Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in InsideHealthPolicy, in “Gottlieb Unveils Digital Health Tools for Drug Development, Pre-Cert Model.” (Read the full version – subscription required.)

Following is an excerpt:

In a speech at Datapalooza on Thursday (April 26), FDA commissioner Scott Gottlieb announced a slew of new agency initiatives aimed at spurring use of data analytics and digital health tools in regulatory decision making and drug development. The agency also unveiled a working model for its emerging digital health software precertification program, as well as a draft guidance clarifying FDA will take a hands-off regulatory approach toward certain functions of digital devices that don’t directly affect the product’s safety and effectiveness.

The most important of these announcements, Gottlieb said, is FDA’s plan to expand “the opportunities for digital health tools to become a part of drug review, to couple these capabilities to drug delivery to form a drug delivery system.” …

Still, one industry lawyer harbors skepticism about the precertification program.

“There is no free lunch,” wrote Brad Thompson, a member of the law firm Epstein Becker & Green. “In the case of FDA’s newly developed software precertification program, the cost for industry is pretty clear. FDA wants more power. More authority. … So FDA’s proposing an exchange -- faster approvals for more FDA authority.”

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