I previously posted links to the video of the FDA’s recent Wound Healing Workshop. It was a fantastic event. The Workshop is the result of a Science Strategies program launched by the Office of New Drugs (OND) in The Center for Drug Evaluation and Research (CDER), the Division of Dermatology and Dentistry. In collaboration with other FDA divisions, their goal is to assess areas of unmet need in the product development pipeline for wound healing. In other words, they are asking themselves and us, “where are the gaps in the development of drugs and devices to help heal chronic wounds?”

I know most people will not have time to watch hours of video but the individual presentations are short (I’ve previously posted the agenda and the links to the recording). The FDA and wound healing experts attempted to describe the landscape of problem wounds and review current standards for product development in the field, identify the challenges of implementing and conducting clinical trials, discuss potential solutions to them, and explore how current research in wound healing might promote innovative product development.

The FDA is seeking comments and has listed in the Federal Register specific questions to which they’d like input.

Comments can be submitted by anyone including patients – either electronically or via mail.

How to Submit Electronic Comments:

• Open the link to the FDA regulations
• Enter FDA-2021-N-1212 in the search box and select the Documents box below the search bar before clicking ‘search’
• The full FR notice document will appear
• Click on the Comments Box below the FR notice and start typing!

How to Submit Written/Paper Submissions:

• Address Mail/Hand delivery/Courier (for written/paper submissions):
• Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852
• All submissions received must include the Docket No. FDA-2021-N-1212 for “Wound Healing Scientific Workshop.”

The FDA will all the comments, except for information submitted, marked, and identified, as confidential, if submitted as detailed in their instructions.

Why bother to do this? I will give you one example. For understandable reasons (meaning, because the FDA sets it up this way) nearly all research in wound healing focuses on venous leg ulcers and diabetic foot ulcers. Unfortunately, these two problems represent a small fraction of the chronic wound problem in the USA. Most of the wounds suffered by our patients do not get a tidy label – they are symptoms of their underlying disease. As long as the FDA sets up a system that requires a tidy “name” for a wound, we will never have any innovative treatments for 85% of the patients. And if the FDA doesn’t “clear” or “approve” a treatment, insurance doesn’t pay for it. Everything comes down to how we set up the system.

So, I’ll ask you this question – do wounds HEAL by different processes based on what we call them? Where should efforts be directed for new product development?

Remember, the goal is to find solutions – and not just to complain. The FDA is listening so let’s provide useful, thoughtful input.

Caroline Fife, M.D.

Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos

The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.