Regulatory Affairs

While I was settling in at my new job with Greyledge Technologies in Colorado, the FDA held a two-day stakeholder meeting to review four draft guidances the Agency wants to finalize. The four draft guidances are (in the order they were issued):

Same Surgical Procedure Exception (October, 2014; source)

Minimal Manipulation (December, 2014; source)

Adipose Tissue Uses and Abuses (December, 2014; source)

Homologous Use (October, 2015; source)

All of the draft guidances refer to elements of a law known as 21 CFR 1271, which was published in the Federal Register on January 19, 2001. So, the law of the land in dealing with certain types of human-derived materials useful for regenerative medicine has been on the books since 2001, with a modification in 2005.

You might be wondering why the FDA felt the need to write draft guidances for 1271. The charitable answer is that the FDA genuinely tries to ensure that its laws are understandable and uses Guidances as a means of letting the public and, more specifically, stakeholders in the industry know what the FDA’s thinking is on the topic of the Guidance.

However, in this case, I suspect the FDA got fed up with the blatant disregard of the language in 1271 by a whole host of entities, including companies who subsequently have received Untitled Letters concerning products that the companies decided to market without the proper pre-market studies. Or it might have to do with networks of physicians who believe that because they wear a white lab coat and are treating patients that everything they do is sacrosanct and beyond the reach or scrutiny of the FDA.

In any event, the FDA issued the four draft guidances listed above. Needless to say, the folks that had been doing pretty much as they wanted eventually took notice. And they started to complain to their government representatives. In turn, these public officials called up the FDA and asked, “What’s up?” The FDA got the hint and scheduled a single day hearing (in April, 2015) on the draft guidances to which they received hundreds of requests to speak. Figuring they would look bad if they gave speakers a minute each to say their piece, the FDA regrouped and expanded the Workshop to two days, which just recently was held on September 12 and 13. The foregoing is my somewhat tongue-in-cheek version of events that led up to the two-day hoedown.

I will address at a later date my observations on the comments made during the sessions, since for one thing, I haven’t had a chance to listen to the videocasts. But I have seen comments made by Dr. Chris Centeno, who was a speaker at the Workshop, and who shared a reference to blog posts made by Mr. Richard Jaffe, Esq. I reviewed Mr. Jaffe’s comments in a post he wrote on September 13. And I couldn’t believe how peculiar Mr. Jaffe’s comments were. So, I would like to address just a couple of the errors Mr. Jaffe perpetrates in his post, since the intent of my posts on the Greyledge blog is to provide a public service in terms of educating the public about scientific, clinical and regulatory aspects of regenerative medicine, and more particularly, translational cell therapy.

And, boy, do Mr. Jaffe’s comments need to be dealt with. This is the link I used to gain access to the post, but I will provide verbatim excerpts as needed. He wrote:

“Under the actual rule (1271.15) same day surgical procedures can do non-homologous and more than minimally manipulated. At least these two terms are not in that rule. Legal Method 101 instructs that if terms are in 1271.10 but not in 1271.15, then the 1271.10 terms and restrictions cannot be read into 1271.15.”

I will defer to Mr. Jaffe, who is an attorney, about the lessons of Legal Method 101, but I can read English and it is clear to me that 1271.15 incorporates the two terms by reference. Furthermore, Mr. Jaffe has conducted a very selective reading of 1271 in order for him to take what I find to be a breathtakingly extreme position that as long as you are a physician you can do whatever you want, even if the procedure involves non-homologous and more than minimally manipulated processes performed to create the HCT/P for use in the same patient and within the same day surgical procedure.

I will provide a full analysis of what I believe to be the error of Mr. Jaffe’s ways in the next post.

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