VANCOUVER, BC , Oct. 3, 2024 /PRNewswire/ - The International Society for Cell & Gene Therapy (ISCT) celebrates a major legal victory in the ongoing fight to protect the public from unregulated cell and gene therapies. In U.
S. v. California Stem Cell Treatment Center, Inc.
, the U.S. Court of Appeals for the Ninth Circuit ruled in favor of the U.
S. Food and Drug Administration (FDA), reversing the district court decision. This ruling confirms the U.
S. FDA's authority to regulate cell therapies, ensuring that the safety and effectiveness of products being offered to patients are properly evaluated through an established regulatory framework. ISCT, which has championed the critical importance of adhering to rigorous scientific, clinical, and ethical standards and regulation, had filed an amicus curiae brief in June 2024 to support the U.
S. government's appeal of the district court decision. The Society's involvement in this case comes in the context of a rapidly growing cell and gene therapy market which has led to an increase in the number of clinics promoting unregulated and unauthorized therapies to vulnerable patients.
ISCT is committed to providing its leadership and expertise, ensuring that important decisions bridging science, regulatory, and policy, are well-informed and for the benefit of the public. Bruce Levine , Chair of the ISCT Ethics of Cell and Gene Therapy Committee (ECGT), praised the decision: "This ruling is a major step in reaffirming the U.S.
FDA's central .