FDA Announces Innovation Challenge as Part of Efforts to Combat Opioid Crisis

The US Food and Drug Administration (FDA) has announced an innovation challenge as part of its efforts to address the ongoing opioid epidemic in the United States, with the goal of inciting the development of new medical devices, diagnostic tests, and health technology.

The challenge is part of the FDA’s current work to try to reduce the range of the opioid crisis and is in support of multiple overarching goals of the U.S. Department of Health and Human Services' Five-Point Strategy to Combat the Opioid Crisis.

The agency hopes that these innovations could provide new solutions for the detection, prevention, and treatment of addiction as well as the treatment of pain. Although there have been recent advances in the areas mentioned, the agency noted that there is still a great need to bring new products to market.

Companies that take up the challenge put forth by the FDA will be selected to participate in the new program and will work closely with the agency to “accelerate the development and review of their innovative products,” according to the FDA. Additional incentives will be provided for developers to invest in the addiction crisis space, it noted.

“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. We must advance new ways to find tools to help address the human and financial toll of opioid addiction,” said FDA Commissioner Scott Gottlieb, MD, in a statement. “For example, better medical devices that can effectively address local pain syndromes can, in some cases, supplant the use of systemic opioids. This can help reduce overall use of opioids. This innovation challenge is an example of the FDA’s commitment to an all-of-the-above approach to confront the opioid epidemic, including helping those currently addicted to opioids and preventing new cases of addiction. We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, that can contribute in novel and effective ways to help reduce the scope of this crisis.”

Proposal submissions are being encouraged and can include products such as identification and risk evaluation tests, treatments that eliminate the need for opioid-derived analgesics, and therapies for the symptoms of opioid use disorder and withdrawal. The FDA is also seeking the submission of devices that can be used to prevent the diversion of prescriptions.

Submissions can include products in any stage of development and will be accepted from June 1, 2018, through September 30, 2018. The selections will be announced in November of this year and will be assessed by FDA’s Center for Devices and Radiological Health based on feasibility, potential public health impact, and novelty of the concept.

Those selected will receive heightened interaction with the agency during the process of development. Additionally, those products that are accepted will be given Breakthrough Device designation.

“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,” Jeff Shuren, MD, JD, the director of the FDA’s Center for Devices and Radiological Health, said in a statement. “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. We also hope that in turn, these novel products may also help pave the way for the development of future products that build on the latest technologies.”