The US Food and Drug Administration (FDA) is taking issue with Arizona-based Pinnacle Transplant Technologies for manufacturing a number of proprietary amniotic membrane-based products that FDA believes should be classified and approved as biologics.
Pinnacle, according to its website, currently manufactures and distributes morselized amniotic membrane-based products, which FDA says are intended to treat soft tissue injuries and inflammation, to cover and protect wounds or localized inflammation, and facilitate the migration and proliferation of the patient’s cells to the site of injury.
FDA says the products seem like human cells, tissues, and cellular and tissue-based products (HCT/Ps), but should actually be defined as biologics because of the way the company uses an unspecified process to alter “the original relevant characteristics of the structural tissue relating to the tissue’s utility for reconstruction, repair or replacement,” according to an untitled letter released earlier this week from Mary Malarkey, director of the Office of Compliance and Biologics Quality at the Center for Biologics Evaluation and Research (CBER).
The letter, like other untitled letters from FDA, indicates FDA’s initial correspondence to cite violations that do not yet require a warning letter.
Pinnacle says on its website that its processes meet FDA Current Good Tissue Practices (CGTP) guidelines, and that its products “are stored, processed and distributed under strict FDA regulations.”
Malarkey, however, notes that following review of the company’s website: “Your amniotic membrane-based products do not meet the homologous use criterion” set forth in two FDA regulations “because the labeling, advertising, or other indications of your objective intent collected during the inspection, indicate that these products are intended for general surgical indications as well as tissue repair and wound healing, which are not homologous uses of amniotic membranes.”
The company, which calls itself a multi-service tissue bank, also runs a Phoenix, Arizona-based 24,000-square foot processing facility with 10 validated cleanrooms, and “precision milling machines for processing machined specialty allografts.”
Russ Yelton, CEO of Pinnacle, told Focus: “We take this matter seriously and will be working with the FDA to address any concerns. Importantly, there has been no impact to patient safety through the distribution of these products, and the FDA’s inspection of our facility last year resulted in no ‘483’ inspectional observations.
“The interpretation of the regulations noted in the letter has been the subject of discussion over the last few years. We understand FDA will hold a hearing next year to obtain public input on the regulation of these types of products,” he added.
Draft Guidance on Homologous Use of HCT/Ps
The letter comes as CBER recently released new draft guidance on the homologous use of HCT/Ps, which will be useful for companies like Pinnacle.
That guidance lays out how homologous use is defined, what FDA means by the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues, what FDA means by a manufacturer’s “objective intent,” and other important information for companies developing HCT/Ps.
Untitled Letter from CBER
Draft Guidance on HCT/Ps