- Combating the opioid epidemic will require advanced medical devices and sophisticated data analytics that can help detect and treat abuse, FDA officials wrote in a recent blog post.
Opioid abuse is one of the most significant health crises in the US, said Jeff Shuren, MD, JD, Director, Center for Devices and Radiological Health at the FDA, and Jonathan Jarow, MD, Chief Medical Officer, Office of Device Evaluation, Center for Devices and Radiological Health.
More than 72,000 people died from drug overdoses in 2017, the authors noted, including overdoses due to illicit drugs and prescription opioids. To combat and prevent opioid addiction, the FDA is working to find new approaches that will identify abuse and manage patients’ pain.
“The crisis of opioid overdose deaths requires innovative approaches, and the FDA is taking steps to make significant inroads against this tragedy,” Shuren and Jarow said.
“This includes efforts to help those currently addicted to opioids and taking steps to help prevent new cases of addiction while ensuring patients with true clinical need are getting thoughtful, careful and tailored approaches to manage their pain.”
The agency’s Innovation Challenge, launched in May 2018, was intended to promote the development of medical devices, including digital health technologies and diagnostic tests, that could offer new solutions to detecting addiction and treating pain.
The challenge provides incentives for medical device developers to invest in safe, effective products that have the potential to combat opioid misuse, the FDA asserted.
The FDA selected eight winners from 250 submissions from medical device developers who presented therapeutic and diagnostic devices intended to treat opioid abuse, detect overdose, and dispense medication.
The selected products won’t automatically receive funding from the FDA, but they will receive expedited review and guidance for clinical trial development plans. The FDA will hold all product development plans to its gold standard and will require all products to meet applicable standards of safety and effectiveness.
These eight products will add to the FDA’s efforts to improve pain management and control the use of opioids among patients.
Shuren and Jarow said that the agency has cleared, granted, or approved more than 200 medical devices related to the treatment or management of pain over the last few years, including ten with new or novel technologies. These devices may reduce the need to prescribe opioids to patients with acute or chronic pain.
“We believe the greatest opportunities for medical devices to help prevent opioid use disorder are devices that could help identify people likely to become addicted, devices that manage pain as an alternative to opioids or reduce the need for opioid medications,” the authors said.
“For example, the development of a diagnostic device, whether it be an in vitro diagnostic test, software or a mobile medical app, could be highly impactful in identifying those patients for whom extra caution should be exercised when prescribing opioids for acute or chronic pain.”
The FDA expects that the Innovation Challenge will help accelerate the development of medical devices that can address and combat the opioid epidemic.
“We are encouraged, inspired, and motivated by the robust interest that resulted from the Innovation Challenge,” Shuren and Jarow concluded.
“The engagement and participation from so many developers is indicative of the dire need we face for new ways to treat this disease, and that medical devices, including digital health technologies, like mobile medical apps, will play a critical role in the FDA’s all-hands-on deck approach to confronting the opioid epidemic.”