The FDA will send a team of primate experts to the FDA’s National Center for Toxicological Research in Arkansas, where the research is taking place, to evaluate the safety of the monkeys. In addition, a FDA team consisting of senior officials and primate veterinarians will assess the “science and integrity” of the research process to determine if the study should be terminated, according to the report.
The experiment involved training squirrel monkeys to press a lever to receive nicotine to examine behavioral and biological effects of the drug. Since the study began in 2014, four monkeys have died. It is unclear if the deaths were related to nicotine.
The FDA halted the research after primatologist Jane Goodall, PhD, recently raised concerns over the study. She called the research “cruel and unnecessary” and “shameful” in a letter to Dr. Gottlieb.
The FDA is also considering establishing a “function that would provide for even greater oversight of the care of animals in the agency’s possession,” an FDA spokesperson told the Washington Post.
More articles on supply chain:
Express Scripts CMO: Healthcare system isn’t set up to pay for Novartis’ $475k cancer drug
WHO: The world has a serious lack of new antibiotics under development
Teva to sell remaining women’s health assets in 2 deals totaling $1.38B
