Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 06 October 2017 | By Zachary Brennan
FDA last month halted monkey research on nicotine dosing following concerns, including those raised in a letter from primatologist Jane Goodall.
Although an FDA spokesperson told Focus that the decision to halt the study last month was made independently from Goodall’s letter to FDA Commissioner Scott Gottlieb, according to the letter, FDA was performing research at its National Center for Toxicological Research (NCTR) in Jefferson, Arkansas involving more than a dozen squirrel monkeys, with nicotine delivered directly into their bloodstreams via implants to test the relationship between nicotine dosing and addiction.
According to an NCTR annual report from 2016, a nonhuman-primate behavioral pharmacology laboratory had been created to support the needs of FDA’s Center for Tobacco Products, with initial studies to assess the ability of tobacco-product constituents to actually produce and maintain addictive behaviors.
"Studies are underway to develop physiologically-based pharmacokinetic models to help define and quantitate exposures. Concomitant PET-imaging studies are being conducted to explore aspects of neurochemical changes associated with exposure to nicotine and other tobacco-product constituents," the report said.
Gottlieb said in a response letter dated 25 September that, "At this time, all experimentation involving the monkeys in the study you referenced has been halted."
He said he also asked a medical team of primate experts to conduct a follow-up visit to evaluate the safety and well-being of the monkeys. In addition, he said he appointed an independent FDA review team to assess the science and integrity of the animal research process for this study.
And although Gottlieb said there has been an evolution of in vitro assays and computer models "that can, in certain circumstances, replicate and replace the need for animal-based and human studies, while still providing access to critical, reliable data … currently there are still some areas for which non-animal testing is not yet a scientifically valid and available option."
The comments follow a preliminary opinion released earlier this year from the European Commission and its Scientific Committee on Health, Environmental and Emerging Risks reiterating that, when alternatives do not exist, the appropriate use of non-human primates remains essential to some biomedical and biological research, as well as for pharmaceutical safety assessments.
Tags: nicotine research, NCTR, FDA research
Regulatory Focus newsletters
All the biggest regulatory news and happenings.