Following the courts decision in US Stem Cell Clinic, CBER Director Peter Marks, M.D., stated in an FDA Voices blog post that the agency will continue cracking down on unapproved products marketed as regenerative medicine therapies, citing how the US Stem Cell decision is a victory for public health and an endorsement of the FDAs work to stop stem cell clinics that place patients at risk by marketing products that violate the law. Dr. Marks also referred to a second injunction case, United States v. Cell Surgical Network et al., which is currently being litigated in the U.S. District Court for the Central District of California, and a third enforcement action pursued by the FDA involving the seizure of vials of Vaccinia Virus Vaccine, Live, which was resolved in March 2018.
Since 2015, FDA has been documenting violations of current Good Manufacturing Practice (cGMP) requirements for tissue products by US Stem Cell Clinic. The agency issued aWarning Letterto the clinic in August 2017, which weanalyzed here. The clinic claimed that FDAs cGMP regulations were not applicable because the treatment falls under FDAs same surgical procedure and 361 HCT/P exceptions to regulation under the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA). In June 2019, a Florida district court ruled in favor of FDA, and enjoined the clinic from offering its stem cell therapy to patients.
As we summarized (here), the district courtfoundthat the population of stromal and vascular cells in US Stem Cell Clinics therapy, known as stromal-vascular fraction (SVF), requires FDA approval of a New Drug Application (NDA) or a Biologics License Application (BLA) before it can be commercially marketed. The court also found that the therapy was adulterated and misbranded because of the clinics manufacturing procedures and that its promotion violated statutory requirements.
On appeal with the Eleventh Circuit, US Stem Cell Clinic again argued it is exempt from regulation under the FDCA because the procedure falls into the same surgical procedure exception at 21 C.F.R. 1271.15(b). This provision states that FDAs regulation does not apply if you are an establishment that removes HCT/Ps from an individual and implants such HCT/Ps into the same individual during the same surgical procedure. Arguing before the District Court, FDA had successfullyassertedthat the SVF implanted into the clinics patients does not constitute such HCT/P removed from the patient due to the processing steps applied to the SVF in this case, meaning US Stem Cell Clinic was not covered by this exception.
In prefacing its analysis, the Eleventh Circuit notably explained that it was not merely offering judicial deference to FDA, saying it was giving the agencys view no special weight. The court said that although [t]here was a time when a court faced with a regulation that seemed impenetrable on first read might simply wave the ambiguity flag and defer to the agencys interpretation, this is the case [n]o longer. Rather, the court carefully consider[ed] the text, structure, history, and purpose of [the] regulation, and resolved the apparent ambiguity in FDAs favor.
First, the court considered the clinics argument that cells or tissues can be HCT/Ps only if they are intended for implantation into a patient, and it is the SVF and not the adipose tissue that is intended for implantation. The court rejected this defense, explaining that because adipose tissue contains the SVF, and because HCT/Ps are articles containing or consisting of human cells or tissues that are intended for implantation into a patient, both the adipose tissue and the SVF are HCT/Ps subject to regulation.
Second, US Stem Cell Clinic argued that an HCT/P re-implanted into a patient meets the regulatory definition of such HCT/P if it is like or similar to the HCT/P removed from the patient. The Eleventh Circuit disagreed. Instead, the court adopted FDAs interpretation that such HCT/P refers to the antecedent HCT/P removed from the patient in its original form. The Eleventh Circuit agreed with FDA and the District Court that the SVF procedure does not fall within the same surgical procedure exception because the biological material implanted into the patient is not the same as that removed. The court cited a history of FDA treating such HCT/Ps as meaning HCT/Ps in their original form that have not been subjected to significant processing.
The clinic also argued on appeal that it is exempt from regulation under the FDCA and PHSA because the procedure falls into the 361 HCT/P exception, whereby an HCT/P meeting four criteria (set forth in 21 C.F.R. 1271.10(a)) is deemed a 361 HCT/P, meaning that it is regulated solely under Section 361 of the Public Health Service Act (PHSA) and its implementing regulations in 21 C.F.R. Part 1271. Being deemed a 361 HCT/P subjects a therapy to a lighter regulatory burden. However, the Eleventh Circuit ruled that the 361 HCT/P exception does not apply because the HCT/P in this case is not intended for homologous use only.
Homologous use is the repair, reconstruction, replacement, or supplementation of a recipients cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor. 21 C.F.R. 1271.3(c). US Stem Cell Clinic argued that SVF meets the homologous use criterion of a 361 HCT/P because SVF was intended to perform the same basic regenerative function both before and after the procedure. However, the District Court determined that the Clinic intended that the SVF treat a litany of illnesses in the recipient, which is not the same basic function that the SVF performed prior to the procedure.
The Eleventh Circuit agreed with the District Court that the clinic intends the stem cells to perform functions after the procedure that are beyond the basic functions the stem cells performed prior to the procedure. The court said that promotion of an HCT/P for an unproven therapeutic use, such as curing cancer, would be a nonhomologous use, and thus the 361 HCT/P exception does not apply in this case. In making this determination, the court said it relied upon the labeling, advertising, and other indications of the manufacturers objective intent. Because the defendants had marketed their SVF therapy to treat an array of diseases, the court found the clinic could not argue the pre-procedure SVF cells were intended to have performed the same function as the re-implanted SVF cells.
In issuing its opinion, the court permanently enjoined US Stem Cell Clinic from offering its adipose stem cell therapy unless and until several conditions were met, including FDA approval of a new drug application or biologics license application for the SVF solution.
In 2017, FDA published a new regenerative medicine policyframeworkconsisting of four guidance documents, which provided for a grace period of risk-based enforcement discretion for certain HCT/Ps, which ended on May 31, 2021. This grace period was meant to give certain manufacturers time to assess whether they need to file an IND or marketing application with FDA, or whether they met the four regulatory criteria for continuing to market their products solely under the authority of section 361 of the PHSA, which does not require pre-market review and approval.
Following up on the governments victory in this legal battle, CBER Director Peter Marks, M.D., published a blog on June 3 warning that FDA will be cracking down on unapproved products marketed as regenerative medicine therapies, citing how the Eleventh Circuit affirmed the lower courts judgment in US Stem Cell as cause for the renewed admonition. Marks wrote that the US Stem Cell decision is a victory for public health and an endorsement of the FDAs work to stop stem cell clinics that place patients at risk by marketing products that violate the law.
More recently, on July 9, CBER added a Q&A page on its website about the end of the HCT/P enforcement discretion period, drawing a clear line in the sand to convey that FDA is serious about the end of enforcement discretion period. Notably, the Q&A page directs physicians not to administer an HCT/P that does not qualify for 361 HCT/P status, until that HCT/P has a BLA, unless that physician is studying the HCT/P as a clinical investigator in a clinical trial under an IND. It also appears to say that there is no grace period for products that were introduced into interstate commerce before May 31, 2021 and are still on the market.
This was the not the first time that CBER has warned of impending enforcement of its regenerative medicine policy framework; in an FDA Voices blog post on April 21, Marks had written that the agency will not again extend the grace period for HCT/P companies to come into compliance with its regenerative medicine policy framework. In both that article and the June 3 publication, Marks emphasized that FDA has taken and will continue to take action regarding unlawfully marketed HCT/Ps. Most recently Marks wrote that, since December 2018, the FDA has issued 400 letters to manufacturers and health care providers who may be offering violative stem cell or related products. In addition, since 2017, FDA has issued 14 Warning Letters and 24 Untitled Letters involving violative HCT/Ps, Marks wrote.
We recently analyzed (online here) the significance that these warnings carry for companies in the regenerative medicine space, and outlined the potential risks of noncompliance. These risks go well beyond FDA enforcement, and include the possibility of FTC action, False Claims Act liability, product liability claims, and susceptibility to private lawsuits.
[View source.]
See original here:
- SUM Hospital conducts Odishas first stem cell transplantation - The Times of India - April 24th, 2024
- Cancer treatment: What is stem cell therapy, and how does it work? - Moneycontrol - April 24th, 2024
- The murky, unregulated world of anti-ageing stem cell therapy - The Telegraph - April 24th, 2024
- Drug Prototype Promising in Treatment of Pulmonary Disease - Medscape - April 20th, 2024
- Man Paralyzed In Surfing Accident Regains Ability to Walk After Stem Cell Treatment - The Inertia - April 20th, 2024
- Medical breakthrough: 8-year-old boy first in New York to receive FDA-approved gene therapy for rare inherited blood disorder - WABC-TV - April 20th, 2024
- Stem Cell Treatment Helped A Man Who Was Paralyzed From The Neck Down To Stand On His Own - Bored Panda - April 20th, 2024
- UM, CUHK jointly hold symposium on stem cells and regenerative medicine - gcs.gov.mo - April 20th, 2024
- Paralysed patient now able to walk as stem cell therapy shows promising results - WION - April 15th, 2024
- Andrew Steele Sees Aging as the Root of Disease - Worth - Worth Magazine - April 15th, 2024
- The astonishing effect of stem cell implants - as groundbreaking treatment 'transforms' life for those with brain damage ... - Daily Mail - April 15th, 2024
- Consumer Alert on Regenerative Medicine Products Including Stem Cells - FDA.gov - April 13th, 2024
- This Startup Wants To Be OpenAI Of Stem Cell Therapy, Targets $250B Market - Forbes - April 13th, 2024
- Brain-cell transplants are the newest experimental epilepsy treatment - MIT Technology Review - April 3rd, 2024
- Global Regenerative Medicine Market to Touch Valuation of USD 472.95 Billion by 2032, at 25.86% CAGR: Astute ... - Yahoo Finance - April 1st, 2024
- Explosive Growth Projected for Stem Cell Market, Expected to Surpass $37 Billion by 2030 As Revealed In New... - WhaTech - April 1st, 2024
- Integrating New Therapies With Autologous Stem Cell Transplant in Myeloma - Targeted Oncology - April 1st, 2024
- New tool provides researchers with improved understanding of stem cell aging in the brain - Medical Xpress - March 30th, 2024
- The ISSCR announces 2024 election results - EurekAlert - March 28th, 2024
- Exosomes and Stem Cells Are the Future of Anti-Aging - NewBeauty Magazine - March 28th, 2024
- Charles River Extends Gene Therapy Alliance with NUS Medicine - Contract Pharma - March 22nd, 2024
- Exciting opportunities in stem cell technology and regenerative biology in Indian healthcare industry - Express Healthcare - March 22nd, 2024
- Charles River Announces Extension of Gene Therapy Manufacturing Alliance with NUS Yong Loo Lin School of Medicine - Yahoo Finance - March 22nd, 2024
- Opinion: The revolutionary sickle cell therapies - MSN - March 22nd, 2024
- 10 Years of Kansas Regenerative Medicine Center - KSAL - March 22nd, 2024
- BioCardia and StemCardia Announce Biotherapeutic Delivery Partnership - Diagnostic and Interventional Cardiology - March 17th, 2024
- Cynata Therapeutics' breakthrough in regenerative medicine - Finance News Network - March 17th, 2024
- New Positive Data Presented on Briquilimab Conditioning in Patients with Fanconi Anemia - GlobeNewswire - March 17th, 2024
- Novel 3D stem cell therapy to treat critical limb ischaemia - Drug Target Review - March 15th, 2024
- Breaking Boundaries: Pharmicell's Bold Vision for Healthcare Transformation and Monumental Growth - The Worldfolio - March 15th, 2024
- CuSTOM Organoid Research Evolving From Tool to Treatment - Research Horizons - Research Horizons - March 15th, 2024
- BioCardia and StemCardia Announce Partnership to Deliver Cell-Gene Therapy for Remuscularization of Heart - Cath Lab Digest - March 15th, 2024
- Calidi Biotherapeutics and City of Hope Announce Funding from the California Institute for Regenerative Medicine ... - Business Wire - March 13th, 2024
- Iron restriction keeps blood stem cells young, researchers find - Phys.org - March 13th, 2024
- Vitamin A could have a key role in both stem cell biology and wound healing: Study - Medical Dialogues - March 9th, 2024
- Trends in Stem Cell Transplantation Refusal for Myeloma Treatment - Targeted Oncology - March 7th, 2024
- Stem Cell Therapy Market (CAGR) of 31.1%, Future of Market Size Emerging Technologies and their Impact on ... - Taiwan News - March 7th, 2024
- This Swedish startup wants to reduce the cost, and controversy, around stem cell production - TechCrunch - March 6th, 2024
- Advancing stem cell therapy: The regulatory process to get to clinical trials - The Economic Times - March 6th, 2024
- Transitioning from traditional surgical methods to the innovative use of stem cells - pharmaphorum - March 6th, 2024
- 'Mini organs' are grown from human stem cells taken during the late stages of pregnancy for the first time - m - Daily Mail - March 6th, 2024
- Stem cell transplant cures man of HIV and leukemia, one of five to achieve full remission - Fox 28 - March 3rd, 2024
- Stem Cell Therapy Market to Boost USD 137.5 Billion by 2034 and Projected to grow at 32.10% CAGR with increasing ... - Yahoo Finance - March 1st, 2024
- Studies expand use of stem cell therapies - WPLG Local 10 - March 1st, 2024
- Innovative therapy targets and destroys leukemia stem cells - News-Medical.Net - February 27th, 2024
- Unlocking the Potential of Stem Cells: The Medical Revolution of the Century - EIN News - February 27th, 2024
- Pelage Pharmaceuticals Announces $16.75M Series A Financing led by GV to Revolutionize Regenerative Medicine ... - Yahoo Finance - February 27th, 2024
- Say Her Name - Henrietta Lacks, The Real Mother Of Stem - Her Campus - February 27th, 2024
- California Man Free of HIV And Cancer in Astonishing Medical Recovery - ScienceAlert - February 25th, 2024
- $93 million for research into improved health for children, young people and the aged, medical devices, mental health ... - Department of Health - February 25th, 2024
- Stem Cells in Regenerative Medicine - PMC - National Center for ... - February 24th, 2024
- The Promise and Reality of Stem Cell Therapy: What You Need to Know - Corporate Wellness Magazine - February 22nd, 2024
- Stem Cell Therapy: A Beacon of Hope for Patients with Untreatable Conditions - Corporate Wellness Magazine - February 22nd, 2024
- Leading Experts in Stem Cell Therapy: A Global Overview - Corporate Wellness Magazine - February 22nd, 2024
- Can Stem Cells Help Reverse the Effects of Aging? - Corporate Wellness Magazine - February 22nd, 2024
- Stem Cell Therapy for Cancer: Hope on the Horizon? - Corporate Wellness Magazine - February 22nd, 2024
- Stem Cells and Autism: A Closer Look at Innovative Treatments - Corporate Wellness Magazine - February 22nd, 2024
- Regrowth and Restoration: The Science Behind Stem Cell Therapy for Hair - Corporate Wellness Magazine - February 22nd, 2024
- Brain Recovery: The Role of Stem Cells in Stroke and Cerebral Palsy Treatments - Corporate Wellness Magazine - February 22nd, 2024
- Turning Back the Clock: The Science of Stem Cells in Anti-Aging - Corporate Wellness Magazine - February 22nd, 2024
- Insights into cellular therapies for cancer treatment - Drug Target Review - February 22nd, 2024
- The Role of Stem Cells in Rheumatoid Arthritis Recovery - Corporate Wellness Magazine - February 22nd, 2024
- Dr Ernesto Romeros vision transforms immunotherapy regenerative medicine into a global leader in stem cell treatment - Khaleej Times - February 22nd, 2024
- World-Renowned Doctors Leading the Way in Stem Cell Research and Treatment - Medical Tourism Magazine - February 20th, 2024
- Choosing the Best: A Guide to America's Premier Stem Cell Therapy Providers - Medical Tourism Magazine - February 20th, 2024
- Navigating Through the Possibilities of Stem Cell Treatment for Eye Disorders - Medical Tourism Magazine - February 20th, 2024
- Global Leaders in Stem Cell Therapy: Where Excellence Meets Innovation - Medical Tourism Magazine - February 20th, 2024
- Excellence in Stem Cell Treatment: How the US is Pioneering Global Healthcare Solutions - Medical Tourism Magazine - February 20th, 2024
- Clarifying Memory Loss Treatments: The Role of Stem Cells - Medical Tourism Magazine - February 20th, 2024
- Battling Inflammation: Stem Cell Therapy for Rheumatoid Arthritis - Medical Tourism Magazine - February 20th, 2024
- Digestive Health and Stem Cells: Treating Ulcerative Colitis and Crohn's Disease - Medical Tourism Magazine - February 20th, 2024
- Top Stem Cell Clinics in the USA: Pioneering Treatments for Chronic Conditions - Medical Tourism Magazine - February 20th, 2024
- Stem Cells and Autism: Understanding the Potential for Innovative Treatments - Medical Tourism Magazine - February 20th, 2024
- Stopping the awakening of sleeping Acute Myeloid Leukaemia stem cells to prevent disease relapse - University of Birmingham - February 20th, 2024
- City of Hope Achieves Ground Breaking Treatment for Blood Cancer and HIV - Medriva - February 18th, 2024
- Regenerative Medicine Market Size to Worth USD 95 Billion by 2032 - InvestorsObserver - February 18th, 2024
- North America Organoids Market Projected to Reach US$ 5.35 Billion by 2030, Riding on a CAGR of 21.5% - GlobeNewswire - February 18th, 2024
- Chinese team tests lung treatment that may be first to reverse COPD damage - South China Morning Post - February 15th, 2024
- Why leukemic stem cells not harmed by chemotherapy begin to grow and produce AML cells after treatment - Medical Xpress - February 15th, 2024
- Regenerative Medicine Market is Expected to Reach $49.0 Billion | MarketsandMarkets - Yahoo Finance - February 15th, 2024
Recent Comments