As the COVID-19 pandemic continues, so have regulatory actions by the U.S. Food and Drug Administration (FDA) affecting the regenerative medicine industry.  This includes the issuance of agency demand letters also known as “warning” letters that are served on parties for alleged violations of federal law.  Historically, such actions were not rendered until an in-person inspection had taken place, giving a company time to prepare and comply.  However, based on the latest round of warning letters issued in 2020 and the last part of 2019, the FDA has transitioned to issuing these notices based solely on a review of a company’s website and other online materials which can often lead to a company being caught flat-footed and in violation.  This should be a reminder for businesses that offer unapproved stem cell products to immediately conduct a compliance review and determine if premarket review is required.

The FDA regulates the implantation, transplantation, infusion, or transfer of human cells and tissues into the body.  These cells and tissue products have been labeled by the FDA as HCT/Ps (i.e. human cells, tissues, and cellular and tissue-based products).  Usually, these types of products are regulated through the use of licensing applications that require premarket approval.  However, an exception exists for certain products from the review hurdle provided certain requirements are met.

But the guidance provided by the regulations around HCT/Ps have historically been viewed as unclear by the industry, and open to a wide range of interpretations.  This has led to many taking the position that their products fall under the “exception” (given it is the least costly regulatory option) than seeking premarket review which can be costly.  To crackdown on bad actors in the industry and to clear the air on its position, the FDA issued new guidance in November 2017.  In this guidance, the FDA announced a three-year window for businesses to come forward and seek guidance on whether a product requires premarket approval, rather than just make the cheaper assumption that the product falls under the “exception” from regulation.  But this discretionary enforcement period and free pass to the industry ends in less than five (5) months (in November 2020).

A careful review of the latest enforcement letters posted to its website, and a cursory review of company’s websites reveals that manufacturers and providers across the country continue to offer products requiring premarket approval but without having done so.  Many of these products are backed by unsubstantiated claims regarding the potential for these products to prevent, treat or cure various diseases or conditions.  As a result, the FDA continues to step up enforcement including based solely on online content.  As an illustration, on February 10, 2020, the FDA issued a warning letter to RejuvaYou based solely on a review of its website and related advertising.  In April 2020, similar warning letters were issued by the FDA to Dynamic Stem Cell Therapy and Stem Cell Center of New Jersey indicating premarket review was required.  As discussed above, these companies took the position that their products did not fall under the regulatory provisions of the FDA.

Entering the regenerative medicine market requires careful consideration as to the regulatory and legal landscape.  Manufacturers and individual providers need to be aware of the regulations and risks facing the industry.  Unless a product has FDA approval, businesses can face potential criminal and civil exposure.  In order to mitigate such exposure, businesses must first revisit their product designations in consultation with their attorneys to determine whether an exemption actually applies.

A great place to start is with the latest guidance.  Not only does this guidance set forth clarification, but it provides specific examples and a question and answer section explaining the FDA’s approach.  Another good source for insight is from legal filings from the U.S. Department of Justice on behalf of the FDA in the recent federal litigation involving U.S. Stem Cell.  U.S. Stem Cell challenged the regulatory authority of the FDA prompting the agency to a seek a permanent injunction (in which it obtained).  This decision provides valuable information on how the FDA views the current state of the industry.  An opinion should be sought from the FDA itself, even if informal, a step best taken with counsel by your side.  This can be accomplished through contacting the agency’s Tissue Reference Group.  By taking these steps, a business can better manage risk and expectations, and lessen the probability of running afoul of the FDA regulations and civil and criminal penalties.

 

If you have any questions regarding regenerative medicine legal issues, please do not hesitate to contact attorney Matthew M. Fischer (mfischer@zplaw.com).  Matthew is a partner in the Miami office of Zumpano Patricios, P.A.  Matthew specializes in health law related issues and is a former Assistant General Counsel at the FBI and Senior Attorney Advisor at the U.S. Department of Health and Human Services.