I have gotten used to a degree of vacillation from the FDA regarding various lab regulatory issues. A recent chapter in this drama was the agency's ambiguity about lab tests originally called IVDMIAs and subsequently referred to as laboratory developed tests (LDTs). Now comes news that the agency may, or may not, regulate medical smartphone/tablet (i.e., mobile) apps and the use of social media by pharmaceutical companies (see: FDA Reportedly Gearing Up to Regulate Apps). Below is an excerpt from the article:
From a no less august source than American Medical News comes a report that the FDA is considering the regulation of medical apps. See “FDA Signals it Will Regulate Medical Apps“. The article quotes a source who relayed that at a town hall meeting held in March, the Center for Devices and Radiological Health (CDRH) “plans to issue guidance on mobile medical applications later this year.”....There is no direct quote from anyone at FDA on this, but the report is certainly a surprise, to say the least, to anyone who has followed the agency’s tortuous pathway to the development of some guidance – any guidance – on the Internet and social media. In October, 1996, the agency held its first public meeting on the regulation of the Internet and the Promotion of Medical Products....In November 2009, they did the same 1996 meeting over again, only this time throwing in social media and targeting the end of 2010 for the issuance of a draft guidance. It didn’t happen. Then the end of the first quarter for a guidance. It didn’t happen. Now, they have announced the intention for a study on how the Internet might actually differ from print and broadcast to look at DTC, the Internet and Fair Balance. Given this track record and a time frame that is well into its second decade, you may understandably want to take the news that the agency is going to deal with one of the fastest paced frontiers in new media with a guidance by the end of the year with a grain of salt. In fact, here is a whole shaker for you. Timing aside, there is another worrisome aspect to this news. First, the development of apps has been one of the most innovative developments among new media. One only has to go to an App Store to see that. And one only has to download a few to know that there can be vast differences in quality....On the other hand, when it is coming from an agency that has been slow to assess, analyze and respond to emerging media in the past, the rush to push out a guidance on this topic, if true, might be overly ambitious.
I have paid considerable attention to smartphones and smartphone apps in this blog (see: Smartphones as the New PCs; Connecting to Healthcare Professionals and Consumers; New Definition for "Apps": The Smartphone Market for Medical Software; Big Pharma Develops Smartphone Apps to Achieve Multiple Goals). There is no question in my mind that Big Pharma will be moving quickly from TV and print-based direct-to-consumer (DTC) advertising to social media marketing (see: Social pharma faces: Craig DeLarge). This coincides with the decreasing emphasis on physician office calls by pharmaceutical reps (i.e., detailing) (see: E-Sampling: Another Blow to the Future of Pharma Sales Reps). Hospitals will not be too far behind (see: Why and How Hospitals Should Market Themselves to Consumers on the Web). Moreover, smartphones with a set of medically-oriented apps will be in the pockets of nearly all physicians very soon (see: Major IT Prediction for 2011 -- Apps Go Corporate).
Are medical apps and the use of social media appropriate regulatory targets for the FDA at this time? The answer to this question is clear and can be extracted from the last sentence of the article above: ...[W]hen [such an initiative] is coming from an agency that has been slow to assess, analyze and respond to emerging media in the past, the rush to push out a guidance on this topic, if true, might be overly ambitious. Even keen observers of the web scene and mobile apps have difficulty in keeping abreast and understanding new developments in these fields. The likelihood that a ponderous federal agency could succeed in such an endeavor is unlikely.
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