Details in the FDA Warning Letter to Genetech
The November 19 FDA Warning Letter did mention the infections. It seems to arise solely from the June inspections, which were well before the CDC received the first disease report. Key points in the warning letter:
- The Genetech-Liveyon products are drugs and biologics, not cosmetics or consumer products. However, Genetech has not submitted any kind of FDA application, not even for an investigational new drug (IND) or a biologics license application (BLA), much less received approval to sell them.
- The collection and manufacturing processes FDA says it saw in its June 2018 Genetech inspections are shocking:
“Genetech’s deficient donor eligibility practices, unvalidated manufacturing processes, uncontrolled environment, lack of control of components used in production, such as the addition of [redacted as a trade secret], and lack of defined areas or a control system to prevent contamination and mix-ups, as described below, pose a significant risk that your products may be contaminated with microorganisms or have other serious product quality defects.”
“[S]ince operations began in mid-2017, Genetech has failed to document whether donors of umbilical cord blood are eligible. Neither you, Liveyon, nor your suppliers have determined donor eligibility for the umbilical cord blood used to manufacture your products.”
The letter goes on in 19 additional detailed paragraphs describing risky operations and operating controls, including failure to screen donors for Zika virus, using tests not approved by the FDA for a wide variety of other blood-borne diseases; inadequate cleaning, inadequate air controls in the manufacture and gowning rooms, and, “Your firm added non-sterile [redacted] to approximately [redacted] batches of your products between mid-2017 and June 2018. These [redacted] are labeled ‘For research use only.’”
The December 20 Letter to HCT/P Companies, the Press Release, and Their History
FDA’s December 20 letter called out “stem cell” companies (FDA’s language) among HCT/P processors and providers, and along with the press release that was also released that day, referred to a November 2017 policy announcement which included this paragraph:
“To give manufacturers time to determine if they need to submit an IND or marketing application in light of this guidance and, if such an application is needed, to prepare the IND or marketing application, for the first 36 months following issuance of this guidance FDA generally intends to exercise enforcement discretion … provided that use of the HCT/P does not raise … significant safety concerns.”
To benefit from “enforcement discretion,” HCT/P processors were supposed to meet with FDA to discuss whether their processed living cell tissues needed some type of application or approval, and if so, what data was needed to obtain it.
“However, thus far it does not appear as though many firms have taken FDA up on their offer,” said a January 16, 2019 article by attorney Mark. I. Schwartz in the FDA Law Blog published by the law firm Hyman, Phelps, & McNamara. Schwarz is a former Deputy Director for Compliance in the Center for Biologics Evaluation and Research (CBER), the office which enforces compliance with these products.
