May 12, 2023 Open Letter to the Food and Drug Administration

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OPEN LETTER TO THE FOOD AND DRUG ADMINISTRATION

Manipulation of the FDA Non-Prescription Drug Database for Marketing Purposes

Dear FDA Center for Drug Evaluation and Research, Office of Compliance:

Re: Regenerative Processing Plant, Regener-Eyes LLC, Regener-Eyes Pro, Regener-Eyes Lite

The Dry Eye Foundation is a 501(c)(3) nonprofit organization serving the ocular surface disease and ocular surface pain patient communities. Our activities include public education about eye drop safety. (1) (2)

We are writing to urge you, as a matter of public safety, to review and remove two biologic drugs from the Food and Drug Administration’s public over-the-counter drug listing database. We have communicated with the FDA regarding this matter in the past (3).

Regener-Eyes products are unapproved biologic drugs

On April 6, 2022, FDA’s Center for Biologics Evaluation and Research (Jurisdiction Office) shared with us their position that Regener-Eyes eye drops are regulated by FDA and that amniotic fluid products require premarket approval in order to be marketed for any medical application. (4)

On October 5, 2022, CBER sent an Untitled Letter to Regener-Eyes LLC stating, among other things: “Your product is not the subject of an approved biologics license application (BLA), nor is there an IND in effect for your product.” (5)

On April 10, 2023, CBER issued a Public Safety Notification on Amniotic Fluid Eye Drops with specific reference to Regener-Eyes LLC. (6) This notification stated, among other things:

“...manufacturers are marketing and distributing amniotic fluid eyedrops to treat, mitigate, or cure diseases or conditions such as dry eye disease without the required premarket review and approval, raising potential significant safety concerns.”

Regener-Eyes products are listed as OTC drugs on DailyMed

OTC drug entries for Regener-Eyes Lite and Regener-Eyes Pro eye drops have been active on DailyMed since 2021. (Attachment A)

Each Regener-Eyes OTC drug listing displays an inactive ingredient with no UNII (Attachment B) i.e. ingredient not found in the FDA’s ingredient database. In the first version of each listing, the ingredient with no UNII is “d-MAPPS™”, identifiable as a biologic substance (amniotic fluid). (7) In the second and third iterations of the listing, introduced in 8/2022 and 1/2023 respectively, the ingredient with no UNII is “Tonicity Solution”, an unknown substance which the company describes as proprietary. (Attachment C)

Regener-Eyes cites OTC listings as evidence of FDA regulatory compliance

In order to substantiate the safety and efficacy of its products, Regener-Eyes has long represented to the public and to physicians that its products are OTC drugs that comply with all FDA regulatory laws. (Attachment D)

In a recent marketing email (Attachment E), Regener-Eyes claims that their products were recently “reviewed and granted an OTC Drug Monograph Final status from the FDA with an indication To Relieve Dryness of the Eye”, and the email contains a hyperlink (8) to the National Drug Code Directory as evidence. Regener-Eyes describes this imputed FDA action as a “huge milestone”.

As a matter of public safety, we urge you to immediately remove Regener-Eyes’ drug listings.

Sincerely,

Sandra Brown MD - Medical Advisor

Rebecca Petris - Executive Director