Monkey deaths prompt FDA probe, new controls on animal research
In the wake of the deaths, the Food and Drug Administration said Friday that it is reviewing its rules on animal studies and has created a new council to oversee them.
The study at the FDA's National Center for Toxicological Research (NCTR) used squirrel monkeys to gauge how various levels of nicotine affect the risk of addiction in teens and young adults.
No new studies will begin at the NCTR until the investigation is complete, FDA Commissioner Dr. Scott Gottlieb said. The surviving monkeys will be placed in a permanent sanctuary home, he added.
"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," Gottlieb said in a statement.
After learning about the monkey deaths and other concerns, Gottlieb said he immediately stopped the study. He also asked the FDA's Principal Deputy Commissioner to lead a review of the well-being of animals involved in the study and the circumstances surrounding the four deaths.
Gottlieb also ordered an independent, third-party probe of all of the FDA's animal research programs.
A new Animal Welfare Council will oversee all animal research studies and facilities under FDA control. It will advise the FDA on its approach to animal welfare and ensure animal studies meet the agency's standards, according to the statement.
The FDA will also "reaffirm and strengthen our commitment to replacing, reducing, and/or refining animal studies," Gottlieb said.
He added, however, that there remain many areas where animal research is important and necessary.
"We understand and share concerns that animals be involved in research only when there is no other way to fulfill an important public health objective. And, when these studies are necessary, the animals involved in research must be cared for under strict, humane guidelines," Gottlieb stated.
"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," he concluded.
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