New FDA Interview on April stem cell meeting & draft guidances

FDA draft guidanceBelow is a my interview with an FDA spokesperson on the upcoming April public meeting on the four recent draft guidances related to the regulation of HCT/Ps, including stem cell treatments.

This meeting and the draft guidances could have substantial impact on future regulatory frameworks for stem cell treatments so I thought it important to reach out to the FDA to clarify the process.

  • PK: When the FDA issues draft guidances is it a standard approach to have a public meeting of the kind that will be held in April on the four stem cell-related draft guidances?
  • FDA: No, this is not typical. But with these there has been such strong public interest that we decided to have a Part 15 hearing. This will allow us to hear from interested stakeholders. So for these draft guidances we will both have the docket (the opportunity for written public comments) and the public meeting.
  • PK: Does the agenda include everyone who requested to speak and is that why each speaker gets only about 3 minutes?
  • FDA: We have tried to accommodate everyone who expressed interested in speaking in person at the meeting. Time is limited as a result of the interest.
  • PK: What happens after the meeting and when the written comment period ends?
  • FDA: We will take into consideration and review all the comments as we finalize each of the four draft guidances.
  • PK: Once finalized, what happens next?
  • FDA: These finalized guidances will then reflect the FDA’s current thinking, but the guidances are recommendations and are not binding. Even after we finalize guidance, it can undergo future revision.
  • PK: How do you collate all the comments both in writing and at the meeting, along with the FDA’s own research on the matters at hand? I imagine it could be quite the task with hundreds of potential viewpoints from stakeholders.
  • FDA: Regulatory and policy staff go through all the comments, which is indeed a lot of work. For instance, on the recent review of blood donation deferral, we got something like 700-800 comments that were roughly equally divided. With the four draft guidances related to stem cells, our goal is to provide clarity through the guidance, which we hope will lead to development of safe and effective products.
  • PK: We’ve recently seen a change in Japan as relates to the regulatory scheme for review of stem cell and regenerative medicine products. This has been predicted to speed things up there, but there will be less review before products go into patients. Does the FDA take into consideration paradigms in other countries?
  • FDA: In general we work closely with our regulatory counterparts in other countries.
  • PK: Can you predict a timeline for finalizing these four draft guidances?
  • FDA: I can’t predict the timing. These are a priority though.

4 thoughts on “New FDA Interview on April stem cell meeting & draft guidances”

  1. @Paul. Wow! So what do we have here? Non Binding guidance with no enforcement? Selective enforcement with no consistency? A big waste of time? Was the FDA person knowledgeable enough to understand the big picture here?

  2. Thanks Paul,

    Can you explain the recent FDA stem cell clinic enforcement letter in light of this statement in your interview : “but the guidances are recommendations and are not binding. Even after we finalize guidance, it can undergo future revision.”

    The draft guidance is clear about the use of SVF but how do non-binding recommendations relate to real world enforcement? If not binding then what’s the point?

    1. @WST,
      I had the exact same question and I asked it, but no luck. FDA cannot comment on that kind of situation. I tried…

      It’s difficult to figure out why sometimes the FDA will take a fairly sizable step like a warning letter and then other times it won’t.

      I have some backstory on that warning letter, but aiming to get more information before I could post on it.

  3. Thanks for sharing Paul. Disappointing that all of this will only result in revised non-binding guidelines and not more enforceable regulations.

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