New congressional action could seriously delay the Food and Drug Administration's mobile medical app guidance.
Sen. Tom Harkin (D-Iowa) has proposed a new bill (S.3187) that, among other things, would require the FDA to conduct a full-scale report to Congress on its plans for regulating mobile medical apps. And it wouldn't be allowed to finalized its proposed mobile apps guidance until it received the Senate's sign off.
Harkin wants the FDA to lay out its entire "proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to medical device regulation and health information technology software, including mobile applications"--no small feat in the regulatory world.
Even more time-consuming, the FDA would have to convene a working group of "external stakeholders and experts to provide appropriate input on the strategy and recommendations required for the report." The bill gives the FDA 18 months to finalize the report, and you can bet the process could easily take every day of that, and more.
Bradley Thompson, FDA expert with Washington, D.C.-based law firm Epstein Becker Green hopes it won't come to that. He and other proponents are "actively talking with Senate staff" about the FDA's timeline, and pushing for the guidance "not to be held up," he tells FierceMobileHealthcare. With the pace the market is growing and changing, he says, healthcare providers, app developers and others need clarity now on what the FDA expects, and what the regulatory process will be--not in late 2013.
It will be interesting to see if it turns into a partisan battle on Capitol Hill. Remember a few months ago, we told you about a Republican group pressuring FDA to move its guidance along and help keep the mHealth market growing.