FDA Warns Company Over Amniotic Products

Federal regulators continue to crack down on birth tissue products, with the FDA sending a warning letter to Texas-based Stratus Biosystems over its amniotic membrane and fluid products, marketed under the Cell Genuity brand.

The agency said the company’s umbilical cord and amniotic membrane product (AmnioAMP-WJ) and its amniotic fluid product (AmnioAllograft) should be regulated as a drug under section 351 of the Public Health Service (PHS) Act. These products do not qualify to be regulated solely as human cell, tissue, or cellular or tissue-based products (HCT/P) under section 361 of the PHS Act, the agency said.

Specifically, the FDA said AmnioAMP-WJ does not meet “homologous use” criteria, as it “is not intended to perform the same basic function or functions of umbilical cord and amniotic membrane in the recipient as in the donor.”

As for the AmnioAllograft product, FDA said the definition of HCT/Ps excludes secreted or extracted human products, and thus amniotic fluid would not be considered an HCT/P.

The agency noted that neither product has an approved biologics license application (BLA) or an investigational new drug application (IND) in effect.

FDA also found, during an inspection of Stratus’ facility in Grapevine, Texas, in late October and early November 2021, evidence of deviations from current good manufacturing practices.

These included problems with its aseptic practices — that they had not been validated; that there were no written procedures for environmental monitoring in aseptic processing areas; and that there were no established procedures for the sterilization of the filter that comes into direct contact with both products during processing.

FDA also said there wasn’t an adequate system for cleaning and disinfecting the room and equipment to ensure aseptic conditions; nor did the company investigate some of its sterility and environmental monitoring failures.

Someone who answered the phone at Stratus Biosystems headquarters said the company had no comment at this time.

Cell Genuity products were also implicated in a recent case involving a Texas-based physician assistant, whom the Department of Justice (DOJ) charged with alleged healthcare fraud for giving injections of amniotic fluid for pain management — and most of those products were the Cell Genuity brand, DOJ said.

Ray Anthony Shoulders, PA, reportedly used a Medicare Q code for a similar product to charge Medicare for Cell Genuity shots, even though the federal payer does not reimburse for birth tissue injections, DOJ said.

The FDA has been coming down harder on so-called birth tissue companies. Earlier this month, the agency sent a warning letter to Regenative Labs of Pensacola, Florida, over its “Wharton’s Jelly” products.

FDA said Regenative’s products were unapproved drugs marketed to physicians and clinics for an unapproved use, as they did not meet homologous use or minimal manipulation criteria and thus would not be considered a 361 human tissue product.

The agency also found safety concerns during an inspection of Regenative’s production facility.