The Food and Drug Administration (FDA) recently issued a warning to Akan Biosciences, a Maryland-based company, regarding their allogenic, adipose-derived stromal vascular fraction (SVF) product, known as Ayama. This warning highlighted the fact that the product must be regulated as a drug and a biologic, as opposed to the more lenient category it was previously being marketed under. This move by the FDA has sparked conversations within the regenerative medicine community and raised concerns about the safety and efficacy of such products.
Dr. Paul Knoepfler, a stem cell biologist at the University of California Davis, noted that allogeneic SVF products are not commonly seen in the market. Most SVF products are autologous, meaning they are derived from the patient’s own tissues. This unique aspect of Akan Biosciences’ product raised eyebrows within the industry and likely contributed to the FDA’s decision to issue a warning to the company. The unusual nature of the product, combined with the violations of current good manufacturing practices, brought it under the FDA’s regulatory scrutiny.
The warning letter sent by the FDA to Akan Biosciences outlined several compliance issues with the Ayama product. These included the failure to screen donors for communicable diseases, a lack of adherence to CGMP requirements, and the improper classification of the product under the 351 pathway of the Public Health Service Act. The FDA found that the processing of the product altered its original characteristics related to its utility for reconstruction, repair, or replacement, which disqualified it from being classified under the 361 pathway.
During an inspection in September 2022, the FDA discovered multiple violations of CGMP by Akan Biosciences, including the failure to adequately screen donors for diseases such as HIV and hepatitis C and B. Additionally, the agency found issues with the donor screening form used by the company. In response to the FDA’s findings, Akan Biosciences initiated a voluntary recall of the Ayama product in September 2022. However, the FDA deemed the company’s response to be inadequate, further emphasizing the seriousness of the violations.
The warning issued to Akan Biosciences is part of the FDA’s broader crackdown on unapproved regenerative medicine therapies. Since 2021, the agency has been working to bring these products into regulatory compliance, including birth tissue products, stem cell products, orthobiologics, and exosomes. Manufacturers of such products are now required to meet premarket approval criteria or conduct research under the FDA’s investigational new drug (IND) requirements.
The FDA’s warning to Akan Biosciences regarding their allogenic SVF product Ayama underscores the importance of regulatory compliance in the field of regenerative medicine. The unique nature of the product, combined with the violations of CGMP and FDA regulations, brought the company under regulatory scrutiny. Moving forward, it is crucial for companies in the regenerative medicine industry to adhere to the highest standards of safety and efficacy to ensure the well-being of patients and compliance with regulatory authorities.