The FDA warned Genetech and its president Edwin Pinos for manufacturing stem cell products without FDA approval and deviating from current good manufacturing practice requirements, which may have led to microbial contamination.
Here are nine things to know:
1. The FDA inspected Genetech’s facility in June and found the company was processing cellular products from human umbilical cord blood for intra-articular joint injection, intravenous injection or application directly to the affected tissue to treat a variety of orthopedic conditions.
2. Liveyon then distributed the umbilical cord blood-derived products as ReGen5, ReGen10 and ReGen30.
3. The Genetech products are not intended for homologous use or allogeneic use in a first- or second-degree blood relative. They are regulated as both drug and biological products. To lawfully market these products, an approved biologics license application is required; while in development, they may be used in humans only if an investigational new drug application is in effect. No licenses or investigational new drug applications exist for the Genetech-processed Liveyon-distributed products.
4. During the inspection, the FDA identified deviations from best practices, including deficient donor eligibility practices, unvalidated manufacturing processes, uncontrolled environment, lack of control over the components used in production and a lack of defined areas or control system to prevent contamination and mix-ups. These deviations may lead to microbial contamination or serious product quality defects.
5. The FDA and CDC are aware of 12 patients who received Genetech products from Liveyon and became sick due to blood and other infections caused by bacteria.
6. In September, Liveyon suspended shipment of all product pending an FDA investigation into the source of the adverse reactions. Liveyon voluntarily recalled all Genetech products it may have distributed.
7. The FDA requested a response from Genetech within 15 working days of the letter’s issuance, detailing how the deviations described in the warning letter will be corrected. Uncorrected deviations could lead to seizure, injunction or prosecution.
8. The FDA is sending letters to reiterate its compliance and enforcement policy to other stem cell treatment manufacturers and providers.
9. The FDA plans to crackdown on unsubstantiated and poor quality stem cell therapies in 2019.
Here is the warning letter.