FDA to Hold a Public Hearing for a Quartet of Draft HCT/P Guidances: A Scorecard

By Jeffrey K. Shapiro –

For more than 10 years, FDA has regulated human cells, tissues, and cellular and tissue-based products (“HCT/Ps”) under 21 C.F.R. Part 1271.  Under § 1271.10(a), if four criteria are met, the HCT/P qualifies for regulation exclusively under Part 1271.  This status is advantageous, because an HCT/P regulated exclusively under Part 1271 does not have to undergo premarket review of any kind. 

The four criteria in 21 C.F.R § 1271.10(a) are: (i) minimal manipulation, (ii) homologous use, (iii) not combined with another article (with certain exceptions), and (iv) not having a systemic effect and not dependent upon the metabolic activity of living cells for primary function (with certain exceptions).

Last year, FDA issued three draft guidance documents intended to assist industry in understanding how FDA applies the regulation.  They addressed:

• Recommendations for meeting the minimal manipulation criterion, 21 C.F.R § 1271.10(a)(1).
• FDA’s current thinking as to how the four criteria in 21 C.F.R § 1271.10(a) apply to HCT/Ps produced from adipose tissue.
• Recommendations for meeting the “same surgical procedure” exception from Part 1271, found in 21 C.F.R § 1271.15.

Last week, FDA issued another draft guidance with recommendations for meeting the homologous use criterion in 21 C.F.R § 1271.10(a)(2).  All draft and final guidance documents regarding HCT/Ps can be found on FDA’s web site.

The three guidances listed above were not without controversy, particularly the recommendations relating to minimal manipulation.  Many in industry had urged FDA to hold a public meeting for fuller discussion.

Last week, FDA announced it would do just that, with a public hearing on all of these guidances set for April 13, 2016.  The announcement has full instructions for submitting written comments to the hearing docket and for signing up to attend and/or speak.  The hearing will be held under the Part 15 procedures, which allow both written submissions and oral presentations at the hearing to be entered into the administrative record.

FDA describes the purpose of the hearing as follows:

The purpose of this public hearing is to obtain comments on these four draft guidances. FDA is seeking feedback, both general and specific, from a broad group of stakeholders, including HCT/P manufacturers, tissue establishments, biological and device product manufacturers, health care professionals, clinicians, biomedical researchers, and the public.  For example, FDA would like comments on the scope of each guidance, including the particular topics covered, the particular questions posed, whether there are additional issues for which they seek guidance, and whether FDA's recommendations for each topic are sufficiently clear and consistent within and across documents to provide meaningful guidance to stakeholders.  In addition, FDA welcomes any comments that will enhance the usefulness and clarity of these documents.

In conjunction with the hearing, FDA is also reopening the comment period for all three draft guidances (and allowing comments on the new draft homologous use guidance) until April 29, 2016 – see here, here, and here.

There is no doubt that industry will want to comment on these draft guidances.  Commenters should remember that they may submit to the original dockets as well as the new public hearing docket.  Submissions to the hearing document can be provided up until April 29, 2016.  Some of the most valuable comments may come after the hearing, in response to statements made during the hearing.

In every comment, it will be particularly important to remind FDA that a guidance document is an opportunity to clarify a regulation such as 21 C.F.R. Part 1271, but it is not an appropriate proceeding to rewrite a regulation.  A number of commenters felt that the minimal manipulation draft guidance overstepped this boundary.  Hopefully, the final guidances will stay well within bounds of the regulation.