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Saturday, February 11, 2012

FDA Mobile Regulatory Fear Mongering by PhRMA

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 available" basis, that your use of the reminder service is at your own risk, and that we make no representations, warranties or covenants whatsoever with respect thereto. For greater certainty, we do not guarantee that the reminder service will be available, run error-free or uninterrupted, that we will correct all errors or deficiencies related thereto or that all messages sent by you will arrive at their intended destination on time."
ROTFL! In essence, PhRMA says it makes no promises that this app will be useful. How is this supposed to help me improve my care if PhRMA does not even care to fix errors or deficiencies? Not a very consumer-friendly attitude, I must say! BTW, I am sure the FDA did NOT require PhRMA to write that.

3 comments:

  1. Conflating non-regulated categories with regulated categories is incorrect, as you note.

    However, there are legitimate concerns. The new medical device regulations for mobile are an increase in regulatory activity in a number of areas where they did not exist before.

    Nowhere does your article address that.

    For instance, should a dosing calculator on the web be less regulated that a dosing calculator on the mobile device? Why is one a medical device and not the other?

    What about when I access a website dosing calculator on the mobile device? Then what? Does it magically become a medical device?

    Should every web-based dosing calculator now come down? Why does it take a short amount of time to get a web-based dosing calculator approved, but 6 months to get a mobile application dosing calculator approved? Does that make sense? Whose interests are served?

    Should all web dosing calculators come down until they get the same scrutiny as a mobile medical application?

    Pharma has been operating this prior way around dosing calculators for more than a decade. BTW, if a paper / slide rule dosing calculator had an error, there was no way to recall it. You can make sure a mobile app, largely, is updated automatically and doesn't startup if its not the latest version of the app (not 100%, but 99% better than what has existed over older manual dosing calculators). In these cases, the newer technology is better than the old ... but excessive regulation of the new will drive manufacturers back to the old, which is not an improvement. If excessive regulation is done on the old ... then the risk increases that product gets releated before a proper dosing calculator. Which will either reduce patient access or increase dosing errors. Is that an improvement?

    A lack of thinking can drive insanity in these positions, and shows that people HAVE NOT put the thought into these regulations.

    How do you respond to that? Have you a position on these concerns?

    I'm not defending the Washington Time / PhRMA article, BTW, which I have not read and I have no stake in.

    My concern is just apart and separate, that existing regulations are inconsistent and problematic, and fail to address the real world.

    Just because the PhRMA can't properly articulate the issues, doesn't mean the FDA regulations are good either.

    There are real world health issues unaddressed by the current situation.

    ReplyDelete
  2. Unfortunately, when the industry does not establish its own standards, that's when the FDA steps in to fill the void. For example, on the Web most calculators that I have seen were based on documented research that is cited as the source. The calculators I have seen on mobile devices do not even have that minimum of disclosure. Also, just because Web calculators are not regulated, maybe they should be! All these are programmed without any standards in place, let alone full disclosure.

    ReplyDelete
  3. Pharma has been operating this prior way around dosing calculators for more than a decade. BTW, if a paper / slide rule dosing calculator had an error, there was no way to recall it. You can make sure a mobile app, largely, is updated automatically and doesn't startup if its not the latest version of the app (not 100%, but 99% better than what has existed over older manual dosing calculators). In these cases, the newer technology is better than the old ... but excessive regulation of the new will drive manufacturers back to the old, which is not an improvement. If excessive regulation is done on the old ... then the risk increases that product gets releated before a proper dosing calculator. Which will either reduce patient access or increase dosing errors. Is that an improvement?automateandvalidate

    ReplyDelete

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