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Unapproved Wound Care Products Flood the Market

— Expert: Closer regulation could prevent many amputations

MedpageToday

Treating nonhealing, unresponsive wounds requires that physicians have an intimate knowledge of the products available to stimulate healing and stop chronic wounds from advancing to the point of widespread infection and limb amputation. But in order for clinicians to do their jobs to the best of their ability, it is imperative that the wound care products they use do what they say they do.

The importance of this issue cannot be overstated: 29 million Americans are living with diabetes, according to the CDC, and one in four are not even aware of their diabetes diagnosis. One-fourth of those living with diabetes will develop a diabetic foot ulcer, and an astounding 14%-to-24% of those people will face an amputation.

Unfortunately -- through no fault of their own -- many in the wound care profession are not getting the full story behind the products they are using to treat the most hard-to-heal wounds.

A dizzying array of wound care products has flooded the marketplace in recent years, with untested and unproven claims about their wound healing capabilities. The manufacturers of these allograft products have effectively bypassed years of careful research and clinical trials requiring hundreds of millions of dollars in investment, as well as the regulatory authorizations necessary to be legally marketed as wound healing therapies.

On the flip side, a small number of manufacturers have done things the right way and developed products that are rigorously tested and FDA-approved. These advanced living-cell products have been scientifically proven to heal chronic wounds when less expensive and less sophisticated options have failed.

Due to a current regulatory loophole, non-FDA-approved products are able to make the same wound healing claims as FDA-approved living cell therapies, and many doctors do not know or understand the difference because of the way the products are marketed.

Allograft products have flown largely under the regulatory radar due to a longstanding FDA process that's long overdue for revision. Under this process, companies are permitted to self-designate their own products under one of two categories: either human cell and tissue products ("HCT/Ps") that require FDA premarket approval, or those that do not (referred to as "").

By self-designating "Section 361" status for products that do not, in fact, qualify as such, allograft distributors have been able to skirt the FDA approval process while making unproven claims about their wound healing capabilities. Doctors and their patients need to know this, and the FDA has an opportunity -- and a responsibility -- to stop it from happening.

The real-life consequences of this muddy policy issue are pretty straightforward: When presented with two products claiming the same outcomes, providers will of course lean toward choosing the less expensive option. But making the wrong choice when a company has offered misleading efficacy claims ultimately impacts the patient. When unproven or clinically inferior products are used, patients lose healing time, infection can worsen, and the risk of amputation becomes greater.

The FDA must act to make regulatory changes to keep patients safe. The agency has the opportunity to do so as it works to finalize industry guidance that will clarify what qualifies as a true Section 361 HCT/P. It is critical that the FDA has the authority to prevent Section 361 HCT/P products from misbranding themselves, and that adverse event reporting for these products be expanded.

It's time to institute regulatory oversight that helps doctors make informed decisions, and protects America's diabetes patients from having to face avoidable amputations.

The risk for patients is simply too great.

, is the assistant medical director at St. Joseph's Hospital Center for Wound Care and Hyperbaric Medicine in Syracuse, N.Y. She has a financial relationship with Organogenesis, a wound care products firm, but did not work with the company on this commentary.