FDA Meeting on Mitochondrial Replacement Rescheduled
The FDA public meeting to discuss mitochondrial replacement that was postponed due to the government shutdown in October has now been rescheduled for February 25-26. This will be the first public meeting ever held by the FDA to discuss the feasibility and desirability of a form of human inheritable genetic modification.
The meeting will be held by the Cellular, Tissue, and Gene Therapies Advisory Committee and in their words, it will consider “oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility.”
No official background materials have yet been published and may not be until just two days before the meeting. However, the FDA is encouraging public participation. Written comments may be submitted before February 18 to Gail Dapolito or Rosanna Harvey. Requests to make formal oral presentations may be submitted before February 10. If you previously submitted comments for the October meeting, I have been assured that they will carry over and be considered for the February meeting. Previous requests to speak should be confirmed. For those who cannot attend the meeting in person, a webcast will be available for both February 25 and 26.
CGS has written a detailed letter to the FDA to voice concerns regarding the safety, efficacy, and policy implications of allowing clinical trials of a technique under consideration.
For more information about the meeting, see this Biopolitical Times post; for more information about broader concerns with the technology, see these Huffington Post and Nature articles.
Previously on Biopolitical Times: