Ex-FDA staffers: Agency should exempt most mHealth apps from premarket review

The U.S. Food and Drug Administration should exempt most health and wellness apps from premarket review and start working with technology groups to define basic technical standards to spur innovation, an ex-FDA deputy commissioner and a former special assistant to FDA chief counsel opine in a Wall Street Journal column.

Such actions would provide post-market controls to ensure apps meet requirements and eliminate time wasted to get FDA permission for new products, claim Scott Gottlieb, a resident fellow at the American Enterprise Institute and former FDA deputy commissioner, and Coleen Klasmeier, head of the FDA regulatory practice at Sidley Austin, LLP. Klasmeier previously served as the special assistant to the FDA chief counsel.

Both authors currently advise medical products companies.

"There's growing frustration among entrepreneurs in Silicon Valley who are finding that the road to improving medical technology ends, not in Palo Alto, but in White Oak, Maryland--at the headquarters of the Food and Drug Administration," authors say.

Establishing standards would "enable the FDA to draw on broader expertise when it comes to these fast-moving fields. A premarket exemption could hinge on products self-certifying that they meet these specifications," they add.

Regulation of mHealth applications and devices is a hot topic among technology vendors, lawmakers and federal agencies, including the Federal Trade Commission and Federal Communications Commission. Last week, Sen. Chuck Schumer (D-N.Y.) called on the FTC to shore up data privacy regulations regarding mobile health and fitness devices, claiming device makers are sharing data without consumer permission or awareness. In addition, an FTC study in May reported mobile health and fitness applications are sharing user data with third-party vendors.

In July, FTC Commissioner Julie Brill said that she supports new laws for boosting healthcare data privacy and protection measures, but that the FTC is not mulling any new regulations.

The WSJ column notes the FDA has approved about 100 mobile apps.

"That's a fraction of what's possible," Gottlieb and Klasmeier write. "The problem isn't merely a regulatory regime ill-suited for reviewing these innovations. It's the products that are never created because mobile-tech entrepreneurs choose to direct their talents elsewhere."

They continue, saying that the FDA's regulatory "dysfunction" is part of a "30-year failure to establish a coherent approach to regulating medically related software." The agency, they add, is "making an already complex regulatory climate even harder to navigate."

To learn more:
- read the WSJ column

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