FDA Halts Osiris’ Grafix Human Cell Band Aid Marketing, Questioning the Classification of the Product

Osiris Therapeutics has been marketing a special band-aid that they claim promotes the healing of a variety of wounds, ranging from burns to diabetic foot ulcers. The band-aid is manufactured with various growth factors, proteins, and stem cells that are meant to stimulate more rapid healing.

The FDA, however, recently sent a letter to Osiris addressing how the company is classifying and promoting their product. Osiris had treated Grafix as if it fell under the FDA’s definition of ‘HCT/P’ (human cells, tissue, and cellular and tissue-based product), which meant that they didn’t need a regulatory review for it before putting it on the market. However, what the FDA asserts in the letter is that different Grafix products don’t meet the criteria for HCT/P. One issue raised was that the company’s manufacturing process apparently alters some of the tissues to a greater extent than would be permissible by HCT/P guidelines.

Osiris apparently has reached a deal with the FDA allowing Grafix to remain on the market; as part of the deal, the company has agreed to obtain a Biologics License Application (BLA) and will submit clinical data ostensibly demonstrating the safety and effectiveness of their product. They’ve already conducted at least one study of their own, which will need to be scrutinized to see if it meets rigorous scientific standards.

The company’s marketing of Grafix, and the FDA’s response, raises some important issues, including the following:

When it comes to products involving tissues from people or other living organisms, there needs to be intense scrutiny about how these tissues are used and to what extent they’re modified; for instance, companies can’t claim that the tissues in a product have been minimally modified when in fact they’ve undergone quite a bit of processing (as defined by current regulatory standards).

Medical manufacturers often try to push their products as quickly as possible into the market, and attempt to sidestep or expedite regulatory reviews. For the sake of patient safety, they need to be called out when they do this.
Any product safety research a company submits to the FDA will ideally be conducted by an independent third party, not by scientists affiliated with the company. Whenever a company comes out with research claiming the benefits of their product, we have to scrutinize the study for flaws in design and potential biases affecting the outcome.

If you’re dealing with the negative effects of a medical device or are troubled by a company’s misleading promotion of a given product, you can reach out to experienced lawyers to discuss your concerns and seek advice on how to proceed.