Osiris Backs Down After Accusations of Misleading Marketing

On Sept. 26, Osiris Therapeutics Inc. received an untitled letter from the U.S. Food and Drug Administration (FDA) which instructed the company to cease making un proven medical claims about its Grafix product. The company was marketing the wound-healing patch as a stem cell product, while, in fact, it is not. 

Many industry players took note of this misleading marketing when the product was released earlier this year. In August, Stemcellassays.com blogger Alexey Bersenev wrote:

“To me, there is no any piece of evidence that Grafix indeed ‘stem cell product.’ Based on what Osiris is making a claim about it? Based on presence of [mesenchymal stem cells] in the product? Well, let me tell you this – every piece of tissue mashed in a dish will contain some sort of stem cells and more likely they will be MSC or alike. Is it a valid reason to qualify  product as ‘stem cell product?’ NO! A drop of blood contains stem cells, but blood transfusion products are not “stem cell products”. Donor organs for transplantation contain stem cells, but they are not ‘stem cell products.’”

Grafix is not an FDA-approved drug or medical device: It is a bandage embedded with unmodified and uncultured cellular tissue derived from human placentas and other growth factors. As such, Osiris believed Grafix fit under the FDA’s definition of a human cells, tissue and cellular and tissue-based product, or HCT/P, which means it could be sold without regulatory review as a drug or medical device.

According to the company, after discussions with the FDA, the regulatory status of Grafix has been confirmed and the product will remain on the market as a wound cover for the treatment of acute and chronic wounds. For certain expanded indications for Grafix, Osiris has reportedly committed to submit a Biologics License Application (BLA). Osiris will leverage existing clinical data in the preparation of the applications, including data from Protocol 302, its multi-center, randomized controlled trial which demonstrated a 192 percent relative improvement in closure rate of chronic diabetic foot ulcers as compared to patients receiving conventional therapy, Osiris claims.

The FDA letter also exporessed concern over Osiris’ Ovation product, an ointment for wound care. Osiris officials stated Osiris will continue transitioning its Ovation product line over to the company’s newly launched OvationOS formulation and has agreed to complete this transition no later than the second half of 2014.

“We are pleased with the regulatory clarity this agreement provides and are excited to take this leadership role as we work with FDA in the evolving science and regulation of regenerative medicine,” said C. Randal Mills, Ph.D., president and CEO of Osiris. “This effort will set a new standard in transplantation and will further spotlight the clinical benefits and high quality this innovative technology offers.”

Osiris Therapeutics is based in Columbia, Md., and markets itself as a “stem cell company.”