I'm using the word "new" in the headline of this blog post in the technical sense that FDA uses for promoting drugs, namely within the past six months, because the new guidance was actually published in February of this year. I didn't notice it at the time, so apologies for the late notice.
I'm blogging about it anyway because the topic is of interest in general (namely what apps are subject to FDA enforcement focus vs. enforcement discretion), and because the update itself is interesting to FDA process geeks like me.
Here's a quick timeline for the uninitiated:
In 2011, FDA released its first draft guidance* about how it would apply its regulatory authority to the realm of mobile apps. Here's my take at the time.
Industry (and Congress) reacted as if FDA were suddenly imposing a new set of regulations on a vibrant and rapidly evolving technology, despite the fact that FDA had been regulating apps for years.** As a result, there was significant pressure exerted on FDA to finalize its guidance.
In 2013, FDA released a finalized version of the guidance. Here's my take at the time.
In 2014, FDA released a new draft guidance about Medical Device Data Systems. As I noted at the time, this guidance significantly downgraded the regulatory status of MDDS, essentially shifting the entire category of apps from the group of apps where FDA would focus its regulatory attention to the group of apps where FDA would exercise "regulatory discretion," i.e., choose not to enforce regulatory requirements.
In addition, this guidance also by extension altered the finalized mobile apps guidance, and though I agreed (and continue to agree) with this decision, I mentioned that this created an odd situation for those relying on FDA's guidance. We had a new draft guidance about MDDS, which was making revisions to the mobile apps guidance, without any indication in the mobile apps guidance itself that it was undergoing a revision.
Instead, FDA is maintaining a separate, real-time listing of apps that it is updating as individual classification decisions are being made.
I applaud this innovation. I think it helps industry tremendously to have FDA maintaining this consolidated listing of decisions, especially because (as the MDDS guidance itself shows), FDA is willing to reconsider these decisions as the technology evolves.
The wrinkle is that you have to keep on top of these process issues closely to understand them. Otherwise, you'd find yourself going to the guidance, which was always kept in its final status, and assume that you were reading FDA's current thinking about a topic without realizing that FDA had released other, newer guidance that contradicted the position from the "final" guidance.
Well, as of February of this year, that discrepancy has been resolved. FDA finalized the MDDS guidance, and at the same time (apparently), released an updated final mobile apps guidance.
In reading through the new version of the final guidance, it does not appear any significant changes have been made to the FDA's classification scheme for mobile apps, or any additional reclassifications have been introduced; however, if anyone finds such changes, please point them out in the comments.
* I'm posting this (and other) guidance on my own site. My sharing these documents should not be construed as endorsing the views set forth in it, nor should it be taken as a sign that these views represent FDA's current position. This link is merely being provided for historical research purposes and use by others who would like to see how FDA's position has evolved.
**According to both FDA and press, FDA has been clearing (i.e., regulating and accepting apps as medical devices) since at least 1997.
Showing posts with label mobile. Show all posts
Showing posts with label mobile. Show all posts
FDA Still Not Ready to Tackle Mobile Promotion
Updated to correct error of publishing an incomplete sentence and a misspelling.
On Thursday, FDA held a webinar about its recent social media guidances. Despite technical difficulties that prevented many (including me) from attending the webinar, FDA did field questions from some of the attendees, and late on Friday afternoon, they posted that Q&A along with the slides from the presentation portion of the event.
In reviewing the Q&A about the space-limited presentation of risk information guidance, one exchange stood out:
While the guidance itself clearly specifies that its scope is limited to social media platforms and paid search with character-count limitations*, it is disappointing to see the exchange. Perhaps it was the nature of the question that resulted in this specific answer, but one would certainly like to know how widely applicable the principles from this guidance are to mobile devices in particular because many of the issues that apply to presentation of risk information in limited character counts also apply to presentation in limited space.
In addition, though, this Q&A further emphasizes one of my concerns about the guidance. It concerns itself solely with the content of each individual Tweet** and completely ignores the surrounding context and nature of Twitter interactions. That larger context is part of what I have begun fleshing out via a previous post about a different Twitter proposal. There is far more going on when a person views a Tweet than just the 140 characters in the Tweet itself, and I believe that FDA is inappropriately limiting both its evaluation of what can make a Tweet compliant (or non-compliant) and its understanding of the actual uses of Twitter and other social media platforms.
Social media hosts public conversations, and just as you would not expect every single sentence uttered to include the complete conversation, you should not necessarily expect every Tweet to include everything needed to achieve a compliant communication.
Further adding to the difficulty is that just as FDA is finally providing guidance to address some of the most pressing issues in social media, we're seeing massive shifts in the consumption of social media itself with an increasing amount of social media interaction happening via mobile devices. So much so that some people have taken to referring to the combined fields as "somo" or "moso" to underline how much the line between social media and mobile has blurred.
* "This draft guidance also does not address responsive web design or other technology-specific layout features that may result in product promotion presentations that differ depending on the technology used to view them (e.g., desktop computer monitors, mobile devices, tablets)." (page 2)
** It's worth noting that people have been referring to this guidance informally as the Twitter guidance, and by refusing to discuss how to apply its principles beyond Twitter and Google, that moniker seems even more appropriate. For years, FDA declaimed its intention to not provide guidance that was limited to any specific platform(s) because of how rapidly the platforms evolved, and yet, ironically, it seems as if FDA is now intentionally doing exactly that.
On Thursday, FDA held a webinar about its recent social media guidances. Despite technical difficulties that prevented many (including me) from attending the webinar, FDA did field questions from some of the attendees, and late on Friday afternoon, they posted that Q&A along with the slides from the presentation portion of the event.
In reviewing the Q&A about the space-limited presentation of risk information guidance, one exchange stood out:
Q1. Does this draft guidance apply to space limitations imposed by mobile devices?A1: This draft guidance does not address technology-specific layout features that may result in product promotion presentations that differ depending on the technology used to view them (e.g., mobile devices, desktop computer monitors, and tablets). The scope of this draft guidance is specific to Internet/social media platforms that impose character space limitations.
While the guidance itself clearly specifies that its scope is limited to social media platforms and paid search with character-count limitations*, it is disappointing to see the exchange. Perhaps it was the nature of the question that resulted in this specific answer, but one would certainly like to know how widely applicable the principles from this guidance are to mobile devices in particular because many of the issues that apply to presentation of risk information in limited character counts also apply to presentation in limited space.
In addition, though, this Q&A further emphasizes one of my concerns about the guidance. It concerns itself solely with the content of each individual Tweet** and completely ignores the surrounding context and nature of Twitter interactions. That larger context is part of what I have begun fleshing out via a previous post about a different Twitter proposal. There is far more going on when a person views a Tweet than just the 140 characters in the Tweet itself, and I believe that FDA is inappropriately limiting both its evaluation of what can make a Tweet compliant (or non-compliant) and its understanding of the actual uses of Twitter and other social media platforms.
Social media hosts public conversations, and just as you would not expect every single sentence uttered to include the complete conversation, you should not necessarily expect every Tweet to include everything needed to achieve a compliant communication.
Further adding to the difficulty is that just as FDA is finally providing guidance to address some of the most pressing issues in social media, we're seeing massive shifts in the consumption of social media itself with an increasing amount of social media interaction happening via mobile devices. So much so that some people have taken to referring to the combined fields as "somo" or "moso" to underline how much the line between social media and mobile has blurred.
* "This draft guidance also does not address responsive web design or other technology-specific layout features that may result in product promotion presentations that differ depending on the technology used to view them (e.g., desktop computer monitors, mobile devices, tablets)." (page 2)
** It's worth noting that people have been referring to this guidance informally as the Twitter guidance, and by refusing to discuss how to apply its principles beyond Twitter and Google, that moniker seems even more appropriate. For years, FDA declaimed its intention to not provide guidance that was limited to any specific platform(s) because of how rapidly the platforms evolved, and yet, ironically, it seems as if FDA is now intentionally doing exactly that.
FDA Was Wrong About Google Functionality
I didn't say very much about the use of Google text ads in the Regulatory Alert that I released last week about the FDA space-limited risk & benefit presentation guidance. Partly, that's because I'm working on an article about Google text ads that updates the chapter in my primer.
There is, however, one extremely important item to point out. FDA got sitelinks wrong. I don't mean that I disagree about the FDA's view on the use of sitelinks. I mean they don't understand the technology, and what they say in the guidance demonstrates that.
The FDA guidance recommends using sitelinks to include some risk information that the FDA says people must include if they are presenting product benefit information (and the product name). The example they give is:
In this example, the benefit information "For severe headache from traumatic brain injury" requires corresponding risk information to be balanced.
The FDA accomplishes that risk presentation via the various sitelink descriptions "Potential for brain swelling," "Life-threatening drop in heart rate," etc. Importantly, the words in the sitelinks themselves "Boxed warning," "Warning," and "Risk information" do not themselves constitute risk information, just links to risk information. Consequently, those links in themselves do not suffice to provide the risk information.
The first problem with this is that FDA is assuming that a product manufacturer can guarantee that their ads have the sitelinks and the link descriptions appear when they run the ad. But you don't have that control.
Google does not guarantee that sitelinks will ever appear. In fact, Google's page dedicated to sitelinks in paid search campaigns, includes a section header called, "Why your sitelinks aren't showing," and the first sentence under that header reads, "Keep in mind that your ads won't always show sitelinks."
That's a problem because if your ad is running with benefit information presented in the body of the ad, the ad requires the risk information to meet the fair balance requirement. If your ad displaying the benefit information does not include the sitelinks, then the ad would violate the fair balance requirement.
So, if the maker of HeadHurtz were to actually run the ad that the FDA provides as an example, there's a significant chance that the ad would actually appear as follows:
This ad would definitely be violative because as we learned in 2009, and as FDA reiterates in this guidance, if the product name and benefit information is presented, then FDA requires that some risk information be presented at the same time with comparable prominence as the benefit information.
So following the FDA's provided example could result in violative promotional activity. Moreover, even if the sitelinks appear, there's a chance that the sitelink description would not appear. But again, the sitelinks provided in the example ("Warning," etc.) do not in themselves provide risk information. So, just providing the sitelinks would not meet the fair balance requirement.
Further compounding the problems with the FDA's example is that the order and number of sitelinks provided varies without complete control by the advertiser. So, if all four sitelinks were not provided, there's a chance (based on FDA's guidance) that the advertiser might not be complying the fair balance requirement because FDA might deem it necessary to provide ALL four sitelinks to meet that requirement.
As if these problems were not enough, there's one more difficulty: mobile devices. If this ad were enabled for display on mobile phones (which is not required for Google ads but is encouraged), then you would definitely not have all four sitelinks presented, and none of the descriptions of the sitelinks would be presented.
So, the sample ad presented by the FDA could definitely not run on mobile phones, but of course, mobile access to the Internet is exploding, and in fact, some people (hint: me) believe that providing information via mobile devices is even more important than doing so via desktop.
There is, however, one extremely important item to point out. FDA got sitelinks wrong. I don't mean that I disagree about the FDA's view on the use of sitelinks. I mean they don't understand the technology, and what they say in the guidance demonstrates that.
The FDA guidance recommends using sitelinks to include some risk information that the FDA says people must include if they are presenting product benefit information (and the product name). The example they give is:
In this example, the benefit information "For severe headache from traumatic brain injury" requires corresponding risk information to be balanced.
The FDA accomplishes that risk presentation via the various sitelink descriptions "Potential for brain swelling," "Life-threatening drop in heart rate," etc. Importantly, the words in the sitelinks themselves "Boxed warning," "Warning," and "Risk information" do not themselves constitute risk information, just links to risk information. Consequently, those links in themselves do not suffice to provide the risk information.
The first problem with this is that FDA is assuming that a product manufacturer can guarantee that their ads have the sitelinks and the link descriptions appear when they run the ad. But you don't have that control.
Google does not guarantee that sitelinks will ever appear. In fact, Google's page dedicated to sitelinks in paid search campaigns, includes a section header called, "Why your sitelinks aren't showing," and the first sentence under that header reads, "Keep in mind that your ads won't always show sitelinks."
That's a problem because if your ad is running with benefit information presented in the body of the ad, the ad requires the risk information to meet the fair balance requirement. If your ad displaying the benefit information does not include the sitelinks, then the ad would violate the fair balance requirement.
So, if the maker of HeadHurtz were to actually run the ad that the FDA provides as an example, there's a significant chance that the ad would actually appear as follows:
This ad would definitely be violative because as we learned in 2009, and as FDA reiterates in this guidance, if the product name and benefit information is presented, then FDA requires that some risk information be presented at the same time with comparable prominence as the benefit information.
So following the FDA's provided example could result in violative promotional activity. Moreover, even if the sitelinks appear, there's a chance that the sitelink description would not appear. But again, the sitelinks provided in the example ("Warning," etc.) do not in themselves provide risk information. So, just providing the sitelinks would not meet the fair balance requirement.
Further compounding the problems with the FDA's example is that the order and number of sitelinks provided varies without complete control by the advertiser. So, if all four sitelinks were not provided, there's a chance (based on FDA's guidance) that the advertiser might not be complying the fair balance requirement because FDA might deem it necessary to provide ALL four sitelinks to meet that requirement.
As if these problems were not enough, there's one more difficulty: mobile devices. If this ad were enabled for display on mobile phones (which is not required for Google ads but is encouraged), then you would definitely not have all four sitelinks presented, and none of the descriptions of the sitelinks would be presented.
So, the sample ad presented by the FDA could definitely not run on mobile phones, but of course, mobile access to the Internet is exploding, and in fact, some people (hint: me) believe that providing information via mobile devices is even more important than doing so via desktop.
FDA Updates Mobile Apps Guidance DHLB Regulatory Alert Available
Updated to correct important error: Correcting "not" to "now" in opening paragraph.
On Friday, CDRH came out with a new guidance that included revisions to the previously finalized guidance from September 2013 about mobile medical apps. The most significant aspect of this guidance is that systems that simply transfer medical imagery and data from one platform to another will now face a significantly lower regulatory burden.
You can read the Digitas Health LifeBrands Regulatory Alert about this guidance here.
In many ways, this activity was foreshadowed by the update made earlier this week to the list of mobile apps that would receive enforcement discretion.
On a tangential note, the recent activity from CDRH on this topic is welcome because, in my view, it correctly demonstrates a willingness to update FDA's position as new information is released, but it does present some challenges for industry and some problems with the existing Good Guidance Practices, and FDA is clearly aware of some of these difficulties.
According to GGP, Guidances must be released in draft status with an initial period of comment of at least 90 days. Then, FDA has the option of finalizing the guidance unaltered, updating the guidance and releasing a revised draft, updating the guidance and releasing a final version, or doing nothing (in which case the guidance stays in draft status).
What we have in this case is FDA proposing a new draft guidance with edits to a previously finalized draft guidance, and at least as of today, there's nothing in that finalized guidance to indicate to readers that it no longer represents FDA's current position. I understand the desire to not retract a final guidance or change it back into a draft guidance for every update, but in this case, someone could easily read the final guidance and not realize that it is outdated.
It seems the far better practice is what CDRH is actually adopting, namely, maintaining a webpage that is more easily updated that a formal guidance document, but the status of the webpage versus the guidance documents themselves seems to create some tension.
Perhaps moving forward, FDA should limit the guidance documents themselves (because of the time-consuming process needed to update them) to the principles FDA is applying with more easily updated lists referred to in the guidances themselves.
Of course, if FDA's view about the regulatory status of a product, device, etc., is subject to revision too frequently, then clearly there's a deeper issue that needs to be addressed.
On Friday, CDRH came out with a new guidance that included revisions to the previously finalized guidance from September 2013 about mobile medical apps. The most significant aspect of this guidance is that systems that simply transfer medical imagery and data from one platform to another will now face a significantly lower regulatory burden.
You can read the Digitas Health LifeBrands Regulatory Alert about this guidance here.
In many ways, this activity was foreshadowed by the update made earlier this week to the list of mobile apps that would receive enforcement discretion.
On a tangential note, the recent activity from CDRH on this topic is welcome because, in my view, it correctly demonstrates a willingness to update FDA's position as new information is released, but it does present some challenges for industry and some problems with the existing Good Guidance Practices, and FDA is clearly aware of some of these difficulties.
According to GGP, Guidances must be released in draft status with an initial period of comment of at least 90 days. Then, FDA has the option of finalizing the guidance unaltered, updating the guidance and releasing a revised draft, updating the guidance and releasing a final version, or doing nothing (in which case the guidance stays in draft status).
What we have in this case is FDA proposing a new draft guidance with edits to a previously finalized draft guidance, and at least as of today, there's nothing in that finalized guidance to indicate to readers that it no longer represents FDA's current position. I understand the desire to not retract a final guidance or change it back into a draft guidance for every update, but in this case, someone could easily read the final guidance and not realize that it is outdated.
It seems the far better practice is what CDRH is actually adopting, namely, maintaining a webpage that is more easily updated that a formal guidance document, but the status of the webpage versus the guidance documents themselves seems to create some tension.
Perhaps moving forward, FDA should limit the guidance documents themselves (because of the time-consuming process needed to update them) to the principles FDA is applying with more easily updated lists referred to in the guidances themselves.
Of course, if FDA's view about the regulatory status of a product, device, etc., is subject to revision too frequently, then clearly there's a deeper issue that needs to be addressed.
Busy Week in Rockville (and Philadelphia)
CDRH has released a new draft guidance about mobile medical apps. Here it is.
I'm reading now and will have more later.
I'm reading now and will have more later.
FDA will not regulate Apple's HealthKit
In case you missed it, FDA has been updating its list of mobile apps where it intends to exercise enforcement discretion (on that concept in the FDA guidance on mobile apps see here and here). MobiHealthNews has a more extensive story here.
The most significant fact is that FDA has apparently added a new category that seems designed explicitly to include Apple's new HealthKit that was announced on the WWDC a few weeks ago.
h/t @wapgeekboy
The most significant fact is that FDA has apparently added a new category that seems designed explicitly to include Apple's new HealthKit that was announced on the WWDC a few weeks ago.
h/t @wapgeekboy
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