The U.S. Food and Drug Administration (“FDA”) regulates the implantation, transplantation, infusion, or transfer of human cells and tissues into the body (i.e., regenerative medicine products). Relatively few treatments have been approved by the FDA, but many are in clinical development, and the number of approved products is expected to grow over the next several years. Amid the growing focus on regenerative medicine by the FDA, multiple states have enacted some form of regulation. While some focus the regulation on informing prospective patients of the risks associated with treatments (e.g., California and Washington), others seek to protect the availability of treatments in the form of “right-to-try” laws (e.g., Texas). Florida has introduced multiple bills taking similar approaches, but none have yet to be enacted. This timeline will cover Florida’s efforts and act as a reminder to industry providers and other stakeholders to remain attentive for potential local regulation.
In January 2018, House Bill 1185 (“HB 1185”) was introduced and focused on registration and the inspection of clinics offering regenerative medicine products. Specifically, HB 1185 required clinic owners to register with the Florida Department of Health (“DOH”) and additionally, designate a physician responsible for complying with the new requirements. Moreover, HB 1185 required clinics to undergo annual inspections conducted by the DOH. Shortly after its filing, HB 1185 died in the Appropriations Committee.
In contrast, House Bill 65 (“HB 65”) took a more stringent approach and required “investigational stem cell” treatments to be administered directly by a licensed and certified physician to a patient that has been diagnosed with a severe chronic disease or terminal illness. Notably, HB 65 also limited the location of providing such treatment to specific locations with oversight by an “institutional review board.” HB 65 was initially filed in November 2018 and died in the Health Quality Subcommittee in May 2019.
The most recent attempt was House Bill 313 (“HB 313”) introduced in October 2019. HB 313 called for voluntary registration of regenerative medicine providers (who upon registration certify that they agree to follow good manufacturing practices) and required the DOH to maintain an online registry of such providers. HB 313 died in the Health and Human Services Committee in March 2020.
Regulatory oversight over this rapidly evolving field has been historically viewed as unclear by the industry, and open to a wide range of interpretations. In the face of limited guidance and action from the FDA, and with strong and well-organized constituencies at the local levels active on the issue, states such as Florida will continue to be drawn into the regenerative medicine legislative arena. Thus, it is essential for all stakeholders in the industry to continue to monitor any legislative action to ensure compliance and remain well-positioned to adapt to emerging policies.