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The pharma implications of the FDA’s policy on low risk devices


On January 19th, the FDA released draft guidance about wearables dated January 20th, proving not only do they have access to a time machine, but they are totally willing to rub our noses in it. The document, which you can download here, relates to the FDA’s policy on what it deems as “low risk devices,” i.e., wearables.

Low risk devices, by the FDA’s definition, are those that, “involve claims about sustaining or offering general improvement to conditions and functions associated with a general state of health that do not make any reference to diseases or conditions.” And, more specifically, a general wellness device has,

1)  intended uses to promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions; and,

2)  intended uses to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.

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5 Key Takeaways From The FDA’s Draft Guidance on Interactive Promotional Media

This week, the FDA Quietly released it’s densely titled “Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”

You can download and read them from here.

In keeping with the tradition of most of these edicts, these guidelines are drafts and may change over time, but in reading them there are 5 key things digital marketers need to be aware of.

1. If you own it, balance it.

This may seem like an no-brainer, but it’s almost always the reason that a brand will get a warning letter. A brand is responsible for all of the content it produces, whether on an owned property like a, or within a third party site like Facebook. If a brand makes any claim whatsoever, it needs to include fair and appropriate balance. Full stop.

2. Brands are only responsible for content that they produce.

This is great news for marketers as there has been a cloud of confusion hanging over the industry for a while. Brands are most often hesitant to engage in social media because of the unknown content that may be generated by users inside of a first or third party website or social media channel. While internal requirements over how to monitor and report potential user generated adverse event communications will still determined on an individual brand level, it’s helpful to have some clarification on the responsibility brands have for content that may be produced that is outside of its control.

3. Third Party Blogger Engagements Should Become A Larger Part Of The Communication Mix.

If a brand chooses to provide bloggers or managed communities with educational or promotional content, and it has no editorial control or oversight over how that content is used, then the FDA has determined said brand is not responsible for the resulting publications and engagements. When blogs became more attractive platforms for brands to pitch messaging, this was a key tool n the communication mix, but the practice has cooled quite a bit with the uncertainty of the FDAs perspective on the matter. This should hopefully rekindle what was a very effective and trustworthy way to engage otherwise skeptical communities.

 On line 136 it states “[…] if a firm provides only financial support (e.g., though an unrestricted educational grant) and has no other control or influence on that site, then the firm is not responsible for the information on a third-party site and has no obligation to submit to the FDA. Furthermore, if a firm is merely providing promotional materials to a third-party site but does not direct the placement of the promotion within the site and has no other control or influence on that site, the firm is responsible only for the content is places there, and, thus, is responsible only for submitting to FDA promotional content that was disseminated on that site.

4. Transparency Is A Must.
If you are going to engage in a community or real time platform, brands or their representatives must clearly identify their affiliation with the product. This, like the balance guidance from point 1 should be a no-brainer, but too often its overlooked.

5. FDA Submissions Of Real Time Interactions Do Not Have To Be Submitted Prior To Deployment
Once a brand has launched, the content it produces inside of a real time channel does not have to be submitted to the FDA before it is deployed inside of a channel. So if a brand wants to respond to a message board or a Facebook post, it can do so without pre-clearing that communication. However, the FDA does require that brands periodically (monthly) submit all of the content it has deployed for review.


Creating An App-Panic

Screen Shot 2013-06-05 at 3.24.09 PM published an article detailing Apple’s ‘new’ development policy which will reject any app that includes dosing information for a medicine. Normally I wouldn’t comment on an article from another site in this much depth, but given the way headlines suddenly become ‘insights’ in this business, I thought it would be helpful to clarify a few things.

The article starts with an ominous headline “Apple is now rejecting new medical apps that include drug dosages.” Apple is not doing this across the board. One or two devs got rejected. Which by the way, happens all the time, for all kinds of reasons.  The article goes on from there, “It appears that a number of developers have struggled recently to get medical applications into the App Store.” It doesn’t say how many developers or how wide spread the problem is. And, without any kind of context as to what the app was, or any insight into it’s functionality, it’s impossible to draw any conclusion as to why it was rejected. Given the amount of apps currently in the app store that reference dosing information (mostly by manufacturers) I seriously doubt this is a widespread issue.

A simple reading of the actual rejection sent by Apple illustrates where the developer(s?) went wrong.

“We found that the Seller and/or Artist names associated with your app do not reflect the name of the manufacturer of the medicine referenced in your app or its metadata, as required by the iOS Developer Program License Agreement.

Section 1.2: 

“You” and “Your” means and refers to the person(s) or legal entity (whether the company, organization, educational institution, or governmental agency, instrumentality, or department) using the Apple Software or otherwise exercising rights under this Agreement. For the sake of clarity, You may authorize contractors to develop Applications on Your behalf, but any such Applications must be submitted under Your developer account.

We can only accept medical dosage information submitted by the medicine’s manufacturer.

If you have published these apps on behalf of a client, it would be appropriate for your client to enroll in the iOS Developer Program, then add you to their development team so you can develop an app for them to submit under their developer account.”

I actually see this as a good thing for users. First, the developer in the article clearly didn’t follow the metadata practices of Apple’s guidelines, which is a no-no. Apple has been very consistent on making sure apps are what they say they are and aren’t playing games with metadata to boost rankings. Already I’m suspicious of the developer(s?), since they seem to be unwilling to follow or correct this issue now that Apple has pointed out it’s a problem. Second, if you are publishing dosing information and aren’t doing it on behalf of the manufacturer, you may be publishing the wrong information. Since pharma has so many checks and balances on it’s content, Apple can be assured that anything with a manufacturer’s name on it would have the content verified for accuracy.

As part of gathering the info for the Mobile App Wiki, I spent quite a bit of time in the Android store. Let me tell you, it’s hard to know who’s published what. The requirements are very flimsy for publishing an Android app, and I couldn’t tell if an app was legit or not (see the Bob in IT example).  To be clear, Apple is not asking for the content to be verified, but does have some controls to ensure the veracity of content. Given the importance Apple has placed on medical content and audiences, this seems like a logical restriction to ensure quality for it’s users. So if you are developing an app for a pharma client, or doing it in house, you should be fine.