FDA Takes Aim at Popular Scar Fading Gel

MakenzieR on 15 Dec 2011 at 4:00pm

HybriSil, a prescription-only scar treatment gel, has come under fire for not complying with FDA standards.

In a letter dated November 17, 2011, the FDA states that the product’s maker, Crescendo Therapeutics, “does not have written procedures in place for the surveillance, receipt, evaluation, and reporting to FDA of adverse drug experiences pertaining to the drug HybriSil.”

They’re also accused of

  • Marketing and distributing a new drug without an FDA-approved application
  • Misbranding

Eyebrows are raised when the FDA calls out a product, so we turned to the plastic surgeons on our Media Advisory Panel for their thoughts on HybriSil.  They were slightly mixed.

HybraSil FDA scrutinyHybriSil is the best post-surgical product I have ever used...I have noticed a dramatic improvement in the appearance of scars and recommend it for everyone who has a surgical scar or other skin injury,” said Dr. Mitchel Goldman.  “I have used it personally after a bicycle accident gave me a huge ‘road rash’ and it healed without any evidence that the accident ever occurred.”

Dr. Grant Stevens agrees.  He said it’s a “great product,” and that he was using it on himself right then.  Also that he thinks the whole FDA letter has been “way overblown.”

On the flip side, Dr. Phillip Haeck doesn’t use or prescribe it, but said because it has silicone and steroids in it, he “would be personally reluctant to put a steroid cream on a healing scar every day.”

We spoke with Eric Glader, the president and CEO Crescendo Therapeutics.  All he would say at the time of publication is that they have sent a formal response to the FDA, and are waiting for approval from the latter to share that message with press.

So what should you do if you’ve been using HybriSil and loving it? 

It's a little trite, but since there's no clear answer here, do whatever is comfortable for you.

If you believe the FDA is the wisest of them all when it comes to product safety, put it back on the shelf.  If you have the “if my doctor uses it...” mentality, follow Dr. Goldman and Dr. Stevens' examples and keep on keepin' on.  After all, there are a whole host of supplements and products we use in/on our bodies that haven't been blessed by "The Man."

UPDATE 12/19/11: Just received a response from Eric Glader of Crescendo. Full text below, but the gist is that they believe a competitor is pushing this FDA warning letter around, that Crescendo has been compliant with the FDA in terms of making and marketing HybriSil, and they do NOT plan to pull it off the market.  They've responded to the FDA's warning letter (see below). 

Photo credits: Hyrck on flickr; HybraSil

Comments (5)

I spoke to my PS 8/8/12 at my third, yes I said third consult. He had recommended HybriSil last year when we had started planing my surgery's and said it was back on the market, they had just changed the label.
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"During a recent FDA inspection, FDA noted that Crescendo did not have a written procedure for reporting adverse drug events. Crescendo told the Agency that it had not had any reportable events to date..."

Uh, if they don't have a procedure for reporting adverse events, it's no wonder that they don't have any reportable events. That would be like the police taking down 911, then claiming crime went down because they weren't getting any calls!

I'll end up going by the FDA findings, but that response is pretty much just spin, isn't it?
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Here is a response I just received from Eric Glader, president of Crescendo Therapeutics.  The gist, if you don't want to read it all, is that they believe a competitor is pushing this FDA letter around, and that they have been  compliant with FDA standards in regard to making and marketing HybriSil.  They are NOT planning to pull HybriSil off the market.


It has come to Crescendo's attention that a lot of false information is being disseminated regarding Crescendo's HybriSil (topical methylprednisolone) drug product.  We believe that information is being spread by our competitors whose product cannot fairly compete in the marketplace with HybriSil.  This information states that FDA has made a ruling that HybriSil is not a legal product, and that it will soon be removed from the market.  As described below, that is not the case.  Crescendo maintains that its HybriSil product is legally marketed, and has explained this in detail to FDA.

The false information concerns a November 17, 2012 Warning Letter that Crescendo received from FDA.  Warning Letters are not a ruling from FDA.  They are advisory letters FDA sends out when the Agency believes that there might be a problem with a regulated product.  These letters are not considered official enforcement action by FDA, and do not require companies to remove products from the market.  Recipients can and do respond to these letters to explain why FDA may be incorrect. 

The Warning Letter states three main issues that FDA has with Crescendo's product: 1) that HybriSil does not have an approved new drug approval application ("NDA"); 2) that it is mislabeled because it lacks an NDA; and 3) that the Company does not have adverse event reporting procedures.  All three of these allegations are incorrect.  Crescendo has responded to FDA's Warning Letter in detail, and has explained to the Agency why its letter was incorrect.  A brief summary of what was in that response is below.

HybriSil is not an illegally marketed unapproved new drug

Topical methylprednisolone acetate drug products such as HybriSil have a long history of safe and effective use.  This long history of use places these drugs in a special category of drugs that are exempt from the NDA process.  Federal law states that drugs require an NDA if they are not Generally Recognized as Safe and Effective ("GRAS/E") by "experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs."  Topical methylprednisolone drug products are GRAS/E, and were formally reviewed as a class and deemed safe and effective by an FDA expert panel in 1971.  FDA went further, and specifically approved the labeling package inserts for topical corticosteroid drugs (including topical methylprednisolone drug products) in 1981.  That "class label" was issued as an official FDA guidance, and demonstrates that FDA considered these drugs to be legally marketed, even though they did not have specific NDA approval.

Additionally, even if HybriSil were not a generally recognized as safe and effective drug, it would be in compliance with FDA's compliance policy guide ("CPG") for drugs without an approved NDA  That guidance provides criteria for drugs that FDA will not take action against, so long as certain conditions spelled out in the guidance are met.  HybriSil complies with FDA's guidance, and therefore should not be subject to removal from the market by FDA.

HybriSil is properly labeled

FDA's Warning Letter stated that HybriSil is misbranded.  Federal law (the Food, Drug, and Cosmetic Act) has certain requirements for prescription drug labeling, and the Warning Letter stated that HybriSil's labeling did not meet those requirements.  The Warning Letter states that "[b]ecause your product lacks a required approval application, it is not exempt under 21 C.F.R. § 201.115 from the requirements of section 502(f)(1) of the Act."  This statement is in error and misstates the applicable regulatory law.  Section 502(f)(1) requires that drugs be labeled with adequate directions for use (i.e., over-the-counter labeling).  The statute also gives FDA authority to promulgate regulations for exceptions to the adequate directions for use requirement.  21 C.F.R. § 201.115 provides one exception from the adequate directions for use, but not the only exception found in the regulations.  The regulation found at 21 C.F.R. § 201.100 also provides an exception to §502(f)(1).  This section of the regulations implements the Food, Drug, and Cosmetic Act § 503(b)(1) which provides an exception to adequate directions for use for properly labeled prescription drugs, whether or not they have been NDA approved.  Also, FDA's 1981 formal guidance on class labeling for topical corticosteroid drugs specifically states that the class labeling provides full FDA acceptance and recognition of labeling for drugs such as HybriSil despite the lack of NDA approval.

Crescendo has proper adverse event reporting procedures

During a recent FDA inspection, FDA noted that Crescendo did not have a written procedure for reporting adverse drug events.  Crescendo told the Agency that it had not had any reportable events to date, but that it would document its adverse events reporting procedure.  In a subsequent letter, the Company notified FDA that it now had the required written procedure.  FDA erroneously stated in the Warning Letter that such procedures did not exist, and Crescendo has now provided a copy of the procedure to the Agency to demonstrate the Company's compliance with FDA's regulations.

*          *          *

 

Crescendo believes that its methylprednisolone drug product HybriSil is legally marketed, and that it has addressed the issues raised by FDA in the November Warning Letter.  The Company plans to meet with FDA to resolve any potential remaining issues or misunderstandings.


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Where is the research behind this product? I could not find anything on pubmed or the manufacturer's website. While the anecdotal evidence appears appealing, it is appropriately insufficient for the FDA.
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I'm a practice administrator for a plastic surgery practice and can say that Hybrisil has been, hands down, the best scar treatment product that we've used in our practice and recommended for our patients--and we've tried them all--Scarguard md, biocorneum, scar fade, kelocote, etc. I was concerned when I learned about the warning letter so I shared it with my physicians. They agree with Dr. Grant's opinion that the FDA's letter was overblown and feel very comfortable prescribing Hybrisil and are going to continue recommending it because the active ingredient is safe, has been on the market for a long time, and this product, based on our clinics observations, has already proven itself.
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