This is big news and should be on the front page of all newspapers and yet, I bet you had no idea this was about to happen.
The FDA is currently trying to block you from using your OWN cells and tissue (what the FDA calls “Human Cells, Tissues and Cellular and Tissue-Based Products” or “HCT/P’s).
Why? They say it’s for safety. Translation, we can’t have nice things because a couple of people have done stupid things. This is serious and we need to do something about it. See below how you can use your voice and make a difference.
Once stem cell use became the norm, the FDA decided to regulate the process and three different regulatory pathways for HCT/P’s were born. Their regulations “introduced two biologic/analytical binary concepts which it uses as criteria for determining which of the three regulatory pathways applied to a particular use of an HCT/P: Homologous vs. non-homologous and minimally manipulated vs. more than minimally manipulated.” But in the last couple of years, the FDA has issued four draft guidance documents to help clarify the meaning of homologous/non-homologous use and more than minimally manipulated.
However, they didn’t just clarify the terms, they rewrote the rules which will now erase some of the most popular and effective medical procedures we have, including the most popular: post-mastectomy breast reconstruction procedure with flap surgery.
From the article:
“Flap reconstructive breast surgery takes fat (usually belly fat) and builds up the breast. Under the guidance documents, the main function of fat is structural. The main function of a breast (in a woman) is lactation. (Some presenters of the female persuasion who presented at the stem cell public hearing were really annoyed about that characterization). Lactation is a different function than the function of belly fat (structural). Therefore the use the flap procedure is non-homologous, which means the use has to obtain full FDA approval before it can be used outside of FDA-approved clinical trials. Many of the presenters used this as an example of why the draft guidelines are wrong.”
To quickly explain, the use of an HCT/P is homologous if the use of the material in the donor location is the same as in the recipient location and it’s non-homologous if the use the cell had in the donor location was different from the intended use in the recipient location. The other distinctions, minimally manipulated and more than minimally manipulated, were too ambiguous but no one seemed to care.
But now, under the new documents, separating the stem cells from the fat constitutes “more than minimal manipulation” of the HCT/P and requires full FDA approval. That means you may not use your own stem cells, YOUR BODY, as you see fit because the FDA sees them as an unapproved drug.
So, what do we do? We need to make sure the FDA rescinds the draft guidance documents and starts over. The public hearing of the documents ended last Tuesday, September 13, 2016, but the public comment period is open until September 27th so if there is a CHANCE you might want to use your own stem cells or other body parts in the future, or if you know anyone how might need them, or if you think that what the FDA is doing is a bad idea, then write, fax or email the FDA and tell them. Here are some suggested topics to bring up from our friends at Huffington Post:
- Withdraw the four HCT/P guidance documents
- Get out of the business of regulating a person’s use of his own body parts
- Any opinions you might have about where they should place their draft guidance documents, or such other opinions you might have on this regulatory exercise, mindful of the rules of polite discourse, based on your discretion and/or temperament.
To send a comment via mail:
“Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions: All submissions received must include the Docket No. FDA-2015-D-3719 for “Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Rescheduling of Public Hearing; Request for Comments.”
You can also email them: [email protected]
And if you’d like to read the entire draft, go here.
Source: Huffington Post