FDA to hold public meeting on human germline modification

The US Food and Drug Administration will next week hold a public meeting to discuss ‘oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease’. This will be the first public meeting ever held by the FDA to consider a form of human germline modification - inheritable genetic changes made to eggs, sperm or embryos.

If the FDA were to approve a human clinical trial of oocyte modification, it would be the first time any jurisdiction in the world has authorised intentional genetic modification of children and their descendants. But a sign-on letter calls on the FDA “not to allow the techniques under consideration to move to human clinical trial … because of the profound safety, efficacy, policy and social problems they would pose”. The technique carries a range of predictable and unpredictable risks for any resulting children and for future generations.

“We question the ethics of bringing children into existence by experimental techniques that have had developmentally poor outcomes in studies using both animal and human oocytes,” the letter states. “We are also concerned about the contravention of widespread prohibitions against human germline genetic modification that approval of clinical trials would represent, and about the possible precedent such approval could set for additional human germline modifications.”

The letter was prepared and circulated by the Center for Genetics and Society and the International Center for Technology Assessment, a project of the Center for Food Safety, and has been sent to the FDA. It has received more than 250 signatures from 13 different countries, 42 states and diverse professions and interests. According to Dr Marcy Darnovsky, executive director of the Center for Genetics and Society, this “speaks to the widespread concern about efforts to genetically engineer humans”.

The FDA meeting will not consider what its briefing document recognises as “ethical and social policy issues related to genetic modification of eggs and embryos” that “have the potential to affect regulatory decisions”, as it puts these issues “outside the scope of this meeting”. The Center for Genetics and Society noted that none of the FDA committee members are social scientists, bioethicists or policy experts; nor does the committee include public interest advocates, women’s health advocates or children’s advocates.

“We commend the FDA for holding a public meeting and inviting public comments on this controversial issue,” Darnovsky said. “But narrowing the deliberations - and the deliberators - this way means that key concerns will be difficult or impossible even to raise.”

Some 40 countries, including many with robust biotechnology and biomedical sectors, have adopted laws to prohibit human germline modification. The FDA’s decision could thus break “a long-standing international consensus against producing genetically engineered humans”, according to Darnovsky, with a “biologically extreme procedure that puts any resulting children at serious risk”. It was further noted that the US does not have any laws in place to regulate the usage or safety of the techniques.

“Its developers defend oocyte modification as a way to allow a small number of women who are affected by a rare form of mitochondrial disease to have an unaffected and mostly genetically related child,” said Darnovsky. “But there are safer alternatives available for these few at-risk people.” One such method is preimplantation genetic diagnosis (PGD), stated in the letter as “proving to be effective for screening embryos resulting from in vitro fertilisation to identify those with low risk”.

The meeting will be held on 25 and 26 February. For more information, click here.