U.S. Food & Drug Administration Issues Warning to Company for Marketing Dangerous Unapproved Stem Cell Products
By Kenneth M. Daly, Burg Simpson Associate
On November 29, 2018 the U.S. Food & Drug Administration (“FDA”) sent Genetech, Inc. a warning letter regarding the company’s processing and distribution of umbilical cord blood derived stem cell products. These products are sold by Liveyon LLC and include ReGen®5, ReGen®10, and ReGen®30, which are marketed to treat a variety of orthopedic conditions.
During a recent inspection of Genetech’s facility the FDA found evidence of significant deviation from the Current Good Tissue Practice and Current Good Manufacturing Practice requirements 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 a control system to prevent contamination and mix-ups
According to the FDA, these deviations pose a significant risk that the products may be contaminated with microorganisms or have other serious product quality defects. In fact, the FDA and the Centers for Disease Control and Prevention are already aware of at least 12 patients who received Genetech products and subsequently became ill due to blood or other infections. As a result of the FDA’s concerns, Liveyon has issued a recall of any Genetech products that it may have distributed and has secured a new manufacture for its products.
On December 20, 2018 the FDA issued another letter to all companies offering “stem cell” products marketed to treat a variety of diseases or conditions, reiterating the requirements and regulations that are applicable to these products. Stem cell products may be regulated differently depending on the method and purpose of use and the FDA is currently employing a risk-based approach to enforcement, accounting for how the products are being administered and the diseases and conditions for their use.
The FDA states that health care professionals and consumers should report any adverse events related to treatments with the Liveyon products, Genetech products, or other stem cell treatments to the FDA’s MedWatch Adverse Event Reporting program.
If you or a loved one have been injured as a result of one of the Liveyon products, Genetech products, or other stem cell treatments, contact one of the experienced product liability attorneys at Burg Simpson today to discuss your legal rights.