on the initiation of any new animal research at NCTR until the outcome of our review. In addition to conducting two visits to the study site, the team reviewed extensive documentation of procedures and processes related to the study.

While the study animals are safe and being well cared for, the team’s initial review of the NCTR study raised several concerns, including a generalized lack of adequate oversight that could lead to similar issues for other protocols and procedures, as well as several repeated reported deficiencies that occurred under the third-party animal welfare contractor used during the study. Information relevant to their review can be viewed here.

Based on this team’s findings, it is clear the study was not consistent with the agency’s high animal welfare standards and why the agency has permanently ended this study and will place the monkeys involved in a new permanent sanctuary home, which will provide them with appropriate long-term care. However, our work is not done. These findings indicate that FDA’s animal program may need to be strengthened in some important areas. As such, I am taking additional steps to ensure that any concerns related to current processes and procedures have been addressed and to identify additional actions the agency might take to better ensure the welfare of the animals in our care.

First, I have directed an independent, third-party investigation of the agency’s animal research programs, starting with those conducted at NCTR. This investigation, which has been initiated, will ensure not only that we have identified all significant concerns, but also help us identify ways to address any remaining or future issues for the entire animal program.

Second, we have established a new Animal Welfare Council to provide centralized oversight of all animal research activities and facilities under the agency’s purview. This Council will advise the agency on its approach to animal welfare issues and ensure alignment of animal studies with the agency’s mission. The work of the Council is a very high priority for me. Reporting into the FDA’s Office of the Chief Scientist and coordinating closely with experts from each of the agency’s components that engage in lab activities involving animals, I intend to follow the Council’s work closely and provide my full support to their efforts.

Additionally, we are working to reaffirm and strengthen our commitment to replacing, reducing, and/or refining animal studies, often referred to as the “3Rs.” As part of this commitment, the FDA had previously formed the Modeling and Simulation Working Group to accelerate the adoption of modeling and simulation tools in product development and evaluation; and initiated the Toxicology Working Group, which has developed a roadmap for integrating emerging predictive toxicology methods and new technologies into regulatory safety and risk assessments. The FDA also participates in and chairs the Interagency Coordinating Committee on the Validation of Alternative Methods. We already are seeing progress from these recent efforts, including testing methods to ensure live-attenuated oral poliovirus will not result in vaccine-derived cases of polio, the potential for genetic tests to predict drug-induced liver injury in humans, and the possibility of tests to more quickly and efficiently assess whether chemical compounds have the potential to disrupt processes in the human body that may lead to negative health effects.

Although the agency is optimistic that cultivating these types of new technologies can continue to reduce the need for animal testing, it is important to recognize that there are still many areas where animal research is important and necessary. Without animal research, it would be impossible to gain some of the important knowledge needed to prevent human and animal suffering for many life-threatening diseases. In the past, animal research has played a critical role in vital health advancements such as preventing polio, eradicating smallpox and identifying new cancer treatments. Further, there are still some areas for which non-animal testing is not yet a scientifically valid or available option. For example, animal research with primates continues to be an essential part of the safe and effective development of certain critical childhood vaccines.

We understand and share concerns that animals be involved in research only when there is no other way to fulfil an important public health objective. And, when these studies are necessary, the animals involved in research must be cared for under strict, humane guidelines. I am committed to ensuring an effective, humane and judicious animal research program at FDA and I will continue to communicate with our stakeholders on our efforts.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.