Yesterday, the Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA) which provides reauthorization for major components of the Prescription Drug User Fee Act (PDUFA) set to expire at the end of September. An important development not being widely covered, is that the reconciled bill removes language that had been added by the Senate prohibiting the Food and Drug Administration (FDA) from final rulemaking on mobile medical apps and related technologies. As a result, the FDA is now free to issue final rules providing guidance for this rapidly growing industry. FDA draft guidance on mobile medical apps was issued in July of 2011. The legislative move is seen as a positive development for the emerging digital health sector.
There are a lot of opportunities to be had creating mobilehealth apps for consumers. But there are still plenty of questions to be answered about how to build sustainable businesses. Who will pay for mhealth products? How will they be priced? At the recent Digital Health Investor Summit, co-hosted by Fenwick & West and Rock Health, the speakers addressed several key issues around revenue generation in this emerging sector.
Anne DeGheest of Healthtech Capital pointed out “apps are easy to launch, but have a high attrition rate.” Seasoned technology investor Sundeep Peechu of Felicis echoed Anne’s concerns and conveyed several mobile product axiom:
As a general matter FDA regulates all medical devices and FCC regulates devices that utilize electromagnetic spectrum - i.e. broadcast devices. So with regard to mobile health devices - sensors, applications, systems - FDA regulates any given device as a medical device while FCC regulates the device as a communications device.
Recognizing the potentially overlapping jurisdiction in digital health, in 2010 the agencies entered into a Memorandum of Understanding "to promote collaboration and ultimately to improve the efficiency of the regulatory processes applicable to broadband and wireless enabled medical devices."
Last month FCC announced its mobile body area network ("MBAN") proposal, which would allocate electromagnetic spectrum for personal medical devices. The allocated spectrum would be used to form a personal wireless network, within which data from numerous body sensors could be aggregated and transmitted in real time.
The recent Fenwick Digital Health Investor Summit included a presentation on how to design successful digital health products. Aimee Jungman, VP of Health and Wellness Innovation at frog design, discussed the four essential traits of products that gain wide adoption.
Be Real. Products need to be “familiar, personal, and culturally relevant” to patients. “Healthcare is a narrative for patients”, she explained, not a series of unrelated episodes. Successful products present data to patients in a timeline format because patients understand their health as a journey.
Tools that present data in chronological order have proven to be particularly successful in helping patients manage chronic diseases such as diabetes.
Last Friday we hosted our inaugural Digital Health Investor Summit in partnership with RockHealth at our Mountain View conference center. During the program, several key themes emerged that point to the inevitability of a more engaged and technology-driven patient. Those themes were set in the context that massive change in the healthcare delivery system is underway, irrespective of the fate of the Affordable Care Act in the Supreme Court or additional legislative initiatives.
Bob Kocher of Venrock presented compelling data showing how the U.S. healthcare industry suffers from negative productivity and is unsustainable. While other industries have significantly increased productivity over the last few decades, the misaligned incentives in our current healthcare system have allowed productivity to lag behind other sectors. The result is that savvy healthcare investors are looking to other industries for best practices.
On April 17, 2012, the U.S. Supreme Court issued a unanimous decision in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, holding that a generic drug manufacturer may file a counterclaim to force correction of an overbroad use code that encompasses unclaimed methods of using the drug at issue. In interpreting the text of 21 U.S.C. § 355(j)(5)(C)(ii)(I), the Court gave substantial weight to ensuring that the Food and Drug Administration fulfills its statutory duty to approve non-infringing generics in accord with Congressional intent. Brand manufacturers are advised to review active use codes to ensure that they reasonably reflect the scope of any claimed methods of use.
Fenwick & West's Life Sciences Group consists of more than 60 attorneys and scientists who provide a broad mix of corporate, intellectual property and litigation services to private companies, public companies, investors and research institutions.
Yesterday, the Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA) which provides reauthorization for major components of the Prescription Drug User Fee Act (PDUFA) set to expire at the end of September. An important development not being widely covered, is that the reconciled bill removes language that had been added by the Senate prohibiting the Food and Drug Administration (FDA) from final rulemaking on mobile medical apps and related technologies. As a result, the FDA is now free to issue final rules providing guidance for this rapidly growing industry. FDA draft guidance on mobile medical apps was issued in July of 2011. The legislative move is seen as a positive development for the emerging digital health sector.
