Stem Cells and Regenerative Medicine
Fuerst Ittleman David & Joseph is one of the country’s leading law firms for the stem cell and regenerative medicine industry. The firm has litigated extensively against the FDA regarding its jurisdiction to regulate procedures involving the autologous use of patients’ cells and tissue, and has lectured on dozens of occasions for industry trade groups across the United States and internationally.
Today, Fuerst Ittleman David & Joseph boasts a stem cell and regenerative medicine clientele composed of public and private companies, drug manufacturers, medical device manufacturers, doctors, hospitals and universities, and the firm’s clients are both domestic and international.
The firm has also consulted with foreign governments seeking to implement their own stem cell and regenerative medicine laws and regulations, and the firm has helped a number of its clients become licensed internationally to provide stem cell and regenerative medicine treatments abroad. The firm’s stem cell and regenerative medicine practice is at the core of the firm’s robust medical tourism practice.
The firm’s FDA practice group is deeply familiar with the manner by which the agency regulates stem cell and regenerative medicine products and services, and has advised clients regarding how the FDA regulates HCT/Ps derived from bone marrow, blood, adipose tissue (fat), placenta, and a number of other sources. In advising clients on these issues, the firm’s research begins at 21 CFR § 1271.10, where the FDA has created a three-part test which explains how the FDA will regulate human cells, tissues, or cellular or tissue-based products (“HCT/Ps”), both allogeneic (from a donor to a third party recipient) and autologous. In short, as it relates to autologous tissue and cells, the FDA has made it clear that unless the cells and tissue are a) “minimally manipulated” and b) used for a “homologous” purpose, the FDA will subject the medical procedure to the full scope of its biological drug regulations, including the submission of a Biologics License Application or an Investigational New Drug Application. The firm routinely advises its clients on the meaning of “minimal manipulation” and “homologous use,” and likewise helps clients understand whether their medical procedures are exempt from regulation by virtue of being a “same surgical procedure” as defined by 21 C.F.R. § 1271.15.
Pulling from its vast experience, the firm’s FDA practice group is able to assist its stem cell and regenerative medicine clients at every stage of the corporate lifespan. First, universities and other researchers seeking to develop new stem cell lines, medical procedures, medical devices and other regenerative medicine products and procedures can turn to the firm for advice regarding how, once the product or procedure under investigation has been fully developed, the FDA’s Part 1271 regulations will apply. Second, firms ready to interface with the FDA can count on the Fuerst Ittleman David & Joseph FDA practice group to aggressively pursue Investigational New Drug Applications, Biologics License Applications, and for medical devices, Premarket Approval Applications and 510(k) Notifications. Alternatively, if the client’s product or procedure is regulated solely by the FDA’s Part 1271 regulations, the client can count on the firm’s FDA practice group for advice regarding how to most effectively comply. Finally, for clients seeking to avail themselves of more favorable regulatory climates abroad, the firm can lend its advice regarding the long arm jurisdiction of the United States government, international tax and corporate issues, international licensing agreements, Customs and international shipping issues, and a host of others.
Our holistic approach to the stem cell and regenerative medicine industries is the prime example of how we provide comprehensive representation to clients operating in highly regulated industries.