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An innovation challenge launched by the U.S. Food and Drug Administration provides an appealing incentive to developers: increased interaction with the agency during product development, according to an FDA consultant.
The FDA issued the innovation challenge, which has a September deadline and encourages developers to create pain management devices as a way to address the ongoing opioid crisis in the United States. FDA consultant Matthew Weinberg believes the FDA's incentive offering developers the opportunity to work directly with the agency to accelerate product development is a key aspect of the challenge and has the potential to influence people and organizations to participate and speed up the time it takes to get a product to market. Weinberg serves as CEO of The Weinberg Group, a regulatory and compliance services company.
"I think a challenge like this potentially provides incentive for organizations that might be on the edge of choosing between this and another product, or it might incentivize an inventor or someone who's got an idea to say 'Aha, there's an enhanced path forward for me that may make it easier for me to find success with this product,'" Weinberg said.
FDA support offered as incentive
According to FDA spokesman Michael Felberbaum, developers accepted into the challenge will receive enhanced interactions with FDA review divisions during the development and evaluation of the proposed product and Breakthrough Device designation will be granted to devices that meet the statutory criteria.
"This challenge will provide those companies that are selected by the FDA under this new program with the opportunity to work closely with the agency to accelerate the development and review of their innovative products," Felberbaum said. "The goal is to provide additional incentives for product developers to invest in products that can address aspects of the addiction crisis, and advance the development of promising technologies." The FDA does not traditionally take on the role of a consultative organization and it isn't something the organization could do regularly, Weinberg said. But he said the organization is taking a step outside their normal arena to address the opioid crisis.
Michael WeinbergCEO, The Weinberg Group
"One of the realities is the FDA is not a consultative organization," Weinberg said. "It's not the way they're designed, it's not their job, it's not their role as a regulator. Here they are, because of the national crisis, stepping out of the normal box and saying, 'We're going to do something extraordinary in order to facilitate improvement in the national sphere.'"
Weinberg said he thinks a large number of organizations and entrepreneurs in the drug and device development sphere would "welcome more interaction with the agency," something this challenge provides.
"The FDA can appear to small firms to be impenetrable," he said. "To incentivize people and say, 'We're going to work with you' will help people who might otherwise be hesitant and might also speed up time to market."
FDA hopes incentive spurs product development
The FDA is encouraging developers to submit proposals for pain management devices and digital health technologies at any stage of development that could detect, treat and prevent addiction and treat pain. Potential products include diagnostics identifying patients at a heightened risk for addiction and pain treatments, eliminating the need for opioid medications, according to an FDA news release.
The challenge also calls for pain management devices and products that focus on treating opioid use disorder or symptoms of opioid withdrawal and technology that could prevent a patient prescribed an opioid from giving the drug to another person.
Felberbaum said the FDA is open to the submission of any type of medical device that prevents or treats opioid use disorder and expects the organization will see a range of applications for diagnostic devices, mobile medical apps and therapeutic medical devices submitted in response to the challenge.
"There are a variety of neuromodulating medical devices that treat pain and reduce the symptoms of opioid withdrawal," Felberbaum said. "However, there are still many opportunities to expand device technology in this area, bring new products to market and meet this urgent public health need. There is a critical need for innovative medical therapies that safely and effectively treat pain and are a viable alternative to prescription opioids."
Hoping for challenge success
The FDA has issued challenges in the past and Felberbaum said this new effort builds on the success of previous work, such as the 2012 challenge that led to multiple new approaches for treating end-stage renal disease, to take a "collaborative approach to promoting medical device innovation and safety."
The FDA will accept submissions for pain management devices, which will be evaluated for product feasibility, novelty of the concept and potential public health impact by a team from the FDA's Center for Devices and Radiological Health, until Sept. 30 and plans to announce selected recipients later this year.
FDA Commissioner Scott Gottlieb said in the news release that "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," Gottlieb said in the release.