The wound care market is flooded with products that claim to be superior in safety and efficacy to FDA-approved treatments, despite having little proof of such promises. According to a physician-authored blog on The Hill, this problem can and should be addressed by Congress.
The blog was authored by Shaun Carpenter, MD, the CEO of MedCentris, a wound care management company. Dr. Carpenter points out a wide discrepancy between wound care products, from FDA-approved, bioactive therapies made from living cells to less expensive and less sophisticated allograft products.
Both types of products are available to consumers because a longstanding legal process allows companies to self-designate as either human cell and tissue products, which require FDA premarket approval, or Section 361 human cell and tissue products, which do not require approval or formal adverse event reporting.
"As a physician who has spent more than a decade treating patients suffering from complex diabetic wounds, I am deeply concerned," wrote Dr. Carpenter. "My patients have no time to lose; they face the very real risk of infection and amputation without timely and effective treatments. When unproven or clinically inferior products are used, patients lose healing time, infection can worsen and the risk of amputation becomes greater."
Dr. Carpenter suggests Congress address this issue by:
1. Establishing a notification process requiring manufacturers to prove their products meet existing regulatory requirements for Section 361 human cell and tissue products
2. Give the FDA the power to sanction Section 361 human cell and tissue product manufacturers that misbrand themselves
3. Extend the FDA's adverse event reporting requirements for Section 361 human cell and tissue products.
"While it is easy to get lost in the minutiae of FDA regulations, there is only one question policymakers should consider: Will this policy ensure patients receive the most clinically appropriate care?" wrote Dr. Carpenter. "When it comes to chronic wound care, the answer is a resounding 'yes.'"
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