ARM Asks FDA for Clarification on Draft Guidance on Minimal Manipulation

Alliance for Regenerative Medicine

Alliance for Regenerative MedicineIn the last few months the FDA has taken steps toward crystalizing regulatory oversight of stem cell and more broadly cell and tissue-based therapies.

These steps come in the form of several draft guidances  (see herehere, and here.

The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation. For example, ARM has requested that the FDA clarify the term “main function” for human cell and tissue products (HCT/Ps). ARM rightly points out that HCT/Ps can have more than one function. For example, adipose tissue in the draft guidances was said to have a structural function, but fat of course also has roles in metabolism.

In the Press Release it says:

“We’re pleased to see the FDA provide additional insight into their regulatory decision-making process on this important topic,” said Michael Werner, executive director of ARM. “We do ask, however, that the FDA provide clarity on a number of important points within the guidance, given the complexity, significance and impact of this issue. We also encourage FDA to hold a public hearing to engage with stakeholders in a full airing of the topic.”

The idea of public meetings is also potentially worthwhile. More clarity and engagement from the FDA is always a good thing.
One of the challenges for the FDA in regulating these products is that both compliant biotechs such as those represented by ARM and unlicensed stem cell clinics fall under a shared regulatory umbrella.