In a blog post provocatively titled "An App for That, But For How Much Longer?" (here), PhRMA's Kate Connors agreed with a Washington Times op-ed piece that suggested the FDA will soon require apps such as medication prescription renewal reminders and blood glucose level tracking functions to be regulated as medical devices. You can read the op-ed in this threaded archive: "How safe is that app? Should pharma apps be registered as medical devices?".
The op-ed author, Joel White, executive director of the Health IT Now Coalition, "suggests that this effort would lead to increased costs as well as constraints on user access to these apps, which 'may cause developers to move on to other, less burdensome endeavors.' In the end, this could hinder the way that patients can actively improve their own care," said Conners.
Before I get to destroying the case made by Connors and White, I should point out how these two people are related. White is the president of JC White Consulting, a registered lobbying firm (see here) retained by the Health IT Now Coalition and PhRMA, among others (see here). In her blog post, Connors said "A few days ago, I missed an op-ed in the Washington Times that I just came across today – and I’m glad I did." Joel, you should have DM'd Kate! Whatever! It's nice that White gets paid to write this "independent" op-ed piece that PhRMA can cite as if it were independent! Guys! Wake up! It's the era of transparency! Unfortunately, you can fool some -- maybe even most -- of the people all of the time and that is what keeps PhRMA in business.
Anyway, back to "FDA Mobile Regulatory Fear Mongering." I say "fear mongering" because it can't be true that White and Connors failed to read FDA's July guidance in which it stated that the agency does NOT consider the following types of apps to be mobile medical apps for purposes of the guidance:
"Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition. Examples of these apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness."PhRMA/White do not quote FDA because to do so -- as I just did -- would kill the argument that FDA mobile guideline/regulations will stymie pharma from developing apps and will "hinder the way that patients can actively improve their own care." You should also read "No, the FDA is not assaulting mobile technology, Washington Times editorial misguided" published by iMedicalApps.
Meanwhile, there are medical apps being created by pharma that SHOULD be regulated by the FDA, IMHO. These are "calculator" apps designed to be used by physicians during diagnoses. One such app had to be "recalled" because of a bug that generated incorrect results. Unfortunately, thousands of physicians may not have heard of the "recall," which merely removed the app from app stores, not from the phones of physicians who downloaded the app. These physicians may still be using the buggy app. See "The Problem with Unregulated 'Calculator' Apps for Physicians: Buggy Software!"
P.S. Connors pointed out that PhRMA has its own medication reminder app for patients: "In fact, we at PhRMA have helped support the Script Your Future campaign, which itself includes medication reminders as a tool."
Just for fun, I signed up to receive reminders. I was, however, somewhat put off by the long legal disclaimer, which said, in part:
"You acknowledge and agree that we provide the reminder service and access to the reminder service as an "as is" and an "as read more..
Friday, 15 June 2012
Fda Mobile Regulatory Fear Mongering-Phrma-FDA
Saturday, 21 April 2012
Social Media Marketing-Panel Discussions-Pharma Industry-Mobile Search
Didn’t attend DTC Perspectives’ big DTC National conference in Boston this year?
No worries. I spent three days there last week (my first time). Several of us tweeted the highlights using hashtag #DTCN2011, so you can view all the tweets by searching the hashtag on Twitter. You can still view the conference agenda online.
I tweeted. A lot. But one can only say so much in 140 characters or less. So beyond the tweets, I wanted to provide a more in-depth review. Below is the first in a series of blog posts with key observations by day:
DTC National: Day One
Day one of the conference kicked off with a small pre-conference workshop in the morning. Pharma folks gathered for a series of small panel discussions, moderated by Bob Ehrlich, on the following topics:
- Optimizing The Brand Web Site
- The Use of Search
- Advertising on the Web/mobile
- Direct Mail and Direct Response
I was surprised there wasn’t a social media panel, but perhaps everyone’s sick of talking about that for now. How much more can we say about FDA still not delivering guidance anyway?
The panels were lively and informative, focusing in depth on these areas more than – as I learned in later days – the main conference itself. The audience asked questions and there were healthy discussions. I always like the smaller group settings better at these things. A few highlights:
• I laughed during the “Optimizing the Brand Web Site” session when conference chairman and moderator Bob Ehrlich asked the panel to stop talking about mobile (because there was a separate upcoming panel on mobile). What was left unsaid was that the Web and mobile are so intertwined that the two cannot be separated. I saw a tweet last week rom the iStrategy conference (source unknown) that over 50% of Web activity occurs on a mobile device! But wait … I’m not supposed to be talking about mobile here … so moving on …
• I spoke on the panel on which I thought was going to be about online and mobile media – “Advertising on the Web/mobile” - but which turned out to be all about mobile. We talked about optimizing sites and the plethora of healthcare apps available today. And we all agreed that there is a lot more for pharma to be doing in this channel. It struck me, too, that there’s so much more to mobile than just apps or mobile sites … there’s mobile media, mobile search, and optimizing emails for mobile viewing. At what point will pharma pay attention to these on a regular basis? I fear we’re a long ways off.
• I particularly enjoyed the “Use of Search” panel where Yahoo!, Google, and Bing representatives (among others) all gathered to discuss character limitations and potential implications of coming DDMAC guidance. To their credit, they were certainly mindful of the issues the industry faces. And the question was asked … who says there have to be character limitations? Not FDA .... Google, Yahoo! and Bing decide! I was pleased to see so many search reps at the conference and their industry’s openness to working with the pharma industry's – shall we call them – "special circumstances."
• The multicultural panel was hosted by several multicultural marketing agencies who made the very valid case for pharma to be reaching out to minorities, especially in relevant conditions such as diabetes and hypertension that disproportionally affect African-Americans and Hispanics. I have the hunch multicultural marketing is to pharma now as social media marketing was to pharma a few years ago: Marketers have an inkling they need to be doing it, but they don’t know much about it so they avoid it altogether.
While Bob’s panel moderation style came across a bit condescending - as if he didn’t believe people went on the Web or used mobile phones to do anything but talk - it also provided healthy perspective. We in the marketing and digital worlds drink our own Kool-Aid every day. Bob’s right – some of the consumers we’re trying to reach are read more..