The U.S. Food and Drug Administration (FDA) is a federal agency with incredibly broad jurisdiction. For the past 100 years, the FDA’s jurisdiction has frequently expanded to the point where it now regulates nearly one-fifth of the U.S. economy, and directly impacts the lives of the American people every day. In the past 20 years, the FDA has expanded its jurisdiction into the regulation of the regenerative medicine industry and, specifically, medical treatment involving the use of a patient’s autologous cells and tissues.
In this article, we discuss recent announcements from the FDA regarding its intention to regulate doctors’ use of adipose-derived cells and tissues to treat their patients’ medical conditions. But first some background: In the code of Federal Regulations, at 21 CFR § 1271.10, the FDA has created a three-part test which explains how it 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 clear that unless the cells and tissue are a) “minimally manipulated” and b) used for a “homologous” purpose, it will subject the medical procedure to the full scope of the agency’s biological drug regulations, including a requirement for the submission of a Biologics License Application (BLA) or an Investigational New Drug Application (IND).
Defining the Terms
Both by regulation and less formal public pronouncements, the FDA has defined the terms “minimal manipulation” and “homologous use” in such a way as to encompass a wide variety of medical procedures involving the use of a patient’s own cells and tissues. On the one hand, the FDA defines “manual manipulation” as “processing that does not alter the relevant biological characteristics” of the cells or tissue. On the other hand, it defines “homologous use” as “the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.” In practice, the FDA interprets both definitions in the narrowest way possible.
These regulations appear to create an exception to the FDA’s jurisdiction if “you are an establishment that removes HCT/Ps from an individual and implants such HCT/Ps into the same individual during the same surgical procedure.” (21 CFR § 1271.15(b)). While the plain language of that regulation alone might appear to create a safe harbor for most autologous procedures so long as the procedure only lasts a brief duration, the FDA has made clear that time is not relevant to the analysis of whether a procedure qualifies for the safe harbor. And, as we explain in more detail below, the FDA’s interpretation of this exception is far narrower than its plain language might otherwise reveal.
Putting Terms Into Practice
In late 2014, the FDA issued three draft guidance documents explaining its own jurisdiction to regulate medical procedures involving, inter alia, adipose-derived tissue and cells, as well as the expectations it has of regulated entities. The first of the three guidance documents, issued in October 2014, outlined the agency’s position on the scope of the “same surgical procedure” exception discussed above. The second, issued in December 2014, outlined the FDA’s position regarding the meaning of minimal manipulation, as well as the types of procedures that fit within its definition of that term. The final of the three documents, also issued in December 2014, set forth its position regarding HCT/Ps derived from adipose tissue.
In order to explain how the FDA regulates the use of autologous fat in the treatment of patients, consider the following hypothetical:
Dr. Jones is a cosmetic surgeon. He claims in a variety of advertisements that by using patients’ own fat, he can cure a wide variety of his patients’ ailments and make them look younger too. The indications he treats with autologous fat and the manner by which he processes his patients’ fat will determine whether—and if so, how—the FDA regulates his practice.
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