An MBA in Regulatory Confusion

  • by: Peter Pitts |
  • 07/31/2023
Welcome to the world of therapeutic use of tissues – an exciting and evolving arena of 21st century medicine and one of the many areas of medical products regulated by the FDA. And, as with many other areas of the agency’s jurisdiction, peculiar bureaucratic intervention and lack of clarity are causing harm to patients and costing American jobs.

Witness the Twilight Zone-like predicament of one company’s bizarre interactions with the FDA. The company is Regenative Labs. They manufacture (among other products) Wharton's Jelly Tissue Allografts. Wharton’s Jelly is human connective tissue used to repair, replace, or supplement missing, damaged, or non-properly functioning tissues.

The FDA’s job is to ensure its manufactured according to the agency’s current Good Tissue Practice (cGTP) guidance. Here’s Clue Number One: Wharton’s Jelly isn’t regulated as a drug, but as a tissue because … that’s what it is. Here’s the detail: As defined in 21 CFR 1271.3(c), “homologous use” means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with human cells, tissues, and cellular and tissue-based products (HCT/P) that perform the same basic function or functions in the recipient as in the donor. Remember “homologous use,” as it comes into play shortly.

On March 21, 2022, the FDA undertook a routine inspection of the Regenative Wharton’s Jelly manufacturing facility in Pensacola, Florida.  All FDA-registered facilities like Regenative’s are subject to regular routine inspections. At the end of the inspection, the FDA reported certain observations to the company via a 483 letter each of which the Company addressed and remediated within about 30 days. On October 5, 2022, Regenative Labs asked the FDA for a standard export certificate so they could send Wharton’s Jelly tissue to foreign clients. That standard request was denied and here’s where it gets confusing.

Regenative Labs had previously applied for and received an export certificate for its amniotic membrane patches -- manufactured in the same lab as the Wharton Jelly products. Strangely, the initial ongoing inspectional review was not an issue for the patches; yet it was the agency’s basis for not to issue the export certificate for Wharton’s Jelly. Another example of the FDA’s lack of regulatory reproducibility, costing companies time, money, and agita and patients access and affordability.

Then, in a June 21, 2023 letter, the FDA raised additional issues not related to product quality but product use, stating that the agency had decided to treat Regenative Labs’ Wharton’s Jelly as a drug rather than a tissue product, reinforcing its insistence on using the drug standards of current Good Manufacturing Practice (cGMP) rather than applying the tissue standard for Wharton’s Jelly -- current Good Tissue Practices. Confused yet?  Hang in there.

Remember “homologous use?” Per the FDA, “In applying the homologous use criterion, the FDA will determine what the intended use of the HCT/P is, as reflected by the labeling, advertising, and other indications of a manufacturer’s objective intent, and will then apply the homologous use definition.” Per the agency’s view on how the company was marketing its Wharton’s Jelly product, it was a drug and not a tissue product.

This is weird … and wrong since the what the FDA is claiming is contrary to the instructions for use expressly stated by the company. Regenative Labs materials are clear -- their Wharton Jelly products they are intended for homologous use only and in other marketing efforts, they incorporate the FDA’s definition of homologous use into their materials. The FDA is judge and jury in such matters and facts that contradict their position are often given short shrift.

What does this have to do with an export certificate? Nothing. And here’s Clue Number 2: The FDA doesn’t regulate the practice of medicine – except that’s precisely what it’s doing.

The FDA’s position put Regenative Labs is an awkward position. In fact, the FDA’s reclassification of Wharton’s Jelly from tissue to biological drug would make it impossible for any company manufacturing this tissue in the United States to remain in business -- eliminating a key tool for physicians and patients, further exacerbating the already increasing problem of medical product shortages, eliminating hundreds of high-paying jobs, and stifling corporate incentives to invest in continued product innovation.

The FDA’s treatment of the Regenative Labs Wharton Jelly situation raises many questions, not the least of which is – where’s senior agency management oversight? How does the reclassification of important tissue products to biological drugs happen without more adult supervision? You don’t need a Wharton MBA to recognize the danger of aggressive bureaucracy impacting the availability of Wharton’s Jelly, the viability of Regenative Labs, the loss Americans jobs and, most importantly, patient care.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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