The Food and Drug Administration launched a competition to the public to support the development of an app that can help reduce deaths associated with prescription opioid and heroin overdose.
According to the announcement, the primary goal of the Competition is to reduce death from opioid overdoses by expanding access to naloxone, in support of the Federal Government’s mission to protect and advance public health. The secondary goals of the Competition are:
- To increase public awareness about naloxone and its role in reducing death from opioid overdoses; and
- To promote open government and citizen participation to improve innovation in the Federal Government.
The Competition encourages computer programmers, public health advocates, clinical researchers, entrepreneurs, and innovators from all disciplines to create teams focused on the development of innovative strategies to combat the rising epidemic of opioid overdose. Specifically, the Competition invites submissions for an app that increases the likelihood of timely naloxone administration by connecting opioid users experiencing an overdose with nearby naloxone carriers. FDA is most interested in concepts that are readily scalable, free or low-cost to the end-user, and take advantage of existing systems for naloxone distribution and use. FDA’s expectation is that any app developed through the Competition will be used with FDA-approved naloxone products.
Interested parties may register for the Competition at http://www.Challenge.gov; participants are highly encouraged to register as teams, but individual applicants will also be accepted. The Competition will be conducted in two phases.
- Phase 1 will consist of a code-a-thon hosted at the FDA campus in Silver Spring, Maryland, for registered entrants to develop their concepts and initial prototypes for an app that alerts carriers of naloxone to a nearby opioid overdose. Entrants are encouraged, but not required, to participate in the code-a-thon. The code-a-thon will occur on October 19 and October 20, 2016. All code developed through the code-a-thon will be made open-source and publicly accessible on the GitHub platform, a Web-based code repository. The code-a-thon event space is limited to the first 50 individuals who indicate interest in onsite participation during the registration process (see Section IV). There will be a virtual component to the code-a-thon for the first 100 individuals who indicate interest in remote participation during the registration process.
- In Phase 2, all registered entrants will refine their concepts and develop a functional prototype, a video of which will be submitted on http://www.YouTube.com by the submission deadline. The video will be accompanied by a short summary of the prototype, as detailed in this document, which will be submitted on http://www.Challenge.gov.
Federal Agency subject matter experts will provide background and technical information to entrants on topics including, but not limited to, the opioid epidemic, uses of approved formulations of naloxone, and regulatory science considerations. During all phases of app development, all entrants should consider strategies to minimize legal risk and maximize regulatory compliance, including for the developer and the end-user. To ensure adequate consideration of potential liability, privacy, and regulatory concerns, FDA strongly encourages all entrants to obtain independent legal counsel.
FDA is sponsoring the Competition and will be providing entrants with technical expertise from the National Institute on Drug Abuse (NIDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA). Specifically, NIDA and SAMHSA will each provide one judge with experience in relevant fields including drug use and misuse, clinical trial design, development of mobile medical applications, and public health. Additionally, NIDA and SAMHSA will provide information to Competition entrants at the code-a-thon on key issues, including:
- Patterns of opioid use and misuse
- Characteristics of populations at risk of opioid overdose
- Data collection and evaluation considerations