Fetal Tissue Research Is Back Under the Microscope at HHS

November 20, 2018

The Trump administration is moving forward on an audit that could threaten funding for biomedical researchers who are working with cells derived from human fetal tissue to develop treatments for conditions like Parkinson disease and spinal cord injury.

The Department of Health and Human Services (HHS) scheduled a series of listening sessions on Nov. 16 with input from scientists, abortion opponents, bioethicists, and other stakeholders on the use of fetal tissue research.

The sessions are part of a department-wide audit on fetal tissue research “in light of the serious regulatory, moral, and ethical considerations involved,” an HHS spokesperson said in a Nov. 14 statement. The HHS-wide audit builds on another audit that ultimately led to the termination of a fetal tissue supplier contract with the Food and Drug Administration (FDA).

The move is a potential win for abortion opponent groups like Susan B. Anthony List that want a moratorium on all fetal tissue research. But any decision to terminate funding would be a blow to stem cell researchers, who say fetal tissue research has contributed to the development of vaccines and therapies that have saved millions of lives. The National Institutes of Health (NIH) estimates that it will fund about $95 million in human fetal tissue research in fiscal year 2019.

The HHS spokesperson declined to confirm whether NIH officials would be involved in the audit.

FDA Contract Already Terminated

The listening sessions will take place about seven weeks after the HHS ended a $16,000 contract between FDA and Advanced Bioscience Resources Inc., a fetal tissue supplier that has been linked to a controversial sting video involving Planned Parenthood.

The video produced by the anti-abortion group Center for Medical Progress claimed to show Planned Parenthood employees discussing violations of federal law related to fetal tissue donations, allegations Planned Parenthood denied.

The 2015 video led to a House investigation on fetal tissue research, an effort divided along party lines amid a move by Republicans to defund Planned Parenthood over its alleged sales of fetal tissue for research.

“HHS was not sufficiently assured that the contract included the appropriate protections applicable to fetal tissue research or met all other procurement requirements,” the HHS spokesperson said.

“As a result, that contract has been terminated, and HHS is now conducting an audit of all acquisitions involving human fetal tissue to ensure conformity with procurement and human fetal tissue research laws and regulations,” the department spokesperson said.

“In addition, HHS has initiated a comprehensive review of all research involving fetal tissue to ensure consistency with statutes and regulations governing such research, and to ensure the adequacy of procedures and oversight of this research in light of the serious regulatory, moral, and ethical considerations involved.”

The audit will also consider whether adequate alternatives to human fetal tissue exist.

Fairly Common Practice

Fetal tissue research is a fairly common practice in biomedical research, according to a report from the National Academy of Medicine. The academy report said this research “involves cells from dead fetuses that are harvested for the purpose of establishing cell lines or for use as transplantation material and other purposes.”

The International Society for Stem Cell Research (ISSCR) is one of the scientific groups was been invited to speak before the White House on Nov. 16, an ISSCR spokeswoman confirmed on Nov. 14 to Bloomberg Law. The group has opposed efforts to restrict this field of research.

Scientists working with fetal tissue use only ethically obtained cells from tissue that would otherwise be discarded if it were not used in research, the society said. “Research using fetal tissue has led to the development of vaccines such as those for polio, rubella, and measles,” the society said. It is currently being used to evaluate therapies for conditions including Parkinson disease, amyotrophic lateral sclerosis, and spinal cord injury.

Selected information in the "Pharmaceutical Science Update" is compiled from summaries and articles from Bloomberg BNA.

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