FDA budget requests include clinical software, natural language processing, real-time device data


Food and Drug Administration Commissioner Dr. Scott Gottlieb released the agency’s budget requests for fiscal 2018 Tuesday, outlining digital health plans for the year.

The budget proposed by the Trump Administration would give the FDA $5.8 billion, an increase of $673 million, and would include an additional $190 million for new user fee funding.

The requested budget would support the FDA’s continued focus on software. In its list of budget requests, Gottlieb said he wants to create a medical data enterprise, which will use “near-real-time evidence evaluation, down to the level of individual electronic health records for at least 10 million individuals.”

The idea, Gottlieb wrote, is to provide a more efficient way to develop clinical data to better inform product review and promote innovation. To accomplish this, the FDA would use natural language processing to assess data submitted to the FDA, which would “speed recognition and remediation of emerging safety concerns.”

The program would cover the full range of medical products from medical devices to biologics and cover gaps in healthcare settings not currently part of FDA surveillance.

To Gottlieb, the added real-time evidence “would generate processes that could improve the efficiency of the regulatory process, better inform patients and providers about pre- and post-market safety, [and] reduce some of the burdens that drive up the time and cost required to bring beneficial innovations to the market.”

It would also combat current data challenges “around the real-world use of products hard to collect and evaluate,” he continued.

Gottlieb also announced the FDA is launching a Center of Excellence on Digital Health, which he explained would create a new way to evaluate and recognize third-party certifiers. The center would also include a cybersecurity unit to support software-based devices.

Under Gottlieb, the FDA has been working toward speeding up the approval process for medical devices. In December, the agency announced a new voluntary approval pathway, using more modern criteria to compare devices to standards more in line with the tech being evaluated.