The U.S. Food and Drug Administration on Wednesday announced an innovation challenge to address the national opioid epidemic.
Specifically, FDA is looking to the developer community to build digital health technologies, such as medical devices, diagnostic tests and mobile apps to help stem the opioid crisis. The intent is to provide unique approaches to detecting, treating and preventing addiction, addressing diversion and treating pain.
As of March 2018, the most recent statistics on opioid use from the National Institute on Drug Abuse showed that 115 people in the U.S. die every day after overdosing on opioids. According to the latest statistics, opioid overdoses increased 30 percent from July 2016 through September 2017 in 52 areas in 45 states. In the Midwest, opioid overdoses increased 70 percent from July 2016 through September 2017.
“Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “We must advance new ways to find tools to help address the human and financial toll of opioid addiction.”
The challenge is open to products in any stage of development, from concept to testing, including developers of currently marketed devices interested in demonstrating that their tool has an improved benefit-risk profile as compared to opioids in the management of pain.
Gottlieb offered as examples medical devices that can effectively address local pain syndromes, which in some cases could supplant the use of systemic opioids.
Also, new approaches might include diagnostics to identify patients at increased risk for addiction, treatments for pain that eliminate the need for opioid painkillers, treatments for opioid use disorder or symptoms of opioid withdrawal, and also technologies that can prevent diversion of prescription opioids.
Developers accepted into the challenge will work with FDA review divisions during the development and evaluation of the proposed product. In addition, Breakthrough Device designation will be granted to those devices that meet the statutory criteria for designation without submission of a separate application. In most cases, the agency anticipates that applicants will eventually submit one or more formal applications to the FDA, such as an investigational device exemption, De Novo, premarket clearance (510(k)) or premarket approval application.
“This new effort builds on the success of previous work to take a collaborative approach to promoting medical device innovation and safety, such as the 2012 challenge that led to multiple new approaches to treat life-threatening, end-stage renal disease,” noted Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “The FDA stands ready to provide significant assistance and expedite premarket review of applications to help bring innovative devices that, if properly instituted, could help those at risk for addiction or treat those who might develop opioid use disorder,” he added.
Over the past few years, the FDA has cleared, granted or approved more than 200 devices related to the treatment or management of pain, including 10 with new or novel technologies, such as brain and spinal cord stimulators that can relieve pain and reduce the need to administer opioid drugs to patients suffering from either acute or chronic pain. The FDA also recently granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal.
For its new innovation challenge, the FDA will accept submissions from June 1 through Sept. 30. The agency plans to announce the selected applicants in November 2018. Submissions will be evaluated by a team from the FDA’s Center for Devices and Radiological Health based on the product’s feasibility, potential public health impact, and novelty of the concept.
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