FDA to Regener-Eyes: “Can’t lawfully market it until proven safe, pure and potent.”

FDA’s 10/5/2022 letter

See Untitled FDA letter to Regener-eyes, dated 10/5/2022

Progress

I am very pleased to report that, as anticipated, the FDA has begun to address Regener-Eyes. As previously reported, FDA has sent warning letters to two other biologic eye drop manufacturers - Vitti Labs, manufacturer of Ev-Opti Drops and Biolab Sciences, former manufacturer of StimulEyes.

What the FDA told Regener-Eyes, in a nutshell

1. To lawfully sell Regener-Eyes, you have to have a valid biologics license.

You don’t, so you can’t.

And you can’t get one till you prove it’s SAFE, pure [manufactured properly and consistently] and potent [works].

2. To even use Regener-Eyes in clinical trials, you have to have an IND.

(Investigational New Drug Application)

You don’t have that either, so you can’t do that either.

So you really can’t legally use it for anything at all right now.

3. Is there any part of this you do not understand?

We’ll be happy to explain. We’re offering five different ways to help you.

4. Think about this and get back to us within 30 days.

Oh, and by the way [footnote], if it’s amniotic fluid rather than placenta, we can assure you that we already know every possible way to turn acronyms like HCT/P into smoke and mirrors in order to pretend to be compliant (since the Regenerative Medicine industry has given us years of practice) so do us a favor and don’t waste our time.

What went down last week

On Wednesday, 10/5/2022, FDA sent Regener-Eyes a nastygram (pictured below),

On Wednesday, 10/5/2022, Regener-Eyes LLC sent us a nastygram. It consisted of a three-page Cease and Desist Demand Letter wherein they respond to my Open Letter, refuse to say what is in Regener-Eyes, and threaten to sue the Dry Eye Foundation and everyone associated with it.

We also noticed that by the end of the week, Regener-Eyes had removed all the remaining references to biologicals - in fact all medical references of any kind, and even things like mechanism of action - from Regenereyes.com, which is looking remarkably naked at this point.

There’s an old proverb about shutting the barn door after the horse’s bolted. CBER’s internet surveillance team presumably knows how to use waybackmachine at least as well as we do.

The letter is the first step in a process

The FDA letter to Regener-Eyes isn’t a classic Warning Letter, which is a step that normally only happens some time after an on-site inspection. That is a step we are anxious for, but we understand things are still very backed up at CBER. Meantime, this one came from the biologics division’s internet surveillance team.

We anticipate that responding to the FDA will keep Regener-Eyes’ lawyers busy enough that they at least stop bothering us.

Rebecca Petris