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Bill to force FDA adoption of the industry-proposed “One Click” rule?

Senior Director, Social Media

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What would you say if I told you that the “one click rule” is now in a Bill making its way through the political process in Washington and if passed would compel the FDA to accept it as an adequate way to handle safety information in space-limited channels? We at Klick Health say “yes please.”

On Tuesday, January 27 the House of Representatives’ Energy & Commerce Committee started promoting a bill that has been in development for a while: The 21st Century Cures Bill, drafted by the Health Subcommittee, currently in “discussion document” phase. This document is a giant bill that has five major sections:

There are two parts that healthcare marketers care about in this bill. They relate to:

Social Media and the “One Click Rule”

The Bill under discussion instructs the FDA to accept linked safety information as adequate for digital communications in space-limited channels. There really is no wiggle room here for the FDA, if this Bill passes then the regulator has 12 months to review regulations and issue guidance telling companies they can use space-limited channels for branded conversations and that a link to important safety information (ISI) is adequate for regulatory purposes. This will cause the FDA to completely rewrite their existing guidance on these channels.

For those who only believe what they can see for themselves, next is the verbatim text from the Bill itself.

Verbatim Text

The verbatim from the Bill (pages 92-93):

(1) review each regulation and guidance that applies to the dissemination by means of the Internet (including social media platforms and character-limited applications) of information about medical products; and

(2) propose revisions to such regulations and guidance (in the form of proposed amended regulations and draft guidance, respectively) that—

(A) facilitate meaningful use, by the sponsors of medical products, of the Internet, including Internet applications and social media, for dissemination of truthful, nonmisleading information about medical products;

(B) recognize that such sponsors may use the Internet—

(i) to disseminate, in character-limited applications, truthful, introductory information about medical products, including the name of such products and their approved uses; and

(ii) to provide additional information about the safety and effectiveness of the medical products using information that is hyperlinked to such introductory information; and

(C) for regulatory purposes, treat hyperlinked information described in subparagraph (B)(ii) as if the information appeared in introductory information described in subparagraph (B)(i).

If this Bill is passed into law, the FDA will be directed to accept the one-click rule in “character-limited applications.” It is not too much of a stretch to assume this will apply not only to social media such as Twitter but to search engine ads as well. The Bill gives the FDA only 12 months to review regulations and guidance and propose changes. It is unclear how long it would take to make the regulations official although healthcare marketers are typically willing to act on guidance immediately if it makes sense.

Of course, that is only “if” the Bill passes with the current wording.

Mobile Medical Apps

The other directive of interest in this Bill is surrounding the definition of a Mobile Medical App. The section which includes this information is titled “Sensible Oversight for Technology Which Advances Regulatory Efficiency.” The wording here implies that perhaps the current regulatory environment isn’t “sensible.”

The FDA guidance documents claimed that they were bestowing the app categories with “regulatory discretion” whereas the Bill looks to draw a clear line between what the FDA does, and does not, regulate and remove the possibility of the FDA interfering with any categories outside its purview. However, whereas the space-limited social media section was clear and unambiguous, it seems that the Health subcommittee ran into the same definition issues that have plagued the FDA when it tries to provide Mobile Medical App guidance (as reported in Digital Rx here and here).

What the Bill wants to do is create three categories:

Medical Software

The Bill instructs the FDA, within 24 months, to set up an entirely separate process for certifying “medical software.” This process will be documented by “standards, policies, and procedures” for:

This looks like it would replace the current policy of using the 510(k) certification process (in fact the bill mentions three: 513, 510(k), and 515) for tools such as mobile medical apps that are deemed to be “medical software.”

The Bill further instructs the FDA to include specific types of participants in 6-month workshops before making draft regulations binding:

Health Software

This software is defined specifically as not medical software or a component [of a medical device] but is still intended to be used for healthcare purposes. The authors of the Bill are struggling with the definition here as the Bill includes the aside:

How do we ensure that products that have features that should be regulated as medical software or medical devices or components thereof are not exempted from regulation as such products?

Essentially, they want the same outcome as the current FDA guidance: control the software that has the potential to harm patients but to ignore software that does not. This piece of the Bill will almost certainly be subjected to more discussion as issues such as the presentation of data vs. the suggestion of a diagnosis are hashed out.

History of this Conversation

This Bill has been in development for a while, and has had multiple inputs. The Committee’s Facebook page listed the efforts so far:

The #Cures2015 infographic from the E&C Committee Facebook page

The #Cures2015 infographic from the E&C Committee Facebook page

Looking at the history of the hashtags shows a topic that spikes around Committee events:

Mentions of #Cures2015 and #Path2Cures on all social media over 12 months

Mentions of #Cures2015 and #Path2Cures on all social media over 12 months

The current Congress has nearly two years left in its mandate, and the bipartisan Committee makes a point of talking about how both sides are working together, so there is no particular reason to think this Bill will die. But, like all politics, it’s anyone’s guess as to how it proceeds.

You can also download the POV: FDA 21st Century POV (1.0) for internal use.

Download the Klick Health POV


I’d like to give a shout out to the folks that brought this up:

More About the Author

Brad Einarsen

Brad is Klick's Senior Director leading the social practice. His group ensures that clients get the best bang for their buck on the social platforms.

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