By: Matthew Fischer
Amid the growing focus on stem cell products by the Federal Food and Drug Administration (FDA), multiple states have proposed and passed some form of stem cell law or clinic regulation. While some center the regulation on informing prospective customers of the risks associated with these treatments others seek to protect the availability of these treatments in the form of a “right-to-try” law. Here are a few examples:
Effective January of this year, California implemented a new regulation in its Business and Professions Code aimed at clinics offering non-FDA approved stem cell treatments. The regulation requires a notice to be posted at the clinic entrance along with the requirement to provide a separate written notice to the patient prior to initiating treatment. However, this requirement does not apply if a licensed health care practitioner has obtained approval for an investigational new drug from the FDA.
Near the end of last year, Texas passed “Charlie’s Law” which expands on what many call “right-to-try” laws that protect a patient’s right to access investigational treatments if the patient has a chronic and terminal illness. The law also shields the patient’s physician in these cases. Specifically, the law prohibits the Texas Medical Board from revoking, failing to renew, suspending, or taking any action against a physician’s medical license based on the recommendation to use a stem cell treatment.
The Florida State Senate proposed a new bill in January requiring a physician or clinic owner to register the clinic with the Department of Health if the clinic met certain criteria. In March, the bill was withdrawn from consideration and died in the rules committee. In addition to registering, a clinic would have to undergo inspections and any physician practicing at an unregistered clinic may be subject to disciplinary action.
In short, states are increasing regulation and oversight of stem cell clinics, and more may be on the way. As the regenerative medicine industry continues to expand at a rapid pace, it is important to keep up to date with federal and state regulations.