The major US government spending bill, agreed on Tuesday and set to be passed by Congress on Friday, includes a prohibition of the use of federal funds by the Food and Drug Administration to consider human embryos “intentionally created or modified to include a heritable genetic modification”. The use of new gene-editing techniques like CRISPR to edit human embryos was a major focus of a recent international summit, where scientists concluded that basic, but not clinical, research should be allowed to continue. GENeS has asked experts in biomedical law what restrictions the spending bill would put on research using gene-editing on human embryos.
Henry (Hank) Greely, Director, Center for Law and the Biosciences; Professor (by courtesy) of Genetics, Stanford School of Medicine (webpage):
Expertise: ethical, legal, and social implications of new biomedical technologies, particularly those related to neuroscience, genetics, or stem cell research.
“It’s important to note that the language of the spending bill is not just dealing with federally funded research, which is already excluded by another part of the bill. The language in the bill probably successfully prevents someone with private funding from transferring a genetically modified embryo into a woman’s uterus for possible birth. I do not believe it affects research in which a human embryo is ‘intentionally modified or created in order to include a heritable genetic modification’ if there is no transfer for possible implantation. That research is not ‘clinical’ research and does not involve administering the new ‘drug’, which is what the FDA would consider the embryo, to a human being. As far as I can tell, human embryos are not ‘human beings’ for purposes of FDA’s clinical responsibilities.
“Thus, I think the result is consistent with the conclusions of the organizing committee of the International Gene Editing Summit: no one will be able to do ‘clinical’ research that might cause the birth of a child during the one year term of this appropriations bill, but non-clinical research should be able to continue. And, again, for other legal reasons no federal funding can be used in either clinical or non-clinical research that destroys or puts at risk a human embryo.”
Alta Charo, Warren P. Knowles Professor of Law and Bioethics, University of Wisconsin – Madison (webpage):
Expertise: law and policy related to environmental protection, reproductive health, new reproductive technologies, medical genetics, stem cell research, science funding, and research ethics.
“As I understand it, FDA does not come into play and an investigational new drug application (IND) exemption is not needed, until there is a proposal to use the resulting altered product in a clinical trial. So purely in vitro work does not need FDA permission, and does not need to meet FDA’s good manufacturing practices requirements.
“If the data from such work is eventually used to support an IND application, then there may be some look-back by FDA on issues surrounding donor screening, good manufacturing practices, and underlying consents for the tissue donation before the agency will agree that the data can be used.
“There are other regulatory systems in place for basic research involving embryos. Research may still need institutional review board oversight if the gametes or embryo will provide information about identifiable donors, or if a person is asked to undergo gamete retrieval (egg or sperm donation) specifically for the research. It may require institutional biosafety committee review if recombinant DNA work is involved. And some embryonic stem cells research oversight committees (which are voluntary, not federal) have now started reviewing any and all research that uses a human embryo.”
Patricia Zettler, Associate Professor, Georgia State University College of Law (webpage):
Expertise: regulation of medicine, biotechnology and biomedical research, with an emphasis on the U.S. Food and Drug Administration.
“Generally research that involves the use of unapproved drugs and biologics, including gene therapies, in humans cannot go forward until the FDA authorizes an ‘investigational new drug application’ (IND) for that research. Section 749 of the bill would prevent the FDA from authorizing INDs for such research when the research involves creating or changing embryos to include a ‘heritable genetic modification.’ However, if the bill is intended to stop all research involving human germline editing, including privately-funded, non-clinical research (research in which no embryo is being transferred into a woman), I don’t think it accomplishes that goal. Because the FDA’s IND requirements apply only to research involving the use of products in humans, basic non-clinical research would not be not affected by the bill’s restrictions on INDs. And, given the support for proceeding with non-clinical research at the recent International Summit on Human Gene Editing, this seems like an appropriate result.”
Declared interests (see GENeS register of interests policy):
Patricia Zettler: “I served as an attorney in the FDA’s Office of the Chief Counsel from 2009 to 2013.”
No further interests declared