Stem cell clinics have come under scrutiny from the Food and Drug Administration (FDA) for their treatment plans, which are not proven to be effective in preventing the medical conditions and diseases they claim to target. Despite growing concerns over these clinics, stem cell therapy continues to be marketed as a legitimate recourse for patients facing arthritis, cancer and other medical conditions. The FDA has generally agreed to practice enforcement discretion for 36 months in the context of stem cells. However, In response to these marketing tactics, the FDA has had to step in several times in the interest of patient health.

Why Does the FDA Care About Stem Cell Clinics?

The FDA has targeted stem cell clinics for different reasons, however their primary focus has been ensuring patient safety. In addition to being costly, most stem cell treatments have not been approved by the FDA. This means that they do not meet FDA expectations of safety and purity, and are potentially dangerous to patients. 

In a landmark case in 2015, a stem cell clinic in Florida conducted a procedure on three women to treat them for their macular degeneration. Instead of helping the women, the treatment left them with severe vision loss. This tragedy demonstrated some of the dangers posed by unapproved stem cell treatments, and their adverse effects on patient health. In addition to vision loss, stem cell therapy has also been linked to tumors and administrative site reactions. Due to the high risk involved in administering stem cell procedures, stem cell clinics have been closely monitored by the FDA.

FDA Oversight 

Stem cell clinics argue they are not subject to the FDA’s authority. However this is not always the case. The FDA has interpreted its authority to include situations where medical practitioner makes drug-like claims or sells drug-like products. This has generally been upheld by the courts. This means that the FDA does have jurisdiction over certain types of stem cell treatments. Stem cell clinics have argued against this ruling by saying that the FDA can only focus on factory use and marketing practices, not on efficacy of stem cell treatments. This has not shaken the FDA, which continues to exercise its jurisdiction over stem cell clinics. 

 In 2017, the FDA issued a warning letter to U.S. stem cell clinics about their marketing practices–claiming that their promotional materials violated good manufacturing practices. The clinics fought against this ruling, saying that they were not subject to FDA oversight because they did not produce drugs. Despite backlash, on June 3, 2019 a federal judge ruled that the FDA was entitled to permanent injunction against the stem cell clinics forcing them to stop manufacturing all stromal vascular fraction (SVF) products until they come into compliance with the law. Additionally, stem cell clinics offering fat-derivative treatments had to submit to annual inspections conducted by an independent expert for the next two years. After the inspections were conducted, clinics would have to destroy all stem cell products and would not be able to resume activity related to the injunction unless the FDA gave them permission. If a violation was found during FDA inspections, the clinic would be forced to correct the issue within 15 days or face daily penalties of $30,000. This ruling granted the FDA broad jurisdiction over stem cell clinics, and may influence future regulations.

The Future of Stem Cell Therapy

Although the FDA has primarily targeted fat-derivative stem cell treatments, this may change moving forward. The 2019 ruling may lead the FDA to target other unapproved stem cell treatments with litigation in the future. This means that stem cell clinics should remain cautious about the medical claims they are making about their treatment plans, and consult with a legal expert to ensure they remain FDA compliant.

If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.

I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the podcast on Google Play or on Soundcloud.

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The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.