By: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
Protecting patients is at the core of what we do at the U.S. Food and Drug Administration. Now the FDA is providing additional resources to help consumers understand the risks associated with unapproved stem cell, exosome, and other products marketed as regenerative medicine products. The agency is also facilitating the reporting of side effects that may occur after their use. The FDAs receipt of this information is important to developing a better understanding of the risks associated with these products and to helping the agency identify those clinics and manufacturers putting patients at risk.
Several times in recent years, the FDA warned consumers who have been treated with, or who are considering use of, unapproved stem cell, exosome, or other products marketed as regenerative medicine products, about their potential risk. These illegal products are often marketed by clinics under the umbrella term of regenerative medicine as being safe and effective for treatment of a wide range of diseases or conditions (e.g., Alzheimers disease and other neurologic disorders, orthopedic conditions), even though they have not been adequately studied in clinical trials. And more recently, some of these clinics have been marketing or distributing their unproven products to treat complications related to COVID-19 claims that are not based on adequate clinical data.
Consumers may also have been told by clinics and health care providers that because some of these products are made from their own cells, the FDA does not need to review or approve the treatment. That is simply not true. Further, claims that a clinics FDA registration or inspection equates to FDA approval or a form of FDA endorsement, or that listing a clinical study on clinicaltrials.gov means that it has been reviewed and allowed to proceed by the FDA, are also false.
It is of utmost concern that unapproved regenerative medicine products that have no proven clinical benefit and that may cause serious harm are marketed to patients. Using these products may lead to delays in getting a proper diagnosis and could also discourage patients suffering from serious illnesses from receiving safe and effective treatments that may be available. Whats also concerning is that we know that because these products are not FDA-approved, its very likely that adverse events are underreported by health care providers who treat patients with these products, and by patients who may have been harmed. We therefore strongly encourage patients and their family members to ask questions before receiving these types of products has the product been approved by the FDA? Has the product been approved for this use? Is the product being studied in a clinical trial that has been reviewed and allowed to proceed by the FDA? Am I being charged for an unapproved product?
We encourage patients and their health care providers to report to the FDA any potential adverse events and complaints related to the use of these products using the FDAs MedWatch Adverse Event Reporting program. Stem cell, exosome, or other products marketed as regenerative medicine products may have the potential to treat many medical conditions and diseases. But for almost all these products, it is not yet known whether each product has any benefit or if the product is safe to use. We want to make sure patients understand these potential risks in order to protect themselves from being treated with and paying for an unproven and illegally marketed products. The FDA has posted a webpage for consumers that provides information about products marketed as stem cells, exosomes or other regenerative medicine products, including the conditions for which they are approved, and which products are not approved at all. The webpage also provides information on how to submit information about adverse events to the FDAs MedWatch Adverse Event Reporting Program.
Unfortunately, weve found numerous instances of products being marketed to patients without FDA approval, as well as products being manufactured with significant deviations from current good tissue practice (CGTP) and/or current good manufacturing practice (CGMP) requirements. These violations have included deficient donor eligibility practices, and inadequate aseptic practices to prevent product contamination violations that have the potential to place patients at risk. Patients have been harmed after being administered some of these violative products.
We encourage consumers who are considering treatment with regenerative medicine products to work with their health care providers to learn about the treatment being offered, and to visit our webpage. It is important to ask questions and understand the potential risks of treatment with unapproved products. The FDA will continue to work with the manufacturers of these products to support their development. But we will also continue to take appropriate action against those who put patients in harms way.
Additional Resources:
07/22/2020
Original post:
Potential Risks of Treatment with Unapproved Regenerative Medicine Products - FDA.gov
- Yes, But. The Annotated Atlantic. - November 7th, 2009 [November 7th, 2009]
- Health Insurance Benefit Costs by Region - November 8th, 2009 [November 8th, 2009]
- For an Operator, Please Press... - November 8th, 2009 [November 8th, 2009]
- Pollyanna With a Pen: Maine Governor Signs 18 New Health Care Bills into Law - November 8th, 2009 [November 8th, 2009]
- AMA Sounds the Alarm, Medicare Making Yet Another Attempt to Cut Reimbursement - November 8th, 2009 [November 8th, 2009]
- Mass Governor Asks Blue Cross to Keep Higher Employer Contribution - November 8th, 2009 [November 8th, 2009]
- Lifespan and Care New England Plan Monopoly (Again) - November 8th, 2009 [November 8th, 2009]
- Dirigo Health: Con Artists, Liars, and Thieves? - November 8th, 2009 [November 8th, 2009]
- New Orleans: Health Challenges - November 8th, 2009 [November 8th, 2009]
- August a Flurry of Activity - November 8th, 2009 [November 8th, 2009]
- Maine's Dirigo Health Savings One-Third of Original Estimate - November 8th, 2009 [November 8th, 2009]
- “Methodolatry”: My new favorite term for one of the shortcomings of evidence-based medicine - November 8th, 2009 [November 8th, 2009]
- Suzanne Somers’ Knockout: Dangerous misinformation about cancer (part 1) - November 8th, 2009 [November 8th, 2009]
- A science-based blog about GMO - November 8th, 2009 [November 8th, 2009]
- A Not-So-Split Decision - November 8th, 2009 [November 8th, 2009]
- Military Medicine in Iraq - November 8th, 2009 [November 8th, 2009]
- The effective wordsmithing of Amy Wallace - November 8th, 2009 [November 8th, 2009]
- A Science Lesson from a Homeopath and Behavioral Optometrist - November 8th, 2009 [November 8th, 2009]
- Join CFI in opposing funding mandates for quackery in health care reform - November 8th, 2009 [November 8th, 2009]
- Mainstreaming Science-Based Medicine: A Novel Approach - November 8th, 2009 [November 8th, 2009]
- Those who live in glass houses… - November 8th, 2009 [November 8th, 2009]
- J.B. Handley of the anti-vaccine group Generation Rescue: Misogynistic attacks on journalists who champion science - November 8th, 2009 [November 8th, 2009]
- When homeopaths attack medicine and physics - November 8th, 2009 [November 8th, 2009]
- The cancer screening kerfuffle erupts again: “Rethinking” screening for breast and prostate cancer - November 8th, 2009 [November 8th, 2009]
- All Medicines Are Poison! - November 8th, 2009 [November 8th, 2009]
- When Loud Wins: Will Your Tax Dollars Pay For Prayer? - November 8th, 2009 [November 8th, 2009]
- It’s All in Your Head - November 8th, 2009 [November 8th, 2009]
- The Skeptical O.B. joins the Science-Based Medicine crew - November 8th, 2009 [November 8th, 2009]
- The Tragic Death Toll of Homebirth - November 8th, 2009 [November 8th, 2009]
- What’s the right C-section rate? Higher than you think. - November 8th, 2009 [November 8th, 2009]
- Recombinant Human Antithrombin – Milking Nanny Goats for Big Bucks - December 13th, 2009 [December 13th, 2009]
- Does C-section increase the rate of neonatal death? - December 13th, 2009 [December 13th, 2009]
- Man in Coma 23 Years – Is He Really Conscious? - December 13th, 2009 [December 13th, 2009]
- Why Universal Hepatitis B Vaccination Isn’t Quite Universal - December 13th, 2009 [December 13th, 2009]
- Ontario naturopathic prescribing proposal is bad medicine - December 13th, 2009 [December 13th, 2009]
- Naturopaths and the anti-vaccine movement: Hijacking the law in service of pseudoscience - December 13th, 2009 [December 13th, 2009]
- The Institute for Science in Medicine enters the health care reform fray - December 13th, 2009 [December 13th, 2009]
- Neti pots – Ancient Ayurvedic Treatment Validated by Scientific Evidence - December 13th, 2009 [December 13th, 2009]
- Early Intervention for Autism - December 13th, 2009 [December 13th, 2009]
- A temporary reprieve from legislative madness - December 13th, 2009 [December 13th, 2009]
- A critique of the leading study of American homebirth - December 13th, 2009 [December 13th, 2009]
- Lose those holiday pounds - December 13th, 2009 [December 13th, 2009]
- Endocrine disruptors—the one true cause? - December 13th, 2009 [December 13th, 2009]
- Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome - December 13th, 2009 [December 13th, 2009]
- Evidence in Medicine: Experimental Studies - December 13th, 2009 [December 13th, 2009]
- Midwives and the assault on scientific evidence - December 13th, 2009 [December 13th, 2009]
- The Mammogram Post-Mortem - December 13th, 2009 [December 13th, 2009]
- An Influenza Recap: The End of the Second Wave - December 13th, 2009 [December 13th, 2009]
- The End of Chiropractic - December 13th, 2009 [December 13th, 2009]
- Cell phones and cancer again, or: Oh, no! My cell phone’s going to give me cancer! (revisited) - December 20th, 2009 [December 20th, 2009]
- Another wrinkle to the USPSTF mammogram guidelines kerfuffle: What about African-American women? - December 20th, 2009 [December 20th, 2009]
- Acupuncture, the P-Value Fallacy, and Honesty - December 20th, 2009 [December 20th, 2009]
- The One True Cause of All Disease - December 20th, 2009 [December 20th, 2009]
- Communicating with the Locked-In - December 20th, 2009 [December 20th, 2009]
- Are the benefits of breastfeeding oversold? - December 20th, 2009 [December 20th, 2009]
- Measles - December 20th, 2009 [December 20th, 2009]
- Radiation from medical imaging and cancer risk - December 21st, 2009 [December 21st, 2009]
- Multiple Sclerosis and Irrational Exuberance - December 21st, 2009 [December 21st, 2009]
- Medical Fun with Christmas Carols - December 22nd, 2009 [December 22nd, 2009]
- Lithium for ALS – Angioplasty for MS - December 23rd, 2009 [December 23rd, 2009]
- “Toxins”: the new evil humours - December 24th, 2009 [December 24th, 2009]
- 2009’s Top 5 Threats To Science In Medicine - December 24th, 2009 [December 24th, 2009]
- Buteyko Breathing Technique – Nothing to Hyperventilate About - December 26th, 2009 [December 26th, 2009]
- The Graston Technique – Inducing Microtrauma with Instruments - December 29th, 2009 [December 29th, 2009]
- The “pharma shill” gambit - December 29th, 2009 [December 29th, 2009]
- Ginkgo biloba – No Effect - December 30th, 2009 [December 30th, 2009]
- Oppose “Big Floss”; practice alternative dentistry - January 1st, 2010 [January 1st, 2010]
- Causation and Hill’s Criteria - January 3rd, 2010 [January 3rd, 2010]
- The life cycle of translational research - January 10th, 2010 [January 10th, 2010]
- The anti-vaccine movement strikes back against Dr. Paul Offit - January 10th, 2010 [January 10th, 2010]
- Osteoporosis Drugs: Good Medicine or Big Pharma Scam? - January 10th, 2010 [January 10th, 2010]
- Acupuncture for Hot Flashes - January 10th, 2010 [January 10th, 2010]
- The case for neonatal circumcision - January 10th, 2010 [January 10th, 2010]
- A victory for science-based medicine - January 10th, 2010 [January 10th, 2010]
- James Ray and testosterone replacement therapy (TRT) - January 10th, 2010 [January 10th, 2010]
- The Water Cure: Another Example of Self Deception and the “Lone Genius” - January 12th, 2010 [January 12th, 2010]
- Be careful what you wish for, Dr. Dossey, you just might get it - January 13th, 2010 [January 13th, 2010]
- You. You. Who are you calling a You You? - January 15th, 2010 [January 15th, 2010]
- The War on Salt - January 16th, 2010 [January 16th, 2010]
- Is breech vaginal delivery safe? - January 16th, 2010 [January 16th, 2010]