The US government has cancelled its US$15,900 contract with a company that supplies fetal tissue to researchers at the Food and Drug Administration (FDA). The Department of Health and Human Services (HHS), which oversees the FDA, is reviewing “all research involving fetal tissue” and “all acquisitions involving human fetal tissue”, it said on 24 September.
The FDA had awarded the one-year contract in July to Advanced Bioscience Resources (ABR), a non-profit tissue supplier in Alameda, California. According to the contract, FDA researchers would implant the human fetal tissue provided by the company into mice that lacked immune systems. The goal was to give the animals human-like immune systems, so that FDA researchers could use the mice to evaluate the safety and efficacy of various drugs.
In its statement, the HHS said that it cancelled the contract because it “was not sufficiently assured that the contract included the appropriate protections applicable to fetal tissue research or met all other procurement requirements”.
The government’s action comes after 85 members of the US House of Representatives sent a letter to FDA commissioner Scott Gottlieb on 17 September, claiming that ABR might have violated federal law by selling “the body parts of children” for a profit. In 2016, a special House committee — the Republican-led Select Investigative Panel on Infant Lives — had referred the company to the US Department of Justice for investigation. ABR did not immediately respond to Nature’s requests for comment.
“We are alarmed that the FDA has continued to award contracts to ABR for the procurement of human fetal tissue,” the lawmakers wrote to Gottlieb. “We urge you to cancel this contract immediately and to utilize alternative, modern scientific techniques that do not contribute to the trafficking in baby body parts.”
The HHS has offered little detail about its review of fetal-tissue contracts and research. In its statement, the department said that it is auditing “all acquisitions involving human fetal tissue” to ensure that firms that supply the tissue adhere to federal regulations.
The department has also begun reviewing all research involving fetal tissue “to ensure the adequacy of procedures and oversight of this research in light of the serious regulatory, moral, and ethical considerations involved”, as well as whether alternatives to fetal-tissue research exist. The HHS has not clarified whether its review will include all fetal-tissue research performed in the United States, or only that funded by the federal government.
Larry Goldstein, a neuroscientist at the University of California, San Diego, says that it’s hard to know why the HHS decided to cancel the contract. “I think the question is whether there’s an attempt to politicize this or whether we can keep to straight scientific and medical merit,” he says. “We support reasonable, non-politically motivated regulation.”
But he is concerned that a ban or heavy restrictions on federally funded experiments with fetal tissue could harm research, particularly on human development, organ regeneration and determining whether tissue created from stem cells recapitulates the real thing. Studies of fetal tissue “really can’t be replaced with animal research”, he says.
Goldstein adds that the fetal tissue used in research is material that would otherwise be discarded. “Scientists are simply asking, if you’re going to throw the tissue away anyway, can you at least donate it to important medical research?”
Renate Myles, a spokeswoman for the US National Institutes of Health (NIH), which sits within the HHS, says that the agency does not have any standing contracts with any providers of human fetal tissue. “We agree that it is important that research involving human fetal tissue should be consistent with the statutes and regulation governing such research, and reminded NIH-funded institutions that awards are conditioned upon compliance of all applicable federal, state, and local laws and regulations,” she says.
Nature 562, 16-17 (2018)