{"id":388891,"date":"2023-12-19T12:50:30","date_gmt":"2023-12-19T17:50:30","guid":{"rendered":"https:\/\/platohealth.ai\/surprising-new-fda-remarks-to-aabb-on-cord-biologics-misuse-stem-cell-clinics-the-niche\/"},"modified":"2023-12-20T06:46:57","modified_gmt":"2023-12-20T11:46:57","slug":"surprising-new-fda-remarks-to-aabb-on-cord-biologics-misuse-stem-cell-clinics-the-niche","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/surprising-new-fda-remarks-to-aabb-on-cord-biologics-misuse-stem-cell-clinics-the-niche\/","title":{"rendered":"Surprising new FDA remarks to AABB on cord biologics misuse & stem cell clinics – The Niche","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
The Association for the Advancement of Blood & Biotherapies or AABB<\/strong> <\/a>recently had a very useful Q&A with the FDA on cord blood use. There are some important new things from the FDA on the marketing and use of cord blood in there.<\/p>\n The agency was also quite blunt in some ways about the challenges, while in others I think they overstated their effectiveness. Overall, it\u2019s one of the more useful recent windows into the FDA\u2019s thinking, which is not always easy to read.<\/p>\n Let\u2019s dig into a couple of the key questions and answers.<\/p>\n Note for reference that AABB used to stand for American Association of Blood Banks and it is still made up of many blood cell product bankers and manufacturers. Quite a few members specifically produce cord blood products and supply them to various customers. Cord biologics can also include MSCs<\/strong><\/a> or even Wharton\u2019s jelly<\/strong><\/a> from the wall of the cord.<\/p>\n The Q&A presentation, as part of the AABB annual meeting, included some excellent questions.<\/p>\n For example, AABB Q9 above:<\/p>\n \u201cAre we (the manufacturer\/distributor) responsible if the clinical facility decides to use the product off-label for nonhomologous use?\u201d<\/p>\n<\/blockquote>\n In other words, can good citizen cord blood manufacturers\/distributors get in trouble with the agency if their customers misuse the products?<\/p>\n The FDA answer here, in my reading, holds manufacturers and distributors somewhat responsible for only selling to customers who will use cord blood responsibly. That\u2019s a big ask. For example, it seems difficult for manufacturers and distributors to anticipate all possible future uses. Customers may also drift in focus and clinical intentions over time while still maintaining stock of frozen cord materials.<\/p>\n Admittedly, there have been some irresponsible cord product manufacturers\/distributors over the years who knowingly supply material to reckless clinics, but my impression is that these are the minority.<\/p>\n<\/div>\n<\/div>\n Also, what about the FDA\u2019s role in oversight of this space more generally? Shouldn\u2019t the agency be more effectively reining in most misuse after years of obvious noncompliant and even outright illegal usage? It\u2019s just not happening. Effective oversight would have made the jobs of good citizen manufacturers and distributors far more straightforward. Right now, instead, there are hundreds of firms misusing cord products including cord blood for profit.<\/p>\n Then there\u2019s Question 11:<\/p>\n Question 11: These so called \u201cclinics\u201d are misleading the general public and sowing misinformation. There appear to be hundreds locally, and thousands across the country. Please update us on what FDA is doing to address these \u201cclinics\u201d using cord blood and other cellular material inappropriately?<\/p>\n<\/blockquote>\n Here are excerpts of the FDA\u2019s answer and my comments\/notes.<\/p>\n \u201cIn August 2017, FDA announced an increase in its enforcement and compliance actions against purveyors of unapproved stem cell and related products. Since that time, FDA has engaged in continuous, collaborative efforts with the U.S. Department of Justice to pursue and support FDA\u2019s enforcement actions in federal district and appellate courts, including two injunctions and a seizure.\u201d<\/p>\n<\/blockquote>\n Note that while the FDA has increased enforcement actions specifically in the perinatal space overall, the two injunctions and seizure it mentions (while positive actions) were not related to cord blood or other birth-related products. Rather, they were related to adipose cell products.<\/p>\n The FDA goes on to note the letters it has sent to non-compliant firms:<\/p>\n In best-case scenarios, Warning Letters and Untitled Letters prompt individuals and companies to rectify violations and commit to complying with the law going forward.<\/p>\n<\/blockquote>\n Except the best-case scenarios also seem to be the rarest outcomes.<\/p>\n They get more specific about actions in the broader cellular biologics space:<\/p>\n Since August 2017, FDA has issued 28 Warning Letters involving stem cell or related products that violated the Public Health Service Act (PHS Act); the Federal Food, Drug, and Cosmetic Act (FD&C Act); and\/or their implementing regulations. FDA issued most of these letters following facility inspections; during these inspections, FDA investigators had documented significant violations of current good manufacturing practice requirements. In addition to the Warning Letters, FDA has issued over 40 Untitled Letters involving stem cell or related products since July 2018. Since December 2018, FDA also has issued over 600 letters to manufacturers, healthcare providers, and clinics in almost all 50 states who may be offering stem cell or related products. These letters notify recipients that they appear to be marketing a product that may be in violation of the PHS Act, the FD&C Act, and\/or their implementing regulations.<\/span><\/p>\n<\/blockquote>\n There are interesting new data in this answer.<\/p>\n Twenty-eight relevant warning letters in this area since mid-2017 seems like a very high number compared to what I\u2019ve seen on the FDA warning letter webpage when I search for relevant terms. Are some letters not in the public domain yet?<\/p>\n The 40 and 600 untitled and non-specified letters also reflect extensive correspondence between the FDA and clinics.<\/p>\n Are these hundreds of letters doing much good?<\/p>\n The FDA finishes answering this question with mixed messages (emphasis mine):<\/p>\n \u201cFinally, FDA has also been very active in promoting stakeholder education and outreach activities for patients, hospitals, healthcare practitioners, manufacturers, and clinics in this field.<\/p>\n While FDA\u2019s case-specific enforcement, compliance, education, and outreach activities largely have been successful<\/strong>, these efforts unfortunately have not deterred<\/strong> the continued proliferation of those manufacturing and marketing lucrative unapproved stem cell or related products.\u201d<\/p>\n<\/blockquote>\n It\u2019s like they are saying in one sentence the opposite things that their efforts have largely been successful but also unsuccessful.<\/p>\n The unsuccessful part (no deterrence of proliferation of unproven clinics and suppliers) seems more accurate.<\/p>\nThe AABB asks FDA about cord product misuse by bank customers<\/h2>\n
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FDA hasn\u2019t effectively acted on cord biologics misuse<\/h2>\n
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FDA has sent 28 warning letters in cell therapy space?<\/h2>\n
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Looking ahead, things still seem pretty bleak on unproven clinics<\/h2>\n
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