The FDA is prohibited from going germline image

Science, August 5, 2016
I. Glenn Cohen (Faculty Director) and Eli Y. Adashi


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Petrie-Flom Faculty Director I. Glenn Cohen has co-authored a new article in Science magazine addressing recent legislation preventing the FDA from approving any research "in which a human embryo is intentionally created or modified to include a heritable genetic modification." From the article

A potentially renewable provision of the Consolidated Appropriation Act of 2016 forestalling the prospect of human germline modification was signed into law on 18 December 2015 (1). The provision, also known as a rider (an amendment extraneous to the main purpose of the bill to which it is attached), stipulates that “none of the funds made available by this Act [to the FDA] may be used to review or approve an application for an exemption for investigational use of a drug or biological product… in which a human embryo is intentionally created or modified to include a heritable genetic modification” (1). Destined to expire at the conclusion of this fiscal year (30 September 2016), the rider has since been incorporated yet again into the House and Senate appropriation bills for the fiscal year ending 30 September 2017 (2, 3). Subject to ongoing annual renewal, this congressionally legislated ban undermines ongoing conversations on the possibility of human germline modification, its likely distant time horizon notwithstanding (4). Also affected are ongoing efforts of the FDA to review the prevention of mitochondrial DNA diseases through germline modification of human zygotes or oocytes at risk (5).

A draft version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2016 in the House contained the rider, whereas the Senate version did not (6, 7). The final version of the merged House and Senate bills, the Consolidated Appropriations Act of 2016 (H.R. 2029), inclusive of the rider, contained last-minute additions, stipulating that germline-modifying Investigational New Drug (IND) applications “shall be deemed to have not been received by the Secretary [of Health and Human Services]” (1, 8). Indispensable to the intent of the rider, the added language precludes the unintended consequence of forbidding the FDA from responding to (and blocking) an IND application, which would have allowed such applications to be approved automatically within 30 days of submission.

As a practical matter, it might have been hard for the rider to have succeeded as a stand-alone bill. The rider might never have been voted out of committee, given that it lacked the urgency of a “must-pass” bill and might have been the subject of opposing arguments and hostile amendments. A presidential veto, a real possibility in the case of a stand-alone bill, is far less likely in the context of a rider to an omnibus bill (in the absence of line-item veto authority), because the failure of the omnibus bill could cause a government shutdown. The omnibus bill containing the rider was the year-end $1.8 trillion Consolidated Appropriations Act of 2016without which the federal government would not have been funded for the duration of fiscal year 2016 (1).

Congressional concerns regarding germline editing have been articulated in a report (H. Rept. 114-205) accompanying the House appropriation bill (9). In one passage of the report, the committee states that “… researchers do not yet fully understand all the possible side effects of editing the genes of a human embryo” (9). The report goes on to note that “editing of the human germline may involve serious and unquantifiable safety and ethical issues” (9). Similar concerns were expressed during a congressional hearing on “The Science and Ethics of Genetically Engineered Human DNA” before the House Subcommittee on Research and Technology (10). In his opening statement, Chair Lamar S. Smith (R-TX) noted that “a recent report from China, where teams of researchers have begun to experiment with engineering DNA in human embryos, is alarming” (10). Chair Smith went on to say that “most of the scientific community members have been clear: the science and ethics of this new technology must be resolved in order to prevent dangerous abuses and unintended consequences” (10). Finally, Chair Smith offered that a recent Science article authored by prominent thought leaders “recommended a moratorium on further research, while creating public forums for scientists, ethicists and policy makers to discuss the attendant ethical, social, and legal implications of genome modification” (10, 11).

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bioethics biotechnology fda genetics health care finance health law policy human tissue i. glenn cohen pharmaceuticals public health regulation research research funding stem cells