The U.S. Food and Drug Administration (FDA) sometimes gets lost in a bureaucratic maze of confusion and red tape that deprives patients of beneficial therapies. Innovative products sometimes fall within a gray area and become overly regulated. One of the FDA’s latest targets is regenerative medicine.
An article titled, An MBA in Regulatory Confusion, talks about Florida-based Regenative Labs. The firm manufactures products made from umbilical cords (donated by mothers after a C-section, according to the company website). English physician and anatomist Thomas Wharton first described his namesake umbilical cord jelly in 1656, although he had no way of knowing it is rich in stem cells and regenerative healing properties.
Medical products made from Wharton’s Jelly include a tissue matrix used to regenerate damaged tissue and heal injuries. Tissue products are usually regulated under what’s known as current Good Tissue Practice. By contrast, drugs and medical devices fall under current good manufacturing practices, which is a different standard for product manufacturing. Drugs also require submission and approval after clinical studies.
Regenative Labs sells its products to physicians, clinics and customers abroad. The manufacturer was recently denied an export certificate for its tissue jelly. The reason: FDA had decided to reclassify tissue jelly as a biological drug rather than a form of jellied tissue cells used to repair damaged tissues. The FDA claims because the firm has to process the tissue material it is no longer a tissue and the directions for use do not qualify as homologous.
I could spend the next seven paragraphs trying to explain the meaning of homologous and how it applies to tissue jelly, but that’s really not the point. The real reason (in my opinion) the FDA decided to reclassify processed umbilical cord gelatin containing stem cells as a biological drug? Because nearly 70 million Baby Boomers are slipping into advanced age, the youngest of which turns 60 next year. Aging bodies wear out and healing slows. Millions of people are looking for the fountain of youth. There is no actual fountain hidden in Florida. Rather there are new advances in medical science emerging using stem cells, peptides and other molecules.
By the way, the FDA does not consider aging to be a disease, so drugs to reverse, repair or slow the aging process face a higher bar for approval. One method that holds promise to regenerate damaged tissue is therapies made tissues with growth factors and stem cells. As mentioned earlier, one source is generically called Wharton’s Jelly.
Cells in Wharton’s jelly express several stem cell genes, including telomerase. They can be extracted, cultured, and induced to differentiate into mature cell types such as neurons. Wharton’s jelly is therefore a potential source of adult stem cells, often collected from cord blood. Wharton’s jelly-derived mesenchymal stem cells may have immunomodulatory effect on lymphocytes. Wharton’s jelly tissue transplantation has shown to be able to reduce traumatic brain injury in rats.
The agency’s decision to make tissue jelly a drug (rather than a tissue), even though it’s made from tissue slows progress on many emerging therapies. This from Drugwonks:
…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.
Indeed, the point apparently is to put a stop to experiments outside of tightly controlled clinical studies. If you put “Wharton’s Jelly” and “FDA” into a search engine you will see where FDA has ordered numerous companies to stop selling regenerative products to physicians and clinics trying to help patients. Other correspondence from the FDA tries to warn patients to steer clear of regenerative medicine clinics using these products. The broader goal seems to be to shut down regenerative medicine clinics. The FDA is not authorized to regulate the practice of medicine, which is basically what it’s doing (but that’s another story for another day). An article in MedPageToday summarized the FDA’s position:
In guidance issued several years ago, he said, the FDA made it clear that any kind of biological product sold for non-homologous use would have to file a biologics license application and go through clinical trials.
The FDA is trying to impede the use of stem cell therapies until manufacturers have performed expensive clinical trials, taking decades and hundreds of millions of dollars. Patients will ultimately suffer while waiting.