FDA head Gottlieb promises timely device reviews post-shutdown

Despite a 35-day government shutdown that directly affected its ability to perform, the FDA said that it still plans to hold itself to established timelines for device and drug reviews for the year.

In a statement released yesterday to the House Appropriations Subcommittee, FDA Commissioner Dr. Scott Gottlieb acknowledged that during the shutdown the agency could not accept new medical product applications that required a user fee, but said that despite the slowdown, “we will work to review this bolus of drug and medical device applications in timeframes that are consistent with our user fee goals.”

“Despite the impacts of the lapse, we will endeavor to mitigate any observable impacts on our review performance goals in the coming year. We’re committed to making sure that patients continue to have access to the treatments they need, and never wavering from our gold standard for safety and effectiveness,” Gottlieb said in the prepared statement.

While the federal watchdog expects to stay on track with device and drug reviews, Gottlieb said that it is lowering its inspectional and import and field sampling goals for the year.

“We won’t be able to conduct as many inspections of food and medical product facilities, and reviews of imports, as we had originally planned. This is because we focused on the highest risk establishments during the lapse, and many other types of inspections didn’t take place. The effected programs include human and animal food, biologics, and devices,” Gottlieb said in a press release.

New goals for the year will use a risk-based approach and focus on “high-risk products, facilities that were never inspected, and firms with troubling compliance records,” according to the release.

Gottlieb said that certain policy work, especially in food and animal health programs, would also be delayed, and concluded by saying that during the immediate future he will be focusing on solidifying staff hiring and retention efforts at the federal watchdog.

Earlier this month, the FDA released draft guidance for brain-computer interface devices, an emerging novel technology that allows users direct control of devices.

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