Pharma Facebook Advice – What FDA Expects

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Pharma Facebook Advice – What FDA Expects

April 2nd, 2013 // 2:45 pm @

What a former associate commissioner at FDA – Peter Pitts – thinks pharma should be doing in social media from FDA’s perspective.

Remember black and white television?  Remember when “cable” meant, “telegram” and “fax” meant the opposite of “fiction?”  Remember when watching a Fox network might get you slapped in polite company?

Having a web site does not replace having social media insight.    Change is opportunity.

Zig Ziggler said, “If what you’re doing isn’t working, try something else. If what you’re doing is working, try anything else.” While there are certainly anecdotal social media success stories, we’re losing the war. It’s time to reconsider what we’re doing.

The use of social media by regulated industry is faltering because of FDA-phobia, fear of being challenged by consumers, corporate timidity and misunderstanding over what social media really is.

Or as John Mack so delicately put it, “How can you use social media if your company doesn’t trust you?

During a past episode of Mad Men, the creative team at Sterling/Cooper was hard at work brainstorming on a “women’s product” campaign when someone asked, “What do women want?”

Strolling by, Roger Sterling quips, “Who cares!”

Well, when it comes to social media, what does pharma want – and who cares?

What pharma wants (or should want) is permission from the FDA to guide itself.

Industry’s general response to its tenuous toe-dips into social media is, “Blame the FDA!” But that’s not fair.

How can the agency be blamed for industry’s reluctance to push the boundaries – even a little? Fear of warning letters?  Fear of unearthing adverse events? I say, where there’s a will, there’s a way. If you won’t blaze the path – even a little – then don’t expect anyone to know where you want to go.

Unfortunately, blazing new territory through real-time learning is not, shall we say, historically a tradition of regulated industry.  Everyone wants to do new and exciting things – second.

The Dec. 27,, 2011, draft guidance, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” offers sound counsel but not much in the area of direct guidance. Nevertheless, there are valuable lessons to be learned – if you are willing to read between the numerated lines.

The draft guidance doesn’t address many of social media’s (referred to in the document as “emerging electronic media”) regulatory red flags such as adverse events, the question of property owner vs. property user, and a more precise discussion of what “sponsored” means.

But the giant regulatory bugaboo, not only of social media but of regulated speech writ large, is off-label communications. So those who are complaining this document isn’t “comprehensive enough” don’t understand what it has to offer.

Lesson #1: The agency is saying (in so many words) “if you wouldn’t say it off-line, don’t say it on-line.” It isn’t a question of platform-specific guidance (regulatory rules for YouTube or FaceBook or Twitter). Rather, the FDA is asking industry to use their best judgment in this new and, well, emerging media. That’s the good news.  The bad news is many folks in pharma find that frightening.

The agency recognizes companies are already responding to unsolicited requests for off-label information.  That means the current procedures companies have in place to address these requests are (when properly followed) FDA compliant.

Lesson #2: When trying to create processes and procedures for social media communications – draw parallels to existing communications processes and procedures.

That’s not, however, a get-out-of-jail-free card by any means.  Just as with traditional communications, there’s a great deal of regulatory ambiguity and use of the FDA’s favorite tense — the conditional tense: The role of legal and medical in the review of social media communications (relative to off-label issues and beyond) is still crucial.  This draft guidance doesn’t lighten the regulatory burden – it just makes it more feasible.

What it also says (IMHO) is that responding to unsolicited off-label communications is, indeed, in the best interest of the public health:

FDA recognizes that it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are addressed to a public forum, as other participants in the forum who offer responses may not provide or have access to information about the firm’s products.

The agency has, importantly, made a clear distinction between “solicited” and “unsolicited” off-label questions:

Unsolicited requests are those initiated by persons or entities that are completely independent of the relevant firm.  (This may include many health care professionals, health care organizations, members of the academic community, and formulary committees, as well as consumers such as patients and caregivers).  Requests that are prompted in any way by a manufacturer or its representatives are not unsolicited requests.

So, Lesson #3: The message being sent here is, “don’t get too cute.”  And that’s worth remembering. Using social media for marketing is okay – but using it to advance the public health takes precedence.

One key area that requires greater clarification (on the part of the FDA) is the definition of an unsolicited off-label request.” Does it have to actually be a question or could it also be a non-interrogative incorrect statement about the off-label use of a product?  Independent third parties who make erroneous statements about off-label use generally are ignorant of the fact that they are making factual misstatements.  Shouldn’t a company be able to respond to factual errors that aren’t in the form of a question?  Isn’t the whole idea here not to play Jeopardy with the public health?

The draft guidance makes it clear that misinformation is an important issue (one that also came up at the November 2010 FDA’s Part 15 hearing on social media):
The Internet has also spawned a variety of social media tools that host online content primarily created and published by users other than the intellectual property owner or product manufacturer.  In some cases, this online content may not be accurate.

Agency clarification is necessary so that companies can regularly and aggressively correct on-line misinformation about their products.

En suite, Lesson #4:  It is the responsibility of every company to correct product misinformation that it discovers not only in social media — but it all media.  After all, what would a company do if a factual mistake about one of its products appeared in the pages of the New York Times?

The draft guidance also offers some very sound and practical tactical advice.  For example, when dealing with off-label questions:

Information distributed in response to an unsolicited request should be provided only to the individual making the request directly to the firm as a private, one-on-one communication.

And:

If a firm chooses to respond to public unsolicited requests for off-label information, the firm should respond only when the request pertains specifically to its own named product (and is not solely about a competitor’s product).

Lesson #5: Take conversations about off-label use (and, IMHO, adverse events) off line and into existing processes and procedures.

The FDA requires some additional assistance in understanding social media.  Specifically:

FDA is also concerned about the enduring nature of detailed public online responses to off-label questions because specific drug or device information may become outdated (e.g., new risk information may become available).

While it’s good to be concerned, it’s also important to recognize that any piece of information ever written on social media (generally speaking) is going to be available forever for those who know how to find it.  Perhaps a better way to address this concern is:

Lesson #6:  Companies who respond to posts on independent third party sites should continue to regularly monitor those sites for future legitimate interventions.

Another questionable statement in the draft guidance concerns the use of “brand.com” sites as an inappropriate way to address unsolicited public off-label questions:

The public response should include a direct link to the current FDA-required labeling, if any, but should not include links to any other information (e.g., product websites, product promotional materials, firm websites, third-party websites).

Why shouldn’t a product website, assuming that every word on the site is appropriately compliant, be used?  Isn’t this where the most comprehensive, up-to-date, and accurate product information resides? If the agency is concerned about the legacy of “old” on-line information, they should support options that are regularly (and factually) updated – such as brand.com sites.

The draft guidance also raises the issue of communications with health care professionals and formulary committees. For both of these constituencies, seeking a regulatory parallel is useful. For healthcare professionals, the current guidance on Good Reprint Practices is as clear (and useful) for a social media interaction with a physician (or nurse-prescriber) as it is for a one-on-one office visit by a pharmaceutical company representative.

Lesson #7:  Social media means more than marketing products. It means using this “emerging electronic media” to advance the public health by communicating factual and timely information.  In short – sharing knowledge with those who want it, when they want it, where they want it.

Lesson #8:  Not just when a marketer wants to.

Lesson #9:  It’s about judgment. If a company can make a strong case (internally and honestly) that a social media engagement truly advances the public health, it’s a strong foundation for ensuring compliance.

Lesson 10: Pharma, Guide Thyself.

What are the odds, lacking direction, expertise and experience, that FDA will deliver some kind of future deus ex machina solution?  Expecting the Holy Grail will only lead to disappointment and frustration. If industry is expecting to climb the steps of the agency’s headquarters at White Oak on its knees, kiss an FDA relic and miraculously throw away the crutches hobbling their ability to participate in social media, well, there had better be a Plan B.

I’d like to make five main points that are often overlooked or misconstrued when we discuss social media in the context of regulated speech:

There is a difference between online advertising and social media

When the FDA sent out the “famous 14” warning letters on sponsored Google links, many pharmaceutical regulatory review professionals said, “See, told ya – you can’t use social media,” and breathed a secret sigh of relief – another sign of an ever-growing regulatory Stockholm Syndrome.

But they were wrong; because when you read the letters it becomes quickly evident that DDMAC (now reincarnated as OPDP) equates “sponsored links” not with social media – but with paid advertising.  In the context of those letters, “sponsored” equals “paid.” And there are rules for that.

Beware, because as Disraeli said, “A precedent embalms a principle.”

There is a difference between social media platforms and social media content

FDA sent out a warning letter regarding a YouTube video where a paid celebrity spokesperson said that a drug had “cured” her disease (a decidedly off-label claim, shades of Dorothy Hamill and Vioxx). And some internal reviewers industry-wide said, “See, you can’t use YouTube. Not so.

If the content is non-compliant, then it is non-compliant regardless of platform. On the positive side, I believe the reverse is also true.

Remember, OPDP Director Tom Abrams has made it clear that there will NOT include agency direction on how to use specific platforms such as YouTube or Facebook or Twitter – and that includes emerging mobile platforms too.

The fear of adverse event discovery is dangerous and misguided

Industry’s regular and public social media “AE-phobia” only reinforces the public’s erroneous notion that industry communications are solely about money and marketing – and the public health be damned.

If industry is not afraid to mix it up in real time with real people – then it needs to walk the walk. Social media abhors a vacuum.

We must embrace and rejoice in social media’s capability to unearth adverse experiences early and often. Quod erat demonstrandum.

The fear of user-generated content and off-label conversations is real … but

There are a multitude of solutions, ranging from moderating comments (which are generally accepted by social media communities as long as they understand the necessity for such moderation) to corporate responses directing the user to a given product’s PI and pre-vetted company web pages.

But these tactical solutions don’t solve or even begin to address the issue of “property owner” vs. “property user,” an issue that was mentioned by the FDA in its Federal Register notice for its November 2009 Part 15 hearing.

That’s an issue the FDA would be wise to address – and sooner rather than later.

Who’s responsible for what?

Social media is a big place. Can any single company be held responsible for what’s said about itself or its products anywhere online?

Consider the current on-the-books guidance, which reads, “Applicants should review any internet site sponsored by them for adverse experience information, but are not responsible for reviewing and internet sites that are not sponsored by them.”

But what does “sponsored” mean?

Consider the oft-heard TV voice-over, “This portion of the Masters is sponsored by (NAME OF ERECTILE DYSFUNCTION PRODUCT).

Nobody in the viewing audience thinks the sponsor chose the speed of the greens or the pairing of the golfers, or the height of the rough.

But say, “sponsored” on interactive social media and watch the sparks fly at internal regulatory review.

It would be very useful for the FDA to also clarify, among other things, what “sponsored” means.

At the end of the day, the issue of social media and FDA regulations was summed up nicely by another senior member of the FDA brain-trust who told me privately that, “We need to learn to talk to people the way they talk to each other – and that’s going to create a culture shift at the FDA.”

Social media requires interactive engagement in real time.  It requires you to play rather than purchase.  And that’s a wonderful opportunity – because you cannot purchase passion.

Mario Andretti said that If everything seems under control, you’re not going fast enough.

As social media participation by regulated healthcare companies continues its slow slog forward, here are some issues to ponder:

* Intent.  Internal company debates often focus on responsibility for what happens after a corporate comment is posted.  And that’s important.  But what’s more important is what drove the company’s decision to make the post in the first place.  What was the intent? Was it marketing-driven or was it done in the best interest of a patient or the broader public health?  Intent counts.  Just as the FDA has asked whether or not the speaker and the audience matters when it comes to the issue of “scientific exchange,” so too is this relevant in helping to determine “responsibility” for what takes place on a social media site post a company’s post.

Does this mean that (at least initially) regulated healthcare speech in social media will be more corporate (vs. product) driven?

* Control. When it comes to the “property owner vs. property user” question – what is the difference between “sponsorship” (generally defined by an exchange of money) and “control” (a more ambiguous but no less important concept)?  If you control something, then can you be considered able to prevent something from happening – such as a discussion of off-label use?

* Environment. If you buy a banner ad on Google, that’s advertising. But if that ad appears above an organic search that you do not either sponsor or control – are you responsible for the broader environment of that page? Perhaps the best way to approach that question is to offer this thought experiment – If you decided to run a commercial for a statin on the evening news and, during the course of the program, there was a feature on off-label use of statins – would you be responsible for the environment?

* Safety Information. Is it a good thing or a bad thing for consumers to spend more time interacting with important safety information? Of course it’s a good thing. So here’s a question that’s calling for some solid research – do consumers spend more time with ISI via the traditional off-line “brief summary” and patient package insert, or on-line via click-throughs?  Inquiring minds want to know. If it is the latter, then that would further strengthen the argument that its important for regulated healthcare companies (on both corporate and product fronts) to participate in social media for the public good.

* Commitment. Perhaps the one thing that is the toughest to internalize is that social media is a commitment – not a tactic. Obvious financial and FTE implications here, but more frustrating is the fact that participating in social media means playing with irrational actors – like patients.

So much for “control.”

Rather than rubbing the magic lamp and wishing for FDA guidance, we need to burn the midnight oil and work harder to make healthcare communications via social media a reality – because an educated consumer really is industry’s best customer.

Social media is the Health Care Hunger Games of pharma – predictable, juvenile and – portending grander themes and schemes. How many times have you heard (vis-à-vis social media and healthcare) that, “Pharma is different.” That’s true – but consumers are the same. They don’t think about why pharma is absent from the conversation – and they don’t care.  They assume it’s because the industry “has something to hide” or that they’re afraid of mixing it up with real people in real time.

And there’s more than a little truth to that.

Is social media about “collaborating” with consumers or “cooperating” with them?  What’s the difference?  Well, cooperation happens when both sides want to survive.  Collaboration happens when they want to thrive. Collaboration means interacting honestly and transparently. And pharma’s opportunity (within the context of social media) is to be the first among equals.

Success for pharma in social media will come through collaboration. And that doesn’t mean, “selling.”

Transparency (via social media) is leading to erosion in trust of once sacrosanct gurus such as physicians, corporate spokespeople (and their avatars) and other “experts” (not the least of which is the mainstream media).

It’s been a painful and swift denuding of influence. Rather than being slowly disrobed, yesterday’s unquestioned experts have been roughly stripped of their influence and authority.

You can’t airbrush social media.

While various “emperors” are being exposed as having no clothes, the void is being filled with robust and real-time peer-to-peer communications. Alas, there are also many ascendant false prophets. The Internet is full of them. Some are well-meaning (but still dangerous) idiots, others are pure charlatans.

Social media is a wonderful “green field of opportunity.”  But to maximize the opportunity, we must accommodate the reality of a messier world.  Social media, almost by definition, is messy – and the regulatory framework (or lack thereof) is equally so. And it’s not likely to get much better. Get used to it.

Nobody said it was going to be easy. We need to change the healthcare paradigm and changing the way people learn, discuss and address healthcare issues is a crucial element. And it is changing rapidly.

 

Impact and influence happen when what you have to share is to the benefit of the seeker — not to you.  And that requires a level of focus, acumen and honesty that is always hard and often lacking – and especially when it comes to healthcare marketing. As the saying goes in our nation’s capital, “if you’re not at the table, you’re on the menu.”

As NIH Director Francis Collins recently said, “We are living in an awkward interval where our ability to capture information often exceeds our ability to know what to do with it.”

Collins’ comment was directed at the complete human genome sequence – but is equally germane to an equally complex human proposition – social media.

And may the odds be forever in your favor.

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