Nation’s Leading Advocacy Organization for People with Limb Loss Urges FDA to Ensure Safety, Efficacy and Transparency of Chronic Wound Care Products

Kevin Manuel In The News

-Vascular Disease (Including Diabetes) the Leading Cause of Limb Loss in U.S., According to Amputee Coalition-

The  — the leading advocacy organization for Americans affected by limb loss — today urged the Food and Drug Administration (FDA) to finalize draft guidance that would ensure transparency and efficacy of chronic wound care products used to treat millions of Americans at risk for amputation due to non-healing wounds like diabetic foot ulcers (DFUs).

“As the nation’s leading advocate for amputees and those at risk of limb loss, we believe that transparency related to any product – including wound care and healing – is critical for people making decisions about care. The FDA’s proposal on wound care products would ensure patients and providers have the information they require to confirm that marketing claims are substantiated and adequate care is provided,” said Jack Richmond, Interim President & CEO for the Amputee Coalition. “Lack of transparency, regulatory clarity and enforcement, poses significant challenges for patients who need to rely on safe and effective therapies to achieve wound healing and avoid lower limb amputation.”

The Amputee Coalition’s 2016 white paper published by the Amputee Coalition’s Limb Loss Task Force, highlights the fact that vascular disease (including diabetes) is the leading cause of limb loss in the United States.  The Centers for Disease Control and Prevention (CDC) estimate 29.1 million Americans live with diabetes, which can result in life- and limb-threatening DFUs. In fact, of the nearly one in 10 Americans living with diabetes, between 4 and 10 percent will develop a DFU at some point in their lives. Approximately 73,000 amputations are performed annually on U.S. patients as a result of non-healing DFUs, according to the white paper.

In many instances, DFU-related amputations can be preventable with the use of advanced wound care products.  Ensuring transparency between advanced wound care products that are FDA approved and scientifically proven to safely and effectively stimulate wound healing and those that do not go through this approval is crucial to preventing further infections and amputations. However, a number of products on the market today are marketed for wound healing indications without having undergone FDA review or clinical trials.  This has led to a proliferation of unapproved products into the wound care marketplace and causes significant confusion among patients and clinicians who are battling non-healing wounds to prevent amputation.

In response to concerns from the Amputee Coalition and other stakeholders, the FDA convened a two-day public meeting this week to gather feedback on draft guidance related to the regulation of human cells, tissues, and cellular and tissue products (HCT/Ps) in the United States. Clinicians, scientists, and patient advocates who were given the opportunity to speak echoed the Amputee Coalition’s message in urging the FDA to close the regulatory loophole and ensure transparency for products that qualify as Section 361 HCT/Ps or those that have not gone through the FDA approval process and may bear unsubstantiated or misleading efficacy claims.  The way to accomplish this is to create clear guidance for industry, which the FDA has already proposed in its drafts.

“Our mission includes helping to prevent primary and secondary amputation, and we applaud the FDA’s leadership in developing draft guidance that would help patients make informed decisions by relying on accurate wound healing product marketing backed by the government’s clinical efficacy and safety standards,” said Richmond. “We urge the Agency to finalize the guidance as soon as possible to provide transparency in advanced wound care products and to ensure the safety, health and wellbeing of millions of Americans battling chronic wounds and preventable amputations.”