FDA Friday: FDA New Challenge to Help Combat Opioid Use Disorder
The Food and Drug Administration has recently launched a challenge to initiate development of medical devices to help combat against the opioid crisis. FDA is looking to medical device manufacturers to help protect and promote the public health by finding new ways prevent and treat opioid use disorder.
Many people are used to hearing “substance abuse” or “substance dependence,” but those terms have become outdated. Current terminology states that “substance use disorders” can be evaluated as mild, moderate or severe. Substance use disorder is defined by the repeated use of drugs and/or alcohol that ultimately results in significant impairment in many areas. The challenge that FDA is promoting focuses entirely on opioid use disorder, a very serious health condition that can have devastating outcomes. Opioids reduce pain perception and are a very effective pharmaceutical solution to certain medical conditions, however, when misused, can cause serious health effects and may lead to addiction. The lurking end to those who tamper with and misuse opioids is, unfortunately, overdose, which has become an increasing occurrence over the past 18 years. It is clear why FDA has focused on this disorder, and expressed a need for medical devices that can help put an end to the countless deaths that come from opioid misuse.
This innovation challenge exemplifies the commitment of FDA to confront medical epidemics, as well as provides developers with the opportunity to work with FDA directly. Some examples of medical devices that are great candidates include diagnostics, devices that prevent diversion of prescribed opioids, withdrawal treatment devices, and pain therapies that exclude opioids. Applications for this challenge will be accepted from June 1 through September 30, 2018. Those who are accepted into the challenge will have direct communication with FDA review divisions throughout the development of the proposed product. Furthermore, the devices that meet the criteria will be granted Breakthrough Device designation. The proposals that are submitted will be evaluated based on the feasibility, public health impact, and novelty of the concept. The number of proposals that will be selected will be based off of the quality of the proposals that are received. The “winning” devices chosen to participate in the challenge will be announced in November 2018. And hey, when industry and FDA come together to battle opioid use disorder, it’s a true win for America!
Prior to the selection of devices and closure of the competition, FDA will host a webinar on July 25, 2018, where developers can ask questions about the challenge. FDA remains committed to addressing the opioid crisis, and this challenge is just one component of their work to reduce the increasing numbers of opioid users around the world.