Challenge Accepted! FDA Launches Innovation Challenge to Help Curb Opioid Abuse
With the ever-increasing concerns of the opioid crisis facing the United States, the U.S. Food and Drug Administration (FDA) has launched an “innovation challenge” to spur on the development of medical devices that can combat the crisis and help prevent and treat opioid use disorder.
Beginning today and running through Sept. 30, the FDA is accepting applications for medical devices that can be used to curb the use of opioids. According to the U.S. Department of Health and Human Services, 116 Americans die daily from opioid overdoses. In 2016 there were an estimated 64,000 drug-related deaths in the United States, with the highest increase related to opioid drugs. A recent report released by the U.S. Centers for Disease Control and Prevention shows opioid-related emergency room visits spiked 30 percent across the states between July 2016 and September 2017.
The FDA’s challenge is an attempt to significantly decrease the number of opioid addictions and related deaths. Through the challenge, the FDA is seeking to provide medical device makers an “an opportunity to work directly with the FDA to accelerate the development of innovative products, such as diagnostics to identify patients at increased risk for addiction, non-opioid pain therapies for acute or chronic pain, treatments for opioid use disorder or symptoms of opioid withdrawal, as well as devices that monitor the use and prevent diversion of prescription opioids.”
“The FDA remains committed to addressing the national crisis of opioid addiction on all fronts and this challenge is part of the FDA’s ongoing work to reduce the scope of the opioid crisis,” the regulatory agency said.
In its announcement, the FDA said it is looking for devices that can lead to prevention and treatment of opioid use disorder. Medical device makers who already have an approved product on the market and believe their product had an “improved benefit-risk profile” compared to opioids are also encouraged to apply, the FDA said. Applicants that are accepted into the FDA’s challenge will receive enhanced communications with the FDA review during the development of the proposed product. Additionally, Breakthrough Device designation will be granted to those devices that meet the statutory criteria for designation without submission of a separate application, the FDA said.
The FDA said the number of applications selected for the challenge will be determined by “the quality of applications received and available FDA resources.” The FDA will announce the device proposals that are selected for the challenge in November. The FDA added that it will host a webinar for medical device makers on July 25 in order to discuss the challenge in an open forum. Details on the webinar can be found on the FDA’s Center for Devices and Radiological Health Webinar website.