Despite what you might think, the various actions and directives emanating from White Oak tell a very liner story with very steady red thread – and that thread is the difference between communications and marketing.
To many in pharmaceutical company marketing and regulatory review departments it may seem a distinction without a difference. But that’s a fundamental misunderstanding of the FDA’s mindset when it comes to social media.
As Casey Stengel used to say, “Let’s look at the record.”
In April of 2009, the FDA send out 14 warning letters on sponsored Google links – and many pharmaceutical regulatory review professionals said, “See, told ya – you can’t use social media,” and breathed a secret sigh of relief – the first sign of an ever-growing regulatory social media Stockholm Syndrome.
But they were wrong; because when you read the letters it becomes quickly evident that the FDA’s then Division of Drug Marketing, Advertising, and Communication properly equated “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.
Even before the famous 14 Google letters, in September 2008, the FDA sent out a warning letter regarding a YouTube video in which a paid celebrity spokesperson said that a drug had “cured” his disease (a decidedly off-label claim, shades of Dorothy Hamill and Vioxx). And many internal reviewers industry-wide said, “See, you can’t use YouTube.” Not so. Read the letter. If the content is non-compliant, then it is non-compliant regardless of platform. It’s the content that counts.
In March 2013, there was much angst over the FDA’s Warning Letter to AMARC Enterprises because of their Poly Mva FaceBook page. Aha! said our friends in legal and regulatory review said – you can’t use FaceBook!
The gist of that letter is that the company is marketing its veterinary dietary supplement as a human oncology drug. OPDP spends a lot of space on violative claims made on the company’s website and then – at the very bottom of the letter – addresses the issue of FaceBook. The OPDP writes that, We also note that your Facebook account includes a post which was “liked” by “Poly Mva”:
“Poly MVA has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation…Thank you AMARC”
That’s a violative statement on any media platform. It just happened to take place on FaceBook. And the letter was rather prescient when you consider the FDA’s most recent social media draft guidance of June 2014, Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices:
If a firm chooses to respond to misinformation about its products using non-truthful or misleading information or in a manner other than that recommended in this draft guidance, however, FDA may object if the information provided by the firm does not comply with applicable regulatory requirements related to labeling or advertising, if any.
“Liking” a violative third-party statement on your own FaceBook is violative behavior. Not rocket science and a clear and clarion call to the distinction between communications and marketing.
Now let’s go back in time to the agency’s December 2011 draft guidance, Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.
This 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 complained this document isn’t “comprehensive enough” don’t understand what it has to offer. Most importantly, it continues the red thread of marketing vs. communications, expanding in a crucial way to off-label marketing vs. off-label communications.
Consider the following verbiage from the draft guidance:
FDA has long taken the position that firms can respond to unsolicited requests for information about FDA-regulated medical products by providing truthful, balanced, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request, even if responding to the request requires a firm to provide information on unapproved or uncleared indications or conditions of use.
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.
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:
Statements that promote a drug or medical device for uses other than those approved or cleared by FDA may be used as evidence of a new intended use.
In other words, 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.
The draft guidance makes it clear that misinformation is an important issue:
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.
Which brings us to the June 2014, Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.
For those of you not currently on NoFocus therapy, you will remember the 2009 Part 15 hearing on social media – the “SuperBowl of FDA Part 15 hearings.” One of the key questions the agency wanted to discuss was how to correct erroneous product information. All they got were blank stares and request for FDA guidance. Five years later – voila!
The agency writes:
This draft guidance is intended to describe FDA’s current thinking about how manufacturers, packers, and distributors (firms) of prescription human and animal drugs (drugs) and medical devices for human use (devices) should respond, if they choose to respond, to misinformation related to a firm’s own FDA-approved or -cleared products when that information is created or disseminated by independent third parties on the Internet or through social media or other technological venues (Internet/social media), regardless of whether that misinformation appears on a firm’s own forum or an independent third-party forum or website.
Key take-away is that the decision to correct errors is purely voluntary. (But, then again, technically so are all product recalls.) Where that becomes more complicated is how companies may choose to cherry-pick where they interceded for corrective purposes. This is not an issue addressed by the FDA in this draft guidance. One thing this all means is more work for legal and regulatory review.
This draft guidance is all about user-generated content. The agency writes:
The Internet and Internet-based technologies have made it easier for third parties who are independent of firms to disseminate information about drugs and devices. Information created by third parties (which for purposes of this guidance is user-generated content (UGC)) might appear on an interactive portion of a firm controlled website or other interactive Internet/social media platform, or information might appear on a website or other Internet/social media platform that is independent of, or not under the control or influence of, a firm.
Many Internet/social media platforms allow for real-time and continuous communications and interactions (e.g., blogs, microblogs, social networks, online communities, and live podcasts) while other platforms do not provide a means for interactive content to be posted. Whether a forum is interactive may affect the means by which a firm is able to respond to information.
And, the agency stipulates, “UGC might not always be accurate and may be dangerous or harmful to the public health.” Well, yes. What’s a manufacturer to do?
Five years later, some helpful advice from the good people at White Oak.
Specifically:
If a firm voluntarily corrects misinformation in a truthful and non-misleading manner and as described in this draft guidance, FDA does not intend to object if the corrective information voluntarily provided by the firm does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising, if any.
From a regulatory perspective, that’s a lot of wiggle room and should provide significant food for thought in erring on the side of more rather than fewer voluntary corrective actions.
But (per 12/11) guidance:
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).
Forewarned is Forearmed. Don’t get to cute. Follow the red thread.
The June 2014 draft guidance isn’t about sponsored communications. The agency writes:
This draft guidance does not apply when a firm is responsible for the product communication that contains misinformation. A firm is responsible for communications that are owned, controlled, created, or influenced, or affirmatively adopted or endorsed, by, or on behalf of, the firm.
A firm is thus responsible for communications on the Internet and Internet-based platforms, such as social media, made by its employees or any agents acting on behalf of the firm to promote the firm’s product, and these communications must comply with any applicable regulatory requirements.
Specifically:
… this draft guidance applies when a firm is not responsible for a product-related communication that appears on the firm’s own forum, an independent third- party website, or through social media, and the firm chooses to correct misinformation about its own product contained in that communication. In such cases, we recommend that the firm do so as described in this draft guidance.
Here are the agency’s eight ground-rules for “appropriate corrective information;”
* Be relevant and responsive to the misinformation;
* Be limited and tailored to the misinformation;
* Be non-promotional in nature, tone, and presentation;
* Be accurate;
* Be consistent with the FDA-required labeling for the product;
* Be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs;
* Either be posted in conjunction with the misinformation in the same area or forum (if posted directly to the forum by the firm), or should reference the misinformation and be intended to be posted in conjunction with the misinformation (if provided to the forum operator or author);
* Disclose that the person providing the corrective information is affiliated with the firm that manufactures, packs, or distributes the product.
Truthful. Accurate. Transparent. Three good rules of thumb. But what about “timeliness?” No advice from the agency on this one – but something crucial for manufacturers to consider since the goal here is to protect the public health.
Again, the agency offers important nuance on how to correct. For example, don’t just correct one mistake when multiples ones appear. The draft guidance also offers absolutely critical commentary relative to the depth and breadth of responsibility when correcting one piece non-sponsored UGC, “The firm is not expected to correct misinformation that appears on other webpages of the website.”
Those sweet sixteen words address a world regulatory angst.
Further:
Once a firm undertakes the correction of misinformation, FDA does not expect the firm to continue to monitor the website or communication that previously included UGC containing misinformation.
This does, however, point to the need for individual companies to develop their own policies in this regard. More work for legal/regulatory review teams!
And, for those of you who are thinking a little too hard, consider this important caveat:
… if a firm chooses to correct only misinformation that portrays its product in a negative light in a third-party communication but does not address misinformation that overstates the benefits of its product in that same clearly defined portion of the communication, the firm’s actions do not meet the recommendations in this draft guidance.
Voluntary corrective action isn’t just about “bad” information. Another nod to the distinction between marketing and communications.
And, importantly:
FDA recognizes that a firm cannot control whether an independent third party refuses to correct the misinformation, or corrects only a portion of the misinformation even though the firm provided complete corrective information, or declines to include the respective required labeling, or declines to remove misinformation, or does not correct all the misinformation in one clearly defined part (if the firm sought to correct more than one piece of misinformation). Accordingly, FDA will not hold a firm accountable for an independent third party’s subsequent actions or lack thereof.
The perfect shall not impede the public good.
And, lastly:
FDA does not expect firms to submit corrections to the Agency when correcting misinformation pursuant to this draft guidance; however, FDA recommends that firms keep records to assist in responding to questions that may come from the Agency. The records should include, for example, the content of the misinformation, where it appeared, the date it appeared or was located, the corrective information that was provided, and the date the corrective information was provided.
A few words (no pun intended) on the other June draft guidance for Industry Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.
The agency writes:
Risk information should be comparable in content and prominence to benefit claims within the product promotion (i.e., a balanced presentation). Achieving a balanced presentation requires firms to carefully consider the desired benefit claims and risk profiles for their products when choosing a promotional platform.
That’s good advice – choose the platform that best suits any given communications need. But, it’s not really any communications need – it’s any promotional program. That’s important because promotional speech is regulated speech. And that’s not just regulatory rhetoric. And this begs a crucial question not covered in the draft guidance – What it the intent of the communications?
Don’t wait for the FDA to offer guidance on that. They will not and should not. That’s a question only the communicator can answer. And it needs to be done honestly and early in the communications development process. Is it a marketing strategy or a service to the public health?
The agency writes:
FDA acknowledges that Internet/social media platforms associated with character space limitations may pose challenges for firms in providing a balanced presentation of both risks and benefits of medical products, as discussed above … The firm should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product.
It’s not Brief Summary, it’s Tweet Summary.
The agency’s most important advice appears on Page 12 of the draft guidance:
In communicating risk information on Internet/social media platforms with character space limitations, firms should consider the following points:
1. Risk information should be presented together with benefit information within each individual character-space-limited communication (e.g., each individual message or tweet).
2. The content of risk information presented within each individual character - space-limited communication should, at a minimum, include the most serious risks associated with the product.
3. A mechanism, such as a hyperlink, should also be provided within each individual character-space-limited communication to allow direct access to a more complete discussion of risk information about the product … the Agency recommends that a direct hyperlink to a landing page that is devoted exclusively to comprehensive risk information about the product be initially included within the original character-space-limited communication.
Not rocket science, but urgently important to remember when considering both the design and appropriateness of a limited-character platform. Also, the use of hyperlinks is crucial. (Note – the agency makes it clear that a link’s name should also be considered. Specifically, it shouldn’t be a claim (i.e., www.bestcancercuredrug.com).
Marshal McLuhan wrote that, “At electronic speed, all forms are pushed to the limits of their potential.” Now replace “electronic” with “digital” and you have a good headline for both the obstacles and the opportunities of social media for regulated industry. The challenge, as James Fowler of the University of California, San Diego puts it, is for Pharma to “recognize its network potential.”
And that’s potential not just for marketing, but for public health communications. It is the convergence of social media and social marketing.
Ian Read (Chairman and CEO of Pfizer and the current Chairman of PhRMA) recently published a piece on LinkedIn under the title, Why Society Needs a Vibrant Pharmaceutical Industry: Improving Patients' Lives.
Read writes:
As an industry we are working diligently to improve our standing in society. We understand that we have a great responsibility. We are at the center of society’s desire and expectation for delivering potential cures and new lifesaving treatments. We will continue to fulfill that vital purpose.
Fine sentiments and well-crafted words – but working hard alone isn’t enough to earn trust. Pharma must work hard to do the right thing.
The genesis of Mr. Read’s philosophy began (at least publically) this past April at PhRMA’s 14th annual meeting in Washington DC.
During his inaugural remarks as incoming PhRMA board chair Read shared his concern about the industry’s failure in getting the message out about “the value we generate.” His key message, “We need to fix the misperception gap.”
Specifically he talked about the industry’s need to broaden the conversation from the economic performance of biopharmaceutical companies to the value that accrues to society and called for a “dialogue with society.” Bravo.
Pharma must embrace a new paradigm. Rather than focusing on traditional ROI (Return on Investment), they must now also consider Return on Integrity.
Integrity comes in many forms. Honesty. Virtue. Morality. But it also means (in more common parlance) “doing the right thing.” It means not waiting to be told to do it or waiting to see what others do first. Integrity means being principled and, as my father used to say, “A principle doesn’t count until it hurts.”
For there to be Return on Integrity, integrity must first be demonstrated – publically demonstrated with names attached. This is especially true in the age of social media where the public is watching and commenting. And nature abhors a vacuum.
The FDA’s “Correcting Independent Third-Party Misinformation” presents an opportunity.
If a firm voluntarily corrects misinformation in a truthful and non-misleading manner and as described in this draft guidance, FDA does not intend to object if the corrective information voluntarily provided by the firm does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising, if any.
This provides industry with a tailor-made opportunity to demonstrate integrity at little or no risk – by correcting the mistakes of others about their products in a transparent and appropriate manner.
Who will step up to the plate? Who will be first? Who will earn the return on integrity? Good guidance has been provided. Now it’s time for industry to do the right thing.
And internalizing the difference between digital marketing and social media communications is a good place to start. It’s time for pharma to cross the social media Maginot Line.
