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Gottlieb Tackles the FDA’s Innovation Reputation Problem


Pharmaceutical Executive

The agency’s new commissioner unveiled new digital health pilot programs to help navigate regulatory requirements.

When it comes to digital health, two of the biggest complaints tend to be the lack of clear FDA regulations and the speed at which the FDA approves digital technology compared to the speed of innovation.

Those complaints have not gone completely unanswered, as the agency has started to slowly roll out new digital health initiatives-something Pharm Execreported on in June.

But still, it’s not entirely what the industry has been craving.

Scott Gottlieb, the new FDA commissioner, however, is rolling up his sleeves and taking a deep dive into the digital health issue. In a recent post on the FDA’s official blog, Gottlieb admitted that the FDA doesn’t have the best reputation when it comes to digital health or innovation.

As part of a solution to the problem, he announced the formal launch of its Pre-Cert for Software Pilot Program. Gottlieb also mentioned that the FDA’s Center for Devices and Radiological Health is publishing its Digital Health Innovation Action Plan to provide details and timelines for its integrated approach to digital health technology and the implementation of the 21st Century Cures Act.

“FDA’s traditional approach to medical devices is not well suited to these products,” he wrote. “We need to make sure our approach to innovative products with continual updates and upgrades is efficient and that it fosters, not impedes, innovation. Recognizing this, and understanding that the potential of digital health is nothing short of revolutionary, we must work toward establishing an appropriate approach that’s closely tailored to this new category of products. We need a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical promise, the unique user interface, and industry’s compressed commercial cycle of new product introductions.”

Under this new pilot program, the FDA will concentrate more on the technology developer, instead of just the device, as they do with traditional medical devices.

“The goal of our new approach is for FDA to, after reviewing systems for software design, validation, and maintenance, determine whether the company meets the necessary quality standards and pre-certify the company,” Gottlieb wrote. “Pre-certified companies could submit less information to us than is currently required before marketing a new digital health tool. In some cases, pre-certified companies could not submit a premarket submission at all. In those cases, the pre-certified company could launch a new product and immediately begin post-market data collection.”

In the blog post, Gottlieb outlined what the agency will be looking for when it comes to selecting companies to be included in the pilot program and how those who are interested can apply.

Results from the program should be available in January 2018.

Gottlieb seems to be committed to moving the agency forward when it comes to digital health, and acknowledges the important part technology can play in the future of healthcare.

“But the most powerful feature of this market may not be one revolutionary app but rather a combination of apps that provides consumers and providers with the information they need,” he wrote. “This can help people better manage their chronic diseases, which could result in less trips to the doctor for checkups, or better awareness of illness, like prompts to a parent with a sick child on when they need to see a provider.”

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