5:51 AM
Nov 19, 2018
 |  BioCentury  |  Regulation

FDA to apply light touch to biopharma apps

How FDA wants to make it easier for drug companies to give apps to patients

Concerned that regulatory uncertainty is preventing biopharma companies from developing digital tools that could help patients manage their health, FDA plans to exempt a broad range of apps and other software from premarket review.

In a proposal unveiled Nov. 19, FDA outlined a path that treats software as promotional material if a company doesn’t plan to claim it as necessary for the safe and effective use of a product (see BioCentury Extra, Nov. 19). Such material must be submitted to FDA at the time it is distributed, but in most cases does not require approval or clearance.

The proposal represents FDA’s first attempt to integrate digital health, which has been handled by the Center for Devices and Radiological Health, into drugs and biologics reviews.

The goal, FDA Commissioner Scott Gottlieb told BioCentury, is to clear regulatory ambiguity preventing biopharma companies from embracing mobile and other digital technologies. “The technology is ubiquitous, and I think this industry’s been slow to leverage it in large measure because of the regulatory uncertainty.”

Low-hanging fruit, Gottlieb said, includes digital tools to help improve adherence to therapies, track and communicate symptoms to physicians, and collect data that physicians can use to make treatment decisions such as dose adjustments.

“There is a lot of interest in the industry in developing these tools, and I think that these tools can help promote better healthcare,” he said. “They can promote compliance, promote collection of information that can be used to inform and engage with physicians, and promote the collection of real-world data that can be used to help inform follow-on drug development.”

The framework, which covers “prescription drug use-related software” (PDURS), is part of a larger initiative to create pathways that facilitate digital health products, ranging from wearable devices to app-enabled over-the-counter (OTC) purchases.

If it succeeds, FDA’s initiative could create pathways for drug companies to leverage digital tools to transition themselves from purveyors of pills and vials with little direct contact with patients into organizations that provide health solutions and actively help patients manage and improve their health. BioCentury argued in its 2018 Back to School essay that this transition is an essential element of emerging biopharma business models (see "A pathway to Biopharma 3.0").

Creating regulatory clarity is necessary but not sufficient to turn pharma companies into powerhouse app developers. A handful of drug companies has experimented with the kinds of apps Gottlieb envisions, and patient response has been underwhelming (see “FDA May Be the Easy Part for Pharmas With Apps”).

Sidebar: FDA may be the easy part for pharmas with apps

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