The Burrill Report

A last-minute amendment to legislation passed by the U.S. Senate to reauthorize the Prescription Drug User Fee Act has introduced a potential hurdle to the FDA finalizing its guidance on mobile health apps, clouding the near-term prospects for app developers seeking clarity on the agency's regulatory approach.

The amendment to the Senate's Food and Drug Administration Safety and Innovation Act, proposed by Senators Michael Bennet, D-Colorado, and Orrin Hatch, R-Utah, would keep the FDA from finalizing a document outlining its approach to reviewing mobile medical apps for up to 18 months as the U.S. Department of Health and Human Services convenes a group of outside experts to draw up recommendations for an appropriate, risk-based regulatory framework for medical device regulation and health information technology software.

The FDA issued draft guidance on mobile medical applications in July 2011, at which time it said a small subset of mobile medical apps that could impact the performance or functionality of currently regulated medical devices would require FDA oversight. Since then, developers of mobile medical apps that could potentially fall into that category have eagerly awaited final guidance.

The roadblock to issuing final guidance on mobile medical apps is part of the Senate bill, but not part of a similar bill passed by the House of Representatives, so its fate will be tied to the reconciliation of the bills. In the hope that it doesn’t survive the reconciliation, the mHealth Regulatory Coalition raised its opposition to the amendment in a letter to key senators.

“The proposed amendment will hinder innovation and job creation in the rapidly growing mHealth ecosystem because it will extend the period of regulatory confusion and lead to over-regulation during the moratorium,” says the coalition, which members include companies such as AT&T, Qualcomm, and WellDoc.

“While we recognize the need to enhance the draft guidance and support mechanisms for public input, we seek to continue dialogue and engagement on these issues directly with the agency, rather than through legislation at this time,” the group says.

The Application Developers Alliance, a group of app developers, entrepreneurs and investors, also weighed in with a letter directed to the senators, calling for a finalization of the guidance sooner, rather than later.

“App developers agree that medical mobile app regulation should be comprehensive and risk-based, and should be coordinated among all the relevant agencies,” wrote Jon Potter, president of the Alliance. “However, we believe that this long-term strategic process should proceed in tandem with FDA’s ongoing work, which has the potential to provide additional clarity–sooner–around the current regulatory environment for medical mobile apps.”

At least one group, Health IT Now, a coalition of insurers, technology, and disease-focused associations, has expressed support for a more deliberative approach that would take time to further develop the FDA guidance on mobile apps, according to FDA Week. But it also shares a sense of nervousness about the pace of regulation. “Innovation is key to the future. If heavy handed regulations are put in place, it could risk stifling progress,” the group wrote on its weblog May 30.

“We encourage the conference committee to take a stronger approach and ensure the FDA consults with other federal agencies and convenes a federal advisory committee of external stakeholders to ensure all views are considered in determining the most appropriate regulatory framework for innovative technologies,” says Joel White, executive director of the Health IT Now coalition.

Now that the Food and Drug Administration Safety and Innovation Act has sailed through both the Senate and the House, the bills will be reconciled. Whether the clause delaying the release of FDA’s guidance on mobile medical apps will survive in the final bill sent to President Barack Obama remains unclear.



June 01, 2012
http://www.burrillreport.com/article-medical_app_developers_sweat_potential_delay.html