Dear Ms. Dapolito:
I am writing to request permission to make an oral presentation during the October 22-23, 2013, public meeting of the Cellular, Tissue and Gene Therapies Advisory Committee of the FDA to discuss “oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility.”
I am a member of Mothers for a Human Future, a nonprofit initiative focused on promoting awareness, advocacy, and activism on new human biotechnologies that could alter the human species. My presentation will be no more than seven minutes.
I will speak from a mother’s point of view about issues of safety and efficacy, the lack of public awareness about this issue and its implications, and the need for a global moratorium on the use of any and all forms of inheritable genetic modification (IGM) to allow for international public education, conversation, and decision-making on the appropriate global regulatory framework for IGM. Because it could fundamentally alter the human species, there is a long-standing international norm prohibiting the use of IGM. No one country should unilaterally violate that norm.
At Mothers for a Human Future, we are particularly concerned about the lack of public knowledge and debate about potentially consequential technologies such as “oocyte modification,” which could open the door to the use of other forms of IGM. We have been working to raise the level of awareness among mothers, fathers, and advocates for children in the United States and Europe. Our founder and director Enola Aird has recently made presentations on this issue to a Global Summit on Childhood, the Alliance for Childhood European Network Group, and the Working Group on the Quality of Childhood at the European Parliament. We have asked the Parliamentary Assembly of the Council of Europe and the Bioethics Intergroup of the European Parliament to call for a global moratorium on the use of IGM.
As a result of her presentation to the Working Group on Childhood at the European Parliament, Ms. Aird has been invited to address the Bioethics Intergroup of the European Parliament on October 23 and 24, which is why she will not be able to make our presentation to the FDA Committee on October 22-23.
I look forward to the opportunity to present Mothers for a Human Future’s views on this crucial issue. We have developed a Mother’s Alert on the matter, which can be found here: /three-parent-babies-why-we-need-a-global-moratorium-now/. Our appeal to the Parliamentary Assembly of the Council of Europe can be found here:http:/ mothersforahumanfuture.com/mfhfs-appeal-to-pace/
Thank you and I look forward to hearing from you.