Legal Restrictions on the Use of Mitochondrial Replacement Techniques to Introduce Donor Mitochondria into Reproductive Cells
The increasing technical possibilities and the fast development of scientific methods enable more an more complex biological products and therapies - especially in the field of human cells and tissues. For such new methods, technologies and products, the legal responsibilities and requirements must be fixed and explained sometimes. Therefore, the FDA has published the "Advisory on Legal Restrictions on the Use of Mitochondrial Replacement Technieques to Introduce Donor Mitochondria into Reproductive Cells Intended for Transfer into a Human Recipient" on 4 August - stating:
"The Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research regulates an array of diverse and complex biological products, both investigational and licensed, including human cell and gene therapy products and human cells and tissues. FDA’s oversight includes ensuring that human cells and tissues intended for transfer into a human recipient, including reproductive cells and tissues, are free from infectious diseases.
Mitochondria contain a small amount of genetic material (DNA) that is separate from the DNA in the cell’s nucleus. The mitochondrial DNA is passed down only from mother to child, and thus is inherited differently from the nuclear DNA. Mitochondrial Replacement Technology (MRT) using donor mitochondria represents a possible treatment for mitochondrial disorders, but introduces a genetic modification and raises safety concerns.
The clinical use of MRT in the United States falls within FDA’s regulatory authority. Since December 2015, Congress has included provisions in annual federal appropriations laws that prohibit FDA from accepting applications for clinical research using MRT. Therefore, clinical research using MRT in humans cannot legally proceed in the United States. FDA maintains the authority to investigate and take enforcement action in the event that it becomes aware of noncompliance with the laws and regulations administered by FDA."
Source: "Advisory on Legal Restrictions on the Use of Mitochondrial Replacement Technieques to Introduce Donor Mitochondria into Reproductive Cells Intended for Transfer into a Human Recipient"
Related GMP News
16.04.2025FDA Warning Letter: Unauthorised Distribution of Fecal Microbiota Transplant Products
16.04.2025Development of a Risk-based Quality System for CMC R&D Laboratories in Drug Development
03.04.2025European Pharmacopoeia Commission Adopts First General Texts on mRNA Vaccines
03.04.2025FDA Warning Letter: Unlicensed biological Product, Misbranding and many other Offences
02.04.2025FDA Warning Letter: Unauthorized Drugs and Biological Products