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 "untitled" letters. Typically, untitled letters are initial FDA correspondence to an individual or company citing violations that the FDA deems to be less severe and not of regulatory significance warranting a "warning" letter (that threatens immediate agency action). According to the FDA’s website, not all untitled letters are posted online and only posted if certain objectives are fulfilled such as to “deter future violations and allow similarly situated regulated entities to determine what activities and practices FDA finds violative and use the information to increase compliance with the law.” Based on the latest round of letters issued in 2020 and the latter part of 2019, the FDA has focused on issuing letters to manufacturers of various stem cell products. 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 which has been amended in July 2020. In this guidance, the FDA announced a multi-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.
After a careful review of the latest enforcement letters posted to its website, the FDA continues to step up enforcement including reviews based solely on online content. As an illustration, on February 10, 2020, the FDA issued an untitled letter to RejuvaYou based solely on a review of its website and related advertising. In April 2020, similar 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 (matt@fischerlawpa.com).
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