Drugmakers have been edging into the mobile app world, but to some companies, it still seems fraught with peril. Well, pharma, you can relax on at least one score: The FDA isn't interested in regulating your apps--most of them at least.
As long as you aren't planning to offer ECG apps for your patients on anticoagulants, or blood-glucose meters along with your diet-and-exercise apps for diabetes patients, you won't have to ask the FDA to review them. Carb-counting is safe. So are exercise logs. And so are those take-your-pills reminders that everyone hopes will keep patients on their meds.
In essence, the FDA wants only to dig into apps that act like medical devices. "We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly," said the FDA's Dr. Jeffrey Shuren, who runs the agency's Center for Devices and Radiological Health (as quoted by Reuters). As he pointed out, "It's not about the platform. It's about the functionality. An ECG is an ECG."
The next question is whether the FDA's new guidance will set drugmakers at ease enough to develop a new round of mobile apps. Boehringer Ingelheim, Sanofi ($SNY), Eli Lilly ($LLY) and Novartis ($NVS) have been particularly active in the area, but there's plenty of room for more. Beyond the mix of reference works for doctors, games for patients, clinical-trial connectors for researchers, and education apps for all three are opportunities to become part of patients' daily care and doctors' daily practice.
Indeed, Sanofi CEO Christopher Viehbacher sees his company's future as a more integrated healthcare company, with drugs supplemented by digital devices, diagnostics, apps, and patient services. "I believe in the healthcare approach," Viehbacher said earlier this year. "The marriage of digital technologies with therapeutics is a phenomenon that is only going to grow."
- see the Reuters story
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