On October 29, the Food and Drug Administration (FDA) released a draft guidance titled “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products” (HCT/Ps). This is the fourth draft guidance issued in the past year concerning the regulation of HCT/Ps. According to FDA’s general approach, if certain criteria are met, HCT/Ps are regulated solely under section 361 of the Public Health Service Act (providing for the control of transmissible diseases) and are not regulated under the premarket review or other provisions of the Federal Food, Drug and Cosmetic Act (FDCA). The newest draft guidance addresses one of those criteria: whether the HCT/P is intended for a “homologous use”; that is, whether it “performs the same basic function or functions in the recipient as in the donor.”1
On the same day, FDA reopened the comment periods for the three other recent draft guidances related to HCT/Ps. The other Draft Guidances address (1) whether an HCT/P has been “minimally manipulated,”2 (2) an exception for establishments that “remove . . . and implant . . . HCT/Ps into the same individual during the same procedure,”3 and (3) specific considerations for HCT/Ps derived from adipose tissue.4 Notably, FDA also announced a public hearing on April 13, 2016 to discuss all four draft guidances.
The draft guidances reflect FDA’s effort to narrow the category of products that may be marketed as HCT/Ps, thereby forcing more products to comply with the premarket requirements applicable to drugs, devices, and/or biological products. Specifically:
- In the December 2014 draft guidance on minimal manipulation, FDA announced a new framework in which individual tissue categories are assigned a “main function” to determine whether HCT/Ps in those categories will be deemed derived from “structural” or “non-structural” tissue. That new framework cast doubt on longstanding assumptions regarding the status of many established HCT/Ps.
- In the December 2014 draft guidance regarding adipose tissue products, FDA likewise took a narrow view of the “basic function” of those products. FDA also made clear that it considers all connective tissue, including adipose tissue, to be “structural” tissue.
- In the December 2014 draft guidance regarding the same surgical procedure exception, FDA stated that it considered the exception to be “narrow” and announced three new criteria to meet to qualify for the exception.
- The draft guidance on homologous use provides several examples of uses that FDA does not consider to be homologous (despite prior statements to the contrary), which will further limit the scope of products regulated solely as HCT/Ps.
Even before the draft guidance, FDA’s new approach had prompted stakeholders to not only recommend that FDA reconsider its position but also urge the agency to hold a public workshop. In setting a public hearing to gather input on the four draft guidances, FDA appears to have responded to those requests. Interested parties—including HCT/P manufacturers, tissue establishments and health care professionals—should pay close attention to the upcoming public hearing, which may reveal the extent to which FDA intends to limit the types of products that may properly be manufactured and sold as HCT/Ps.