FDA to Stem Cell Clinics: File an IND by June 1, or Close Business
(Thursday, April 29, 2021)
For several years, stem cell clinics in the US have flourished offering treatments to patients for all kinds of ailments, despite the FDA warning that these treatments are illegal under the US regulations. That ends on 1st June 2021 when FDA will finally initiate aggressive enforcement actions against such clinics, announced FDA’s Director for the Center for Biologics last week. Stem cells derived from various human sources such as body fat, bone marrow, and placental tissue, have been reported to be the panacea of all ailments. Thousands of peer-reviewed publications, many of them in highly credible journals, have reported benefits of human sourced stem cell treatments in diverse indications such inflammatory diseases, joint treatments, neurological disorders, and sports injuries. However, there have been few clinical trials under IND applications, and no formal approvals in the US for such treatments. Physicians and developers have often argued that human sourced stem cell-enriched products meet the definition of human cell, tissue, and cellular and tissue-based products (HCT/Ps) that do not need formal approval under PHS 361 (also called 361 Products). However, FDA has repeatedly countered that PHS 361 is not applicable to these stem cells and that these treatments are regulated under PHS 351, which need clinical trials under IND applications and market approval under BLA applications. The industry disagrees, of course, leading to numerous back-and-forth. Meanwhile, as the controversy continued, stem cell companies have continued to offer these treatments to patients willing to pay hefty out-of-pocket costs in the name of no available alternate treatment to patients. The stem cell industry lobbies hard and has political support in some states. By unofficial counts, more than a million people have been treated with such stem cell products in the last 10 years. Few safety issues have been reported but FDA argues that since these treatments have not been reviewed by its reviewers, they pose unreasonable risk to the patients who get these treatments. Since 2012, FDA has announced numerous times its desire to force stem cell companies to either conduct clinical trials under INDs and pursue BLAs, or close their business. To allow existing businesses time to comply, FDA offered time-bound enforcement discretion so they could discuss with FDA and prepare their INDs, while gradually moving patients from treatments to their clinical trials. The enforcement discretion timeline was moved a few times for various reasons, the last extension was in November last year due to pandemic related delays when the final deadline for enforcement was set at 31st May 2021. Last week, FDA announced that the 31st May deadline will not be extended any further and starting 1 June anyone who still hasn’t have a meeting with the FDA or filed an IND, should be prepared to see FDA at its doors with mandate to lock down and take other punitive actions. FDA is serious this time, the stem cell companies need to be as well. With only about 4 weeks to the deadline, if a company has not initiated the process yet, they will need to wind down their operations. Filing IND(s) quickly before the deadline is another option.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC