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FDA points out unapproved products
SILVER SPRING, Md.—The U.S. Food and Drug Administration (FDA) has warned Liveyon Labs Inc. and Liveyon LLC, of Yorba Linda, Calif., and their president and chief executive officer, Roya Panah and John W. Kosolcharoen, for processing and distributing unapproved products derived from umbilical cord blood.
Liveyon has also been warned regarding significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices, inadequate aseptic practices to prevent contamination, and deficient environmental monitoring. These deviations create potential significant safety concerns that put patients at risk. The companies’ unapproved products derived from umbilical cord blood are PURE and PURE PRO.
In addition to the warning letter issued to Liveyon earlier this month, the FDA sent untitled letters to RichSource Stem Cells, Inc., and Chara Biologics, Inc., for offering unapproved stem cell products to patients. The FDA also recently sent 20 letters to manufacturers and health care providers, pointing out that they may be offering unapproved stem cell products, and reiterating the agency’s compliance and enforcement policy.
“The FDA’s mission includes protecting public health by helping to ensure the safety and efficacy of medical products that patients rely on. The agency is aware that there are establishments who prey upon vulnerable populations by commercially marketing stem cell products with false and misleading claims about their effectiveness for treating serious diseases. The FDA is taking this action today because Liveyon Labs and Liveyon LLC failed to take appropriate measures to protect patient safety,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
“As evidenced by the number of actions that the agency has taken this month alone, there are still many companies that have failed to come into compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s regulations during the period in which the agency intends to exercise enforcement discretion for certain products with respect to FDA’s investigational new drug and premarket approval requirements, when the use of the product does not raise reported safety concerns or potential significant safety concerns. This period, which ends in November 2020, has allowed product manufacturers time to engage with the FDA to determine if they need to submit a marketing authorization application and, if so, seek guidance on how to submit their application to the FDA for approval,” Marks continued. “The agency continues to urge these manufacturers to engage with the agency about their regulatory requirements in the coming months.”
An FDA inspection of the Liveyon facility in May revealed that the companies were processing and distributing products derived from human umbilical cord blood for use in patients who were unrelated to the donors. Because these products are not intended for homologous use only, and fail to meet other criteria set forth in applicable FDA regulations, they are regulated as both drugs and biological products.
To lawfully market these products, companies need an approved biologics license application. While in the development stage, the products may be used in humans only if an investigational new drug application (IND) is in effect. However, no such licenses or INDs exist for the PURE and PURE PRO products marketed by Liveyon.
During the inspection, the FDA documented evidence of significant deviations from CGTP and CGMP requirements in the manufacture of the PURE and PURE PRO products, including deficient donor eligibility practices such as failing to screen donors’ relevant medical records for risk factors for communicable diseases; inadequate aseptic practices, such as failing to follow procedures to prevent microbiological contamination; and deficient environmental monitoring, such as failing to establish a system for cleaning and disinfecting the processing room and equipment.
These deviations pose a significant risk that the products may be contaminated with viruses or other microorganisms, or have other serious product quality defects which could possibly lead to patient harm.
The FDA has requested a response from Liveyon within 15 working days of the letter’s issuance that details how the deviations noted in the warning letter will be corrected. Deviations not corrected by the companies and responsible individuals could lead to enforcement action such as seizure, injunction or prosecution.
Health care professionals and consumers should report any adverse events related to treatments with Liveyon’s PURE or PURE PRO products or other stem cell treatments to the FDA’s MedWatch adverse event reporting program.
The FDA has also issued a safety alert about exosome products. Certain clinics across the country, including some that also manufacture or market violative “stem cell” products, are now also offering exosome products to patients. The FDA’s safety alert informs the public, especially patients, health care practitioners and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes.
These reports were brought to the FDA’s attention by the Centers for Disease Control and Prevention, among others, and the agencies worked with the Nebraska Department of Health and Human Services. The FDA is carefully assessing this situation along with its federal and state partners.