FDA Warns Companies Over Products Made With Amniotic Fluid

The FDA has sent warning letters to two companies regarding their amniotic membrane- and fluid-derived PalinGen products, charging they should be regulated as drugs and biologics.

One of the letters, addressed to Phoenix, Arizona-based Pinnacle Transplant Technologies’ president and chief executive officer Roger W. Rose, claimed the company distributed products derived from amniotic membrane and amniotic fluid to third-party distributors, healthcare professionals, and medical facilities around the country. It added that some of those products were under private label and all were “intended for injection and are purported to be sterile.”

The agency explained that since these products are “intended for use in the cure, treatment, or prevention of diseases or conditions, such as wound healing, and/or are intended to affect the structure or function of the body” they are considered to be drugs under section 201 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and biologics under section 351 of the Public Health Service Act (PHS Act).

Drugs and biologics are subject to stricter regulations, the FDA warned in its letter.

The second letter, addressed to Phoenix, Arizona-based Amnio Technology’s chairman Merrill B. Stromer, detailed similar violations related to the FD&C Act and PHS Act, since the company also distributed similar products derived from amniotic membrane and amniotic fluid.

Notably, Stromer is also listed as a founder of Pinnacle Transplant Technologies on the company’s website.

Beverly Bliss, an executive vice president at Pinnacle Transplant Technologies, told MedPage Today in an email that Pinnacle Transplant Technologies “is a contract manufacturer for Amnio Technology LLC.”

The FDA charged that Amnio Technology has also promoted its products for wound healing, and said the company advertises these products as containing amniotic tissue, which it describes as “a rich source of various biologically active factors involved in tissue regeneration and wound healing with reported anti-inflammatory, anti-bacterial, re-epithelialization, and anti-fibrotic properties.” The company reportedly also claimed amniotic fluid “possesses anti-inflammatory, anti-microbial, and regenerative properties that make it attractive for use in clinical applications.”

The FDA noted that neither company has completed the necessary application to lawfully market a drug that is a biological product and that the PalinGen products sold by both companies are unapproved drugs.

In addition, the agency explained that the PalinGen products fail to meet the “minimal manipulation” and “homologous use” criteria that would allow them to be categorized as less restrictive human cell, tissue, or cellular or tissue-based products (HCT/P), which are regulated through section 361 of the PHS Act.

The agency also noted that both companies had “a number of significant [current good manufacturing practice] deviations” related to these PalinGen products, including failure to validate manufacturing processes, assigning expiration dates without adequate data, and failing to document consumer complaints.

Bliss said Pinnacle has taken the claims in the letter “very seriously” and “is committed to ensuring compliance with all federal regulations.”

She added that the company has “addressed the concerns in the letter with immediate actions taken to comply with those concerns.” She also noted that the company intends to “cooperate fully with the FDA.”

These warning letters are the latest in a series of FDA efforts to crack down on companies selling birth-tissue-derived products. Earlier this year, the agency warned a company for producing products derived from human amniotic fluid and umbilical cord, which the agency called unapproved drugs.

On a related front, a recent ruling from the 9th Circuit Court of Appeals gave the FDA authority to regulate adipose-derived stem cell treatments, also known as stromal vascular fraction, as a drug. Not long before that decision, the agency warned a company producing adipose-derived stem cell treatments.

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