Washington Update

Federal Support for Fetal Tissue Research Scrutinized

By: Jennifer Zeitzer
Thursday, December 20, 2018

In September, the Department of Health and Human Services (HHS) initiated a comprehensive review of federally supported research involving fetal tissue “to ensure the adequacy of procedures and oversight of this research in light of the serious considerations involved.”

An HHS announcement indicated that fetal tissue acquisitions would be reviewed to ensure conformity with procurement laws and regulations, and whether alternatives to the use of human fetal tissue in HHS-funded research have been adequately explored. HHS also expressed interest in funding and accelerating development of alternative models to reduce the use of fetal tissue.

The department’s actions followed the cancellation of a contract between the U.S. Food and Drug Administration and Advanced Bioscience Resources, Inc., to provide human fetal tissue for developing testing protocols. HHS officials explained they did not feel assured that the contract “included the appropriate protections applicable to fetal tissue research or met all other procurement requirements.”

Following that announcement, senior HHS staff hosted a series of listening sessions to gather input from stakeholders. Scientists who use fetal tissue in research and representatives from scientific organizations, professional societies, major research universities, and patient groups participated in meetings with HHS in late November. FASEB was invited to provide feedback to HHS.

The majority of the listening session discussions focused on specific examples of research involving fetal tissue, the existence of adequate alternative models, and accelerating the development of alternative models. Following the meetings, HHS gave stakeholders an opportunity to provide more information on disease-specific advances involving fetal tissue research.

A series of subsequent news articles has led to confusion about the status of federally supported fetal tissue research. On December 5, the Washington Post reported a National Institutes of Health (NIH) decision to cancel a contract with the University of California San Francisco (UCSF) involving the procurement of fetal tissue. HHS disputed the article’s accuracy, issuing a statement that said “a decision will be made when the contract has been reviewed, pursuant to the ongoing audit/review process. There is a provision for continuity of work while the contract is being reviewed.” Science then published a copy of the letter from NIH to UCSF, confirming the contract’s extension for 90 days with no guarantee of  an extension beyond that.

A second Washington Post article published December 9 quoted a senior scientist at a NIH-funded intramural lab in Montana telling colleagues that HHS “has directed me to discontinue procuring fetal tissue.” Responding to the newspaper, an HHS spokesperson said NIH did not halt any intramural research projects and clarified that when the review began in September, NIH paused procurement of new human fetal tissue within its intramural program until the conclusion of the audit. Research with tissue already on hand could proceed, and NIH leaders asked intramural investigators to notify them if new procurement would be necessary. HHS added that officials would investigate why the lab mentioned in the Washington Post article was not notified.

Although it is not clear when HHS will conclude its review, HHS Assistant Secretary for Health Brett Giroir, MD, reiterated that no decisions have been made about the continued use of fetal tissue in federally funded research. He also acknowledged HHS’s awareness of concerns surrounding the process, adding, “I would tell the scientists: Don’t overreact. We’ve met with multiple groups. We are being transparent around this. The science part is being run by scientific people.”

Simultaneously, NIH issued a Notice of Intent to publish funding opportunity announcements for research to develop, demonstrate, and validate experimental human tissue models that do not rely on human fetal tissue. NIH expects to invest up to $20 million in FY 2019 and 2020 in this line of research.

As HHS continued its internal deliberations, two House Government Reform and Oversight subcommittees held  a joint hearing to explore alternatives to fetal tissue research. The session featured testimony from David Prentice, PhD, and Tara Sander Lee, PhD, of the Charlotte Lozier Institute, who recently spoke at a forum on alternative models hosted by the Heritage Foundation. Both argued that  there is no scientific justification for continuing to allow federal funding for fetal tissue research and that alternatives not requiring the procurement of fresh tissue exist.

A third witness, Sally Temple, PhD, former President of the International Society for Stem Cell Research, refuted the idea that fetal tissue research could be replaced by alternatives. She outlined the unique properties of fetal cells that cannot be easily replicated by other methods.

FASEB and several FASEB member societies were among the 60-plus scientific, medical, and patient groups who signed-on to a letter sent to the Oversight and Government Reform Committee prior to the hearing. The letter supported Dr. Temple’s testimony,  offered examples of medical advances stemming from the use of fetal tissue, and noted the rigorous ethical and regulatory framework governing its use.