A technical analysis of compliance in the context of the FDA’s draft guidance

By Paul Grant

Unless you are still enjoying an extended vacation following the Christmas and New Year’s holidays, you will have undoubtably heard that the FDA has released its draft guidance on the use of ‘interactive promotional media’. As is most often the case, many excellent commentators have weighed in with their summary of what the document may mean for pharmaceutical and healthcare companies. Here are just some of them at the time of writing:

Rather than cover the same ground, I would in this article like to take some time to deconstruct the document from a technical compliance perspective, to stimulate debate and to think about what work may yet need to be done so that the industry can truly embrace such ‘interactive promotional media’. It’s a long read, but hopefully in manageable chunks.

“…I would in this article like to take some time to deconstruct the document from a technical compliance perspective…”

Just do what is right

Let’s start with line 9 and the document caveat around ‘…current thinking’. Herein is the fundamental challenge for industry in understanding interactive content. Interactive content changes. We can only ever draw a line in the sand and say – this is where our current thinking is at. I recall working with a pharmaceutical company on a distributed content strategy across multiple social channels and platforms. Indeed there was not even a ‘website’ at all, which was a first for its time. What happened? Well all of the platforms changed over time, so that the previously approved campaign was no longer compliant – even by its own high standards.

With that said, my first question is how will this guidance be maintained and kept up to date? Given I know that it is not plausible, such guidance needs to be open-ended and timeless. But wait, isn’t that what the basic tenets of regulation around the promotion of medicines has always been? Yes. As I say to my clients, “you know what is right, so don’t inappropriately promote your products”. It is that simple really. Do we need a new guidance on interactive promotional media? Sure, why not – but with the caveat that it is only there to challenge our thinking and to provide a starting framework.

To the credit of the FDA, I think they know that too. Hence why the following sentence says “you can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations”. There it is, just do the right thing ethically and morally and in the context of the law.

What is a modern tool?

In line 22 we hear of ‘modern tools’. Well I would suggest we remove that term. What is ‘modern’? Forums (or fora if you prefer) have been around for decades and yet it is actually the use of forums by the industry that is really the issue of contention. As is often the case, it is not the tool, it is the application of promotion to communication.

Overtly or indirectly?

In line 24 the key point is that ‘…firms use to promote their drugs.’ There is a distiction to be made here; is the firm explicitly seeking to promote their drugs through the use of a channel, whether indirectly or overtly? If so, it is surely subject to review. If not, well does it require a blanket rule for approval? I would argue possibly not! Indeed with one client, we have been developing a concept of ‘agile approvals’, something that I will elaborate more on as we review this draft guidance.

Is volume the main challenge?

In lines 32 and 33 we have what the FDA purports to be a key challenge – the ‘…volume of real-time information’. On this I agree it is one challenge, however equally important and to be addressed is the expectations of a social community in receiving a response in a timely manner. This is one key driver of the case for a more flexible approvals system which accounts for the needs to have a non-complex process for interacting with communities. Naturally there is content which by all common sense requires pre-approval, however there is so much that doesn’t. I’m sure you are thinking of examples even as you read this.

Discretion required

Line 73 is quite interesting, “FDA intends to exercise enforcement discretion”. Well I think this is laudable and I commend the FDA for taking a view that action taken in relation to interactive promotional media must be in the context of the situation. Really, a firm needs to consider whether any action it takes can stand the ‘red-faced’ test i.e. ‘has this been undertaken in good conscience and in the spirit of the law?’. If so, there is little to worry about.

What a fine specimen

In line 94 we hear of the applicant submitting ‘specimens’ of promotional material. I like this, however I am almost certain that my definition of specimen is a little different. In one project, using real-time media, the client had a need to produce great variety in their messages, that would be essentially broadcast through a social channel. Rather than conceive of every possible message verbatim, we developed a ‘message matrix’ which contained a piece of information, a call to action, a tag, and a link. All of these message segments had numerous variations, so that permutations and combinations could be created to produce the required variety – but with simplicity in terms of the size of the approval package. The legal and medical review acknowledged that there was no conceivable way for these messages to contain a medical inaccuracy or non-compliant message, so were happy to approve the components rather than the final messages. Such flexibility is one approach, which if considered appropriate by the FDA would mean content could be submitted as ‘specimens’ while not necessarily representing all that might be broadcast. Specimens in the loosest term may also encompass ‘we are going to reply to people in a human tone like this’. Ah, but herein lies a challenge for regulators – who is actually being protected, the firm/regulater/approver or the patient?

Rogues, influence and firm responsibility

Section IV opens up some issues which are longstanding in my mind. Who is responsible for third parties? When and how is the influence of a firm exerted? Actually, all employees and subcontractors are to some extent influenced by the agenda and business objectives of the firm that they work for. Yet I would argue that it is not practical for a firm to be responsible for this, that is, unless the firm explicitly solicits or requests an individual to produce a communication. The key question is whether a piece of content has been produced ‘on behalf of the firm’. Where an employee or subcontractor expresses a spontaneous and perhaps non-compliant opinion, we should think carefully about whether that is the firm’s fault. Consider, an employee who experiences a mental breakdown and takes to Twitter or Facebook posting messages about a firm’s products. Yes, the firm is responsible for the conduct and wellbeing of its employee or subcontractor, but I would argue they are not responsible for the content unless it was produced under instruction. That is contentious I know, and flies in the face of all the ‘my tweets are not my own’ rubbish that we see all over the Internet in these days.

Why the industry is fearful

In Line 119, ‘…whether the firm, or anyone acting on its behalf, is influencing or controlling the promotional activity or communication in whole or part‘, is an example of the type of sentence which is somewhat ambiguous in the context of other pieces of this document, but if taken at face value – as a standalone message – would prevent any right-minded firm from embracing interactive promotional channels at all! Here it implies that the firm is essentially always responsible for everything. In reality, we know from elsewhere in the document that the application of guidance is discretionary and must consider the context of whether a firm has initiated an activity to drive business objectives. Yet, try explaining that to a risk-averse lawyer or medical reviewer.

Where do we draw the line?

At what point does responsibility stop? The nature of social content is that it is syndicated and re-purposed to suit the context of the person sharing. Surely a firm can only be responsible for the words they construct and use. If a third party adapts those words then the liability has to rest with that party. If they are not directly connected to the firm as an active proponent in the promotion of the product (under contract) then a line should be drawn.

Approve the content or the approach?

After reading through Example 1 (line 125) it strikes me that the nature of a social platform is that actually it should change dynamically to be successful and engaging. Whilst managed and moderated, the firm should only be responsible for whether it adheres to its own predetermined management policy in regards to keeping promotional messages balanced. For example, a user posts a positive message about a product and the firm replies with a message that adds balance or reminds the community of the terms of participation. How quickly should this happen, and at what point is there a lack of compliance? This is at the discretion of the FDA and will largely be based on their capacity to police such cases. Is the FDA going to monitor all of social media looking for breeches? Certainly, I would be looking at whether a firm is fulfilling their responsibility as determined through their pre-approval package.

But we only paid for it!

Line 135-6 provides the expected ‘arms-length’ caveat. Rightly so, but is this the clear delineation of whether something needs to be reviewed or not? In my opinion this is a ’no-brainer’, still possibly useful to see in print for the benefit of those new to the industry. Where I am more interested, is in the detail of the words ‘any control or influence’. I think we are on the right track in line 141, in terms of the content and influence that is provided to a third-party. By my reasoning, it would make sense to submit for review the actual influence that was exerted, not the results. That being said, once the third-party implements the content – everything changes. At that point the liability should move away from the firm. Consider a case of in-text advertising or other decisions made by the site owner which completely change the package on which permission was originally granted.

Employees and agents

Line 160 and following really starts to explore the issue of employees and agents in more detail. As discussed above I maintain that we have the wrong emphasis in relation to responsibility here. Yes, the firm is responsible for conduct – no, not content necessarily unless they have exerted influence on the individual to produce it.

Changes which may harm the public

Footnote 6 on page 5. OK, so this needs further discussion. Why? What constitutes a change? My feeling is that a change is something which either:

  1. solicits information
  2. has a data privacy implication
  3. makes a claim
  4. refers to a product.

All other items which change should be of no consequence and only cause delays in the provision of accurate information to the public. The cost of approving content internally and externally must be proportionate to the risk of harm. This is the premise behind ‘agile approvals’. So your number of employees changed from 5,893 to 5,897 and you want to update the website – why not? Does the entire site, or even the page need re-approval? As long as there is an audit trail which shows that a suitably graded employee has made the decision that the page did not require full legal and medical review, shouldn’t this be enough?

It ain’t over ’til its over

In line 234 we have the exit strategy, of sorts. However, in my experience there is more to this story. At what point is the firm no longer responsible for their participation in that third-party site, given that the legacy content will remain – potentially stimulating debate and further comment? I have been privy to projects which used so-called “active listening”, where a researcher has transparently represented a firm in user-generated forums to stimulate market research responses. Now, those forums still exist, the questions still generate responses, but the firm has long ‘left the building’ and the project has long since completed. What then is the responsibility? Where is the cut-off and do we not need to be more clear about exit strategies in engagement channels?

The archive to end all archives

So in line 246 we get an understanding of the sheer quantity of content which will be submitted. It brings a smile to my face, as this is where process and risk-mitigation move into the realms of counter-productivity. I mean what resource is required by both the firm and the regulator to trawl through all of this? Why submit ongoing reports at all? Surely an industry complaints process would sufficiently catch cases of non-compliance?

Oh yeah, and make it interactive

Well, I confess that footnote 7 on page 6, ‘submit the interactive or real-time communications in an archivable format that allows FDA to view and interact with the submission in the same way as the end user (e.g., working links)‘, gave me an ‘almost LOL’. It may just be that my cynicism increases proportionately to the length of legal documentation.

In conclusion

Fantastic. I love this document from the FDA and the commentary it is attracting. Hopefully the above adds something else to the melting pot or at least gets you thinking about innovation within the constraints of regulation. All I can say in conclusion is that for myself and the rest of the strategy team at Creation Healthcare it looks like business as usual!

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Paul Grant