LS&HC Horizons 2023 - Flipbook - Page 9
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Precision and Regenerative Medicine
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FDA oversight of HCT/Ps: advertisers beware
Since May 31, 2021, when FDA formally
ended its suspension of enforcement action
against human cells, tissues, and cellular
and tissue-based products (HCT/Ps), FDA
has increased its HCT/P oversight. It has
issued over 13 warning letters and Center for
Biologics Evaluation and Research (CBER)
leadership has publicized its intent to increase
enforcement. The warning letters primarily
focused on advertising claims that were overly
broad. Such claims create the risk that
HCT/Ps otherwise eligible to be marketed
without FDA approval and regulated solely
under the authority of Section 361 of the Public
Health Service Act, as “361 HCT/Ps”, will lose
that status and be subject to the requirements
of FDA pre-market review and approval.
primary function, unless they are autologous
(transplantation from the patient back into the
same patient), transplanted to a near relative,
or for reproduction. Manufacturers should
consider FDA’s 2020 Guidance on minimal
manipulation and homologous use to assess
the appropriateness of their advertising claims.
Among other things, manufacturers should
avoid broad claims that their HCT/P product
treats particular diseases or conditions.
As FDA focuses on HCT/P enforcement,
manufacturers should ensure that their
advertising claims align with FDA’s regulatory
framework. In particular, their advertising
should be consistent with the definition of a
361 HCT/P – that is, they must: be minimally
manipulated; be intended to serve the “same
basic function” in the recipient as in the donor;
not be combined with another article except
where explicitly permitted in the regulation;
and not have a systemic effect or depend on
the metabolic activity of living cells for their
Mike Druckman
Partner, Washington, D.C.
Meredith Manning
Partner, Washington, D.C.
Ashley Grey
Law Clerk, Washington, D.C.
