The US Food and Drug Administration (FDA) has sent a warning letter to Genetech, Inc in San Diego, California, over marketing "dangerous" unapproved stem-cell products and for "significant" deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements.
Some violations may have led to microbial contamination, potentially causing serious blood infections in some patients, the FDA announced today in a news release.
An FDA inspection of Genetech's facility revealed that the company was processing cellular products from human umbilical cord blood for administration by intra-articular injection, intravenous injection, or application directly to the affected tissue to treat a variety of orthopedic conditions. These products were distributed by Liveyon, a biotechnology company based in Yorba Linda, California, as ReGen5, ReGen10, and ReGen30.
The FDA and the Centers for Disease Control and Prevention (CDC) have received "numerous reports of safety issues" including those involving microbial contamination. The FDA said 12 patients who received Genetech's unapproved products from Liveyon subsequently became ill from blood and other infections caused by a number of bacteria, including Escherichia coli.
In late September, Liveyon suspended shipment of all product pending an inquiry by the FDA into the source of the adverse reactions. The company voluntarily recalled all Genetech products it may have distributed.
The FDA has requested a response from Genetech within 15 working days of receipt of the letter, with details on how the company plans to fix the problems uncovered.
"The FDA remains committed to taking action against products being unlawfully marketed and which pose a potential significant risk to patient safety at this time. However, the agency is also committed to ensuring that patients have access to safe and effective regenerative medicine products as efficiently as possible," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in the release.
"Time is Running Out"
Additionally, in its ongoing crackdown on unlawful stem-cell products, the FDA today sent letters to manufacturers, healthcare providers, and clinics around the country that offer stem-cell treatments, reiterating the agency's policy regarding human cell- and tissue-based products.
"The FDA is committed to advancing the field of cell-based regenerative medicine. We’re implementing new policies to make it more efficient to safely develop these promising new technologies. At the same time, we’re also focusing more resources on enforcement when we see companies skirt safety measures and put patients at risk," FDA Commissioner Scott Gottlieb, MD, said in the release.
The letters issued today "are a reminder that there’s a clear line between appropriate development of these products and practices that sidestep important regulatory controls needed to protect patients. Time is running out for firms to come into compliance during our period of enforcement discretion. We'll be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients," said Gottlieb.
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Cite this: FDA Warns Genetech Over Unapproved Stem-Cell Products Linked to Infections - Medscape - Dec 20, 2018.