Ambiguity persists in FDA regulation of digital combination products

While regulators have worked for years to dispel ambiguities surrounding their approach to Software as a Medical Device and digital combination products, substantial gray areas remain. During a panel discussion at the very first BrightInsight Ecosystem Event, S. Prasad Peri, the Senior Director of Global Regulatory Affairs for Respiratory and Devices at Teva Pharmaceuticals, shared his insights and cut through the noise around the regulation of digital therapeutics. The content below includes excerpts from remarks Peri made on-stage during the session, How to Thrive in Today’s Complex Digital Health Regulatory Environment.

“In terms of the FDA regulations, there is still a lot of gray area,” Peri said. “I joined Teva Pharmaceuticals 3.5 years ago just after we embarked on this journey to get clearance for the ProAir Digithaler, which is the first fully integrated inhaler that captures how a patient is doing in terms of peak airflow. It is a rescue inhaler for asthma treatment.”

Peri said that getting the connected health device and its companion software cleared took many years.

“When I joined Teva in December 2015,” Peri said, “the company had already had several meetings with the FDA. The FDA’s regulation of mobile apps and about connected digital devices was not very clear, and it took us a lot of time and a lot of meetings with them to understand them. In the end, the final product was approved in December 2018. It took us about 3 years before we finally got approved… And remember, during that same period we were talking to them, from 2015 to 2018, the FDA published many new software-related guidance documents.”

While the time it takes to get through the FDA clearance processes has been widely discussed, Peri also pointed out that the necessary internal discussions to prepare for the initial meetings with the FDA are also time-intensive. They need to be accounted for as part of this years-long process too. Peri said the internal discussions were even more time-intensive than the ones with the FDA.

“Yes, it took us about three years before we finally got approved, but part of that is related to your internal process: how you develop it, how you regulate resources, and how you secure concurrence from all of your stakeholders, in terms of what your offering really is,” Peri explained. “Very different opinions will come out if you talk to a physician versus a commercial person versus a regulatory person as to what should be in the label. Getting alignment internally about what the product offering will be is key.”

Teva’s ProAir Digithaler is now available through a small number of “Early Experience” programs that the company has setup with a limited number of healthcare systems to gather real-world experience data. Teva has plans for a national rollout in 2020.

The rapid pace of digital health innovation has driven the FDA to articulate additional regulatory clarity for medical app developers and manufacturers of combination products. The FDA’s actions in recent years, however, suggest regulations for software products will evolve at an increasing pace, adding complexity to pharmaceutical and medtech companies’ already demanding regulatory responsibilities.

Pioneering biopharma and medtech companies like Teva have spent years meeting and educating regulators about digital health. In the process, they have managed to emerge from digital health’s regulatory ambiguity and get their products to market.

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