While you are trying to steer around the multiple points of view about last week's FDA hearing and FDA's approach to regulating drug, biologic, and medical device promotion on the internet and in social media, below are some (mostly) indisputable facts you need to know. If you grasp the points below, you can save yourself a lot of wheel spinning.

Start here:

1. FDA will likely issue a draft guidance document following the comment period for the public hearing.

2. The ultimate draft guidance will have its own process and comment period, which will in all likelihood come well after the close of the public hearing comment period.

3. Once FDA collects comments after the comment period for any future draft guidance, it will then consider them and work on a final guidance.

4. The draft guidance will likely be able to be followed by industry even if it isn't final, because it represents FDA's current thinking, even in draft. Industry will have to follow the final guidance once finalized.

5. Any guidance document will CLARIFY how FDA believes FDA laws and regulations apply to the internet and social media. It will not CHANGE regulatory requirements. The latter would require either Congress to enact a new law or amend the Food, Drug and Cosmetic Act or would require FDA to issue a new regulation through its rulemaking procedures. The rulemaking procedures are much more burdensome and would take a much longer time than issuing a guidance. Comments and proposals should keep in mind whether or not a proposal would require a CHANGE of regulation or a CLARIFICATION of how existing regulations apply to internet and social media. All good ideas should be communicated, but should first be communicated with a goal of clarifying how they're allowable under current regulations. Only laws and regulations are legally enforceable. Guidance documents clarify how legally enforceable laws and regulations will be enforced.

6. FDA did state in its Strategic Plan on Risk Communication that certain aspects of its promotional regulations needed modernization, so there is in fact a potential for an update to regulations that would impact internet and social media promotion. (See Policy Strategy 4). Both a Guidance and new Regulations are conceivable in the coming years.

7. FDA's risk communication initiatives, steered mostly by the Commissioners office and not DDMAC, will also have a major impact on FDA's guidance, particularly around how the internet handles risk communications as well has how risk communications are perceived by the public. Integrating these two initiatives adds another wrinkle in the ability for FDA to finalize policy. Ultimately, expect some double standards in terms of what FDA can do and what industry can do.

9. Risk communication, minimization of risk, or omission of risk is FDA's most frequently cited violation for ALL media, print, broadcast, or internet.

10. At all times, any internet or social media strategy must be strategizing for outcomes that are legal, scientifically substantiated, and medically responsible, regardless of the current state of any FDA guidance. FDA, the Department of Justice, Plaintiffs lawyers and perhaps company employees/potential whistleblowers will look far deeper than what you tweeted or put on your Facebook page to see if you had any intentions to do something that was illegal. This will focus on the outcome you were trying to achieve far more so than what media you used to achieve it. So, if you are documenting social media or internet communication strategies, make sure the claims and perceptions you are trying to communicate are actually legal in addition to the methods used to get them out.

Bonus Point: The biggest and most difficult issue facing FDA and any regulatory, medical, and legal review committee at any company is the substantiation of claims. It is not the internet or social media. Whether or not a claim is presented in a way that is not misleading and is supported by FDA's substantial evidence standard is the most difficult and time-consuming issue. Claims in any media, including social media or the internet, must be truthful and substantiated on their face and be presented and stated in a way that is not misleading. When FDA says that "Its the message, not the media" this is what they're talking about.

Good luck.

John Murray

Tags: social media regulationFDA Regulation of Social Media, DDMAC Enforcement

Now that FDA's Public Hearing on Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools is over, Regulationships.com would like to take this opportunity to announce its first and only Most Important Presentation Award. I thought long and hard about this (or at least as long as my Acela ride back to Philadelphia). It was a hard choice among a lot of great presentations from a host of diverse people interested in FDA regulation.

It would be too easy to dismiss the roles of persons involved in social media regulation, because they are not in a regulatory or legal role. At this week's FDA public meeting on regulation of the internet and social media, the substantial majority of speaker participants could be classified as "service providers." These are people who are providing services to the companies that are directly regulated by FDA, but these are not the people or companies who are directly regulated. This does not mean they are not directly affected by FDA's regulatory policies. Far from it. Many of the service providers are online marketing and communication agencies, ad agencies (or both), or a variety of companies providing portals or communities for which manufacturer participation (and sponsorship) is far lower than its potential. My point is, that everyone has a voice in FDA's guidance making process, and for the most part, everyone represented the collective interests of the regulated very well.

But today, I'm going to tell you who's participation was perhaps most noteworthy, and it might make you scratch your head.

First, understand that the public hearing, while important and impactful to FDA, is only a scratch in the dent of progress. FDA repeatedly reiterated that all parties should post their comments to the official docket by February 28, 2010. A lot of details sailed passed FDA's ears during the November 12 and 13 hearing. Many good thoughts and ideas dissipated into the ether, but that is ok and to some extent it is by design. The formal commenting process is designed to ensure that the full range of comments are captured and documented through official submissions to the docket. FDA's public hearing serves its greatest value in giving a vivid impression of the issues and tasks at hand. I think clearly that FDA was impacted positively in the need to modernize its regulation and policy and even its overall mentality.

The First and Only Ever Award for Most Important Presentation at FDA's Public Meeting on the Internet and Social Media
This all brings me to my winner for the most important presentation of the meeting. That distinction goes to none other than John Mack, aka Pharmaguy, and owner and author of the Pharmamarketing Blog. As a regulatory and compliance person trained in the art of formality and decorum in regulatory issues and proceedings, I am inclined toward the unqualified reverence of participants, much the way I expect the FDA panel is. John Mack, on the other hand, stood for the authenticity of the issue of social media regulation. Although substantive and largely respectful, John was unbound by the decorum someone like me would have been chained to. I could see FDA squirm as John's slides showed images of John's blog character "FDA Intern" and then on day two, John's fictitious pitch for the Social Media Hearing t-shirts. Heck, I squirmed myself. I said to myself, "John don't, it's just not necessary." The impressions of the "FDA Intern" cartoon and the fictitious pitch to sell t-shirts perhaps made the biggest impression on the FDA panel as they tried to stay as stone faced as possible. But in and among these images or slides, John did present survey data (albeit as John himself pointed out "non-scientific" survey data). The data are every bit as interesting as other data presented that day, because it represented a less formal but "rank and file" perspective on industry issues in social and internet media. But lets get something straight. Most data on internet behavior is exploratory behavioral research--certainly not of the precision, conclusiveness, and generalizability of the studies that FDA requires for conclusions of efficacy and safety about drugs. As far as I'm concerned, it is all anecdotal research. Some is a bit more relevant to certain issues, but its conclusiveness and generalizability beyond the sample studied is questionable, at least under FDA standards. FDA considers most of these types of surveys to be pseudo science when applied to actual medicine and product efficacy and safety. [In spite of its perceived confirmatory or inferential quality, there was indeed a stunning collection of research presented that I believe will ultimately be the biggest catalyst for changing policy, but more on that in later posts.]

Representing the Untidy World of Social Media and, Ultimately, Its Regulation
The most important reason that I think John Mack's presentation was most noteworthy relates to what it represents. For all the formality, reverence, and structure of public health policy making, no one can escape the cold hard reality that regulatory policy making is an inanimate set of rules and principles that are applied to the animate and living world. The application of rules and principles to the animated and "real" world of medicine and medical communication is "messy." That's right, its a mess. It's unpredictable and all at once triumphant and tragic. It's full of despair, promise, elation, happiness, apprehension, and the miracle of life given meaning by the stark juxtaposition of the sadness and inevitability of sickness and death. Most of what I saw at FDA's public meeting was a highly professional and thoughtful collection of constructive thoughts and ideas, but I've been in this business too long to know that this isn't the everyday world of healthcare commercialization and communication. In reality, there are way more moving parts and vastly divergent pressures, incentives, issues and intentions. It is, perhaps at best, a reflection of the everyday world of public hearings.

What John Mack's presentations represented for me was that we need to be reminded of how medicine makes us squirm. It's no comfort zone and what you think and the way you go about things can only be planned and sterilized so much. In drug advertising and promotion we depict benefits but disclose risks. Even in the most legal and informative piece of FDA-compliant communication, companies don't depict the blood-stained floors or emergency rooms, or getting headaches, or sitting on the toilet with diarrhea even though these might be serious or common side effects disclosed in the advertisement. What is depicted are people living their lives, not too well and not too unwell, presumably due to the drug or medical product being advertised. Neither the risks or the benefits portrayed provide a full range of the relevant medical issues (either positive or negative). Regulatory medicine is not real medicine and even the everyday world of drug regulation bears only a slight resemblance even to sterile atmosphere of the public hearing. Having said this, I also want to acknowledge Diane Zuckerman, patient advocate Kim Witczak as well as Alan Coukell whose organization petitioned FDA for a hearing just like this way back in December 2008 (before FDA created a stir by issuing 14 letters on sponsored links). They also are distinguishable in another way. They authentically represent people who who don't have a commercial interest FDA's regulatory policy. I was actually more surprised that there wasn't more representation from commercially disinterested parties.

But, getting back to John Mack, the challenge to our formal sensibilities from his FDA Intern and T-shirt slides were perhaps a bit more unexpected. I do think John has and will continue to have an important voice in pharma marketing issues. I don't agree with everything John says, I don't agree with all the ways in which John communicates on the issues, and I can't promise you that I won't fry him in one of my own blog posts sometime in the future. In fact, I took exception to some of John's survey data (or at least how the results were presented). But, nonetheless, John represented an authenticity that no other speaker represented, at least from a pharma marketing perspective (Diane Zuckerman, Alan Coukell, and Kim Witczak excluded). We need to be reminded that policy making should not be frozen by fears of unintended outcomes or consequences and that policy making and enforcement takes a human and flexible approach to reacting to the real, beautiful, grotesque, irrational and unpredictable world.

John Mack Best Represented the Complexity of a Regulationship
John Mack best represented what a "Regulationship" is--an unwieldy, somewhat unregimented, unorthodox, valuable and inevitable continuum of relationships between people, places, and things impacted by regulation and policy. An attempt to fit the unorthodox and unpredictable into an orthodoxy. John Mack, the "concerned party," blogger, tweeter, critic, advocate and satirist is a player on the regulatory policy field of social media. The crux of regulatory and business issues in social media is the organic nature where everyone is a potential participant and stakeholder. Here, John Mack is a player on a field where FDA and industry doesn't get to decide who plays. This is the very embodiment of the challenge of social media regulation. We don't get to decide who is a player in the social media world when you begin a multidirectional communication. FDA then has to figure out if and how do regulate communication in each direction. Who has what regulationship to what? How does that regulationship determine regulation?

Congratulations, John Mack. Unfortunately, you don't get any tangible reward for this distinction, other than my current respect for what that's worth.

Tags: social media regulationSocial Media Regulation, FDA Public Meeting, DDMAC Guidance

Someday, I guarantee it, some drug, biologic, or medical device company is going to be under a major government investigation for violating FDA's promotional and advertising regulations for its social media campaign. Really. I guarantee it. It makes no difference whether or not FDA issues guidelines on social media or not. Companies can all construct a website, a tweet, a chat room, a Facebook account, a blog with real-time commenting and they can do it in full compliance with any guidance or regulation that FDA ultimately issues. Nonetheless, there will be an investigation into whether or not a company used a social media campaign or strategy to promote its product off-label or in a false or misleading way (and thereby misbranding the product under the Food, Drug, and Cosmetic Act), and there will probably be some form of settlement--meaning, a company will plead guilty to an FDA misbranding allegation in some way or another to using its social media campaign (perhaps in combination with other marketing tactics). It will happen. Mail it in. Fears of off-label promotion in social media and the web 2.0 environment are no "red herrings." They're more like a red whale or a giant red squid with lots of tenacles.

John, why would you say such a thing?

Well, honestly, I'm not really that smart or clairvoyant. It's like predicting rain this spring even though I have an umbrella and a raincoat. I have cover, but it don't mean it ain't gonna rain and I ain't gonna get wet.

But if you really want to know why, then you'll have to read all those paragraphs below. I know that blog posts should be short and easy to read and so on. But, this issue is complex. If you read a blog post on this issue that gives you the three-paragraph treatment, it's assuming you don't need to know anything about a fundamental reason that drug and device social media campaigns are so tedious and precarious, or the writer doesn't think you're interested enough or smart enough to understand. I don't think it's really that complicated so go ahead and read this. It shouldn't take more than five or ten minutes. If you still don't wanna know why, then you probably already know, or you don't want to know or perhaps you're a service provider or agency and you're under the delusion that such an investigation will only affect the regulatory people or the legal department at the drug company and won't affect you. That's fine, you can go ahead and move on. People.com probably has an awesome story about Brad and Angelina that's easier to read and way more fun. You can also skip all the boring details that are essential to your social media campaign's viability in the sections below and go all the way down to the section "If You Skipped Everything Else, Resume Reading Here Where I Continue to Explain that Major Regulatory And Legal Issues are Inevitable."

FDA Policy and the Chain of Influence
In examining the core issues of social media regulation, perhaps the most challenging issue is defining what content in social media a drug, biologic, or medical device company is actually responsible for. This is particularly true for two-way social media communications and "user generated content" such as blog or website comments or other forms of content, stories, endorsements or testimonials by persons not classically employed by or acting by or on behalf of a manufacturer. The line of responsibility is classically drawn where there is an element of compensation between the manufacturer and the speaker, or content provider. FDA has traditionally considered persons acting by or on behalf of manufacturers to be persons like:

• Employees
• Vendors like Ad Agencies, Public Relations Agencies, Medical Education companies, etc.
• Consultants and Advisors (including healthcare professionals, consumers, policy advisors and other experts)
• Investigators, Clinical Research Organizations, and other contract clinical research personnel
• Persons providing paid endorsements (including celebrities, patients or HCPs)
• Anyone else being influenced to speak or communicate about a company's products or services based upon compensation from the manufacturer or its agents.

The FTC's Perspective
The Federal Trade Commission's new guidelines for testimonials and endorsements draws this line primarily between relationships related to compensation and those that are not. Specifically, the FTC seems to hold "sponsored" messages by third parties to be subject to FTC's requirements. Sponsorship is determined (essentially) by various forms of compensation or exchanges of value between the manufacturer/advertiser/sponsor and the speaker/endorser. Traditionally and presumably, compensation can come in a number of direct and indirect forms including: salaries, fees of any sort (including but not limited to consulting fees), free goods or services, discounts, coupons, rebates, and virtually anything else of quantifiable value leading to a real or perceived "this for that" relationship. The FTC's guidelines relate primarily to whether or not a particular communication can be defined as an endorsement or a testimonial. FDA has also always examined compensatory relationships in defining manufacturer responsibility, but FDA examines a more broad construct of influence . Because of this, manufacturers of FDA-regulated products should examine not only communications that could be defined under FTC terms as endorsements or testimonials due to a determination of "sponsorship," but also communications under some other difficult-to-define quality of "influence." Lets call this latter category commercially attributable communications or CACs.

FDA's Perspective Implies that Influence is not Limited to Financial Relationships or Financial Dependence
A closer look at FDA's enforcement approach over the years relates to its assessment of liabilities for misbranding violations under the Food, Drug, and Cosmetic Act and it's implementing regulations, and FDA's approach appears somewhat broader than whether or not there is a financial relationship between an otherwise "third party" and the manufacturer or its agents. There are essentially two ways that companies typically violate FDA's regulations through marketing or promotion and they are: 1) by promoting a product for an unapproved use or 2) by promoting an FDA approved drug or device in a false or misleading way. These are examples of "misbranding." Virtually all of FDA's warning letters to drug, biologic, and device companies about their advertising and promotion are "misbranding" violations. Most of the recent large drug and device company settlements with the US Department of Justice that continue to set fraud settlement records are based on "misbranding" due to off-label and/or false or misleading promotion.

Somewhat dissimilar to how the FTC looks at company responsibility, FDA looks at the much broader concept of "influence" and whether communications of a certain level of commercial influence are attributable to a manufacturer, and thus causing certain responsibilities. FDA's modern concept of influence stems back to its Guidance document relating to Industry Support of Independent Medical Education. The final 1997 guidance document (that is still in effect today) articulates how FDA determines whether or not a drug manufacturer influenced an otherwise "independent" Continuing Medical Education (CME) program and it explains many factors upon which a manufacturer caused a CME program to be dependent or non-independent of a commercial interest or drug manufacturer. This is critically important, because those programs that are not independent are then considered to be "promotional" and subject to FDA's labeling and advertising regulations which prohibit off-label promotion and false or misleading representations, require substantial evidence for efficacy and safety claims and inclusion of fair balance and any relevant material disclosures, among other things.

Improperly Influenced Third-party Programs Are Usually Illegal in Some Way
CME programs invariably fail to meet FDA's promotional requirements, because they are not constructed to meet these on the (sometimes erroneous) premise that they are independent, when in fact they are under the influence of a commercial interest. In a similar way, user-generated content in social media that is purportedly independent of a manufacturer's influence will also invariably fail to meet FDA's regulatory requirements for advertising and promotional materials. "Users" and ordinary citizens participating in social media do not contemplate FDA regulations when posting content on the web or other place, nor do they have to expertise and knowledge to comply with FDA regulations even if they did contemplated them. It's important to understand that just because something is considered to be sponsored (and potentially an endorsement) or influenced, that it's not necessarily illegal, but subject to FTC or FDA requirements. Sponsorship and influence are not illegal, but if sponsorship and influence on third-party content is not disclosed or is purposely concealed, then that failure to disclose or attempt to conceal the influence will be considered to be deceptive. If, in addition to the deception, the content does not comply with all of FDA's requirements, then it will be a violation of the Food, Drug, and Cosmetic act. It will be both a fraud due to the deception and a case of misbranding due to the FDA violation.

In FDA's CME guidance, it provides a laundry list of 12 factors that FDA considers in examining whether manufacturers improperly "influenced" the conduct and content of an otherwise independent educational program, causing FDA to hold a manufacturer responsible for the content of the program. FDA's determinations of "influence" include, but are not limited to, definable financial relationships or financial dependence. Furthermore, FDA explains that this list is not an "exhaustive" list. Also, FDA's factors in this guidance relate specifically to the uniqueness of typical CME programming and most are not directly applicable to social media. However, the conceptual thinking and approach to determining influence could ultimately be very similar. In FDA's CME Guidance, it states specifically that:

"In determining whether an activity is independent of the substantive influence of a company, the agency examines whether and to what extent the company is in a position to influence the presentation of information related to its product or otherwise transform an ostensibly independent program into a promotional vehicle. FDA is concerned that companies may influence the content of educational programs, both directly or indirectly."

FDA's Notice on Its Internet and Social Media Hearing Implies that it is Thinking Broadly About Influence
When we look at FDA's Federal Register Notice announcing the public meeting on electronic and social media, FDA pointedly asks for comments relating to the determination of company influence and responsibility for social media content. FDA remarks specifically:

"...the agency considers whether the manufacturer, packer, or distributor or anyone acting on behalf of the manufacturer, packer, or distributor is influencing or controlling the promotional activity or communication in whole or in part."

"...Manufacturers, packers, and distributors may have a variety of options for how much control they exert over activities on the Internet, regardless of whether the promotional activity occurs on company-sponsored venues or on third-party venues...."

"...In addition, various Web sites and tools can allow manufacturers, packers, or distributors to prompt others to communicate about their products..."

"...With regard to the potential for company communications to be altered by third parties, what is the experience to date with respect to the unauthorized dissemination of modified product information (originally created by a company) by non-company users of the Internet?..."

In FDA's questions, consistent with its prior analysis on company influence on medical education programs, the agency is not limited to analyzing a company's liability for third-party communications based on compensation or some form financial exchange or tangible value other than information. It appears to be exploring specifically, whether a company is in a position to influence the content in some way. I believe, as other's also do, that it is impossible and unreasonable to draw a distinct line of influence between companies and the universe of third party participants in internet and social media communication, particularly given the pervasiveness of enabling technology available to the ordinary internet user. Both John Kamp and Arnie Friede have done a nice job of articulating this issue in a regulatory and legal context. In fact, what is commercial speech and advertising anyway? It is invariably and inherently influential on the knowledge and behavior of its audience. A company cannot possibly be held responsible for every level of third party conduct and communication that is loosely or even directly related to a perfectly legal advertisement or commercial communication. This issue is not only related to social media, it's related to any media.

Nonetheless, FDA persists in probing the issue of "influence" more broadly than one might expect. And, they have good reason to.


If You Skipped Everything Else, Resume Reading Here Where I Continue to Explain that Major Regulatory And Legal Issues are Inevitable
FDA may ultimately provide a guideline on this topic similar to how it did with company support of continuing medical education. Companies can review and approve programs that follow this guidance. The government will have a hard time then, in articulating cases against companies for violation of FDA laws or regulations for third party communications. It will indeed be hard for the Department of Justice or FDA to make such a case. But, that doesn't matter, because in some companies that aren't paying attention, they'll draw up the case for the government so they won't have to do it themselves and they'll do it with elegant detail.

Here's how. The pressure to metric a strategy or campaign too often relies solely or heavily on some perceived need to measure the financial gain or ROI. This leads to an unfortunate perception, usually after the fact, by FDA, DOJ or other investigators, that marketing strategies are engineered with spotless precision and efficacy to mint money and profits. Anyone who knows any better knows better. But the strategy document is then combined with any disparate facts and evidence available to tell the unfortunate story of how a company used a campaign successfully for the company's financial gain. The people responsible for the strategy also often add to this perception by selling and embellishing the success so they get rewarded with a promotion, a bonus, or another contract or project. Social media and internet campaigns are even more unique, because there is an infinite amount of direct and circumstantial data that can be used. Companies are rapidly developing market research techniques to measure the presence or messaging present on the internet in an attempt to harness and decipher all of the available online data, call it social media analytics. I'm skeptical as to their true precision or accuracy, but I'm sure someone will use these data to sell programs or to show companies what buttons to push for the success of whatever strategy.

This is why I guarantee that there will be a major FDA misbranding case and investigation into a drug manufacturer's marketing due to social or internet media campaigns. Another reason, is that the nature of internet and social media and "viral" campaigns enables these to be set in motion by a company, but both unintended and intended outcomes can become uncontrollable in either a positive or negative way. And it can happen fast. Even if a company has good intentions, the simple perception that a bad "viral" message was set in motion by a company will at least lead to the charge that a company was negligent, if not intentional, in some way and should have known better. So there you have it. That's why I think social media will lead to a major FDA misbranding investigation and settlement, even if FDA issues clear guidance. New media techniques are still uncharted territory where phenomena spread like "viruses" through word of mouth, word of keyboard or mobile smart phones. But, this should not keep FDA from issuing guidance any more than it would ever keep FDA from issuing any guidance or regulation. All laws, regulations, or guidances will be violated in some way eventually, otherwise you wouldn't need enforcement agencies. What's important is that FDA makes good policy that can be interpreted by companies and the public along with FDA.

Why Social Media Campaigns Are Actually OK And What You Can Do to Make Sure They Are Ok (for the most part)
Ok, so that's all the bad news. Companies will and should engage in social media and web 2.0 and web 3.0 campaigns. I'm not advocating for a freeze in progress. I'm just shedding light on an inevitable error in the system. I'm a compliance person. Compliance programs need to anticipate errors, and then put systems into place to avoid them (if they know what they're going to be) or to detect them (cause they know they're going to happen). A good compliance program will control errors, detect them when they occur and fix them before they become systematic or out of control.

The most important thing for anyone engaging in any type of new media campaign is to define and document the outcomes that the campaign is trying to achieve and doing it right from the very beginning even during the conceptual thinking. Then a company needs to map out how it will legally achieve that outcome and stick with the plan. When I say "do it right," I mean forget about everything you've ever thought about being "aggressive" and seeing what gets through regulatory and legal. Some bells you cannot un-ring, and when you are conceiving of or reviewing any campaign you must define what outcome you are trying to achieve and take time to make sure it is achievable within FDA regulations; and that is consistent with a product's labeling and the substantial evidence supporting the product's effectiveness and safety. FDA and the government will use its theories on a company's "intended use" based on its theory of a company's "objective intent" and examine virtually any piece of company evidence to make its case. What's that? You're not a regulatory expert so you don't know what's ok and what isn't? Ok, then get your regulatory, legal and medical people involved from the beginning and it's never too early. You need to work with these people to ensure that your "objective intent" is compliant with FDA's regulations from the get go and to ensure all of your documents, including proposals, strategies, emails, slide presentations, etc etc, tell a good story about what you planned and executed.

Here are some questions you should ask yourself when beginning a social media strategy. I can't explain them all here in great detail. I'm surprised you're still reading anyway. But these are some basic things you need to think about at the very beginning and throughout your planning and execution. If you don't know how to answer them, talk to your regulatory and legal people.

Is there a financial or compensatory relationship between the manufacturer or its agents and the source of the communication or content?

Is there a social media strategy designed to cause secondary messaging that is false or misleading or off-label?

Are all social media and traditional media promotional messages compliant with FDA's promotional labeling regulations?

If manufacturer content has been restated or repurposed by a third party, was this encouraged by the manufacturer or enabled by design?

Like I said earlier. I can see into the future, but it isn't anything mystical. The fears of off-label or false or misleading promotion are not red herrings. Calling something a red herring is an old tactic that people use to discredit real issues that they can't solve or don't understand. Nonetheless, I can also see that the power of new media can be engineered for important and positive public health and regulatory outcomes, that are also, in turn, good business outcomes. Also, I believe social media campaigns will become essential management tools for regulatory and compliance program issues. Believe me, I think it would be naive and short sighted for FDA to stifle social media with too paternalistic of an approach. While regulatory concerns are certainly not red herrings, they just may be the golden goose who lays the golden compliance egg. Anyway, those ideas are for other posts. Keep working at it.

Regards,

John Murray

Tags: social media regulationSocial Media Regulation, FDA Public Meeting, DDMAC Guidance

You gotta think you're pretty smart if you expect people to read your blog about drug regulation. You gotta think you're really really smart if you expect people to read your blog posts about FDA's regulation of the internet and social media. You also can't take yourself so seriously. It gets pretty tedious and dense and it can get pretty surreal. I've been reading a lot of conjecture from blog to blog and tweet to tweet about the regulatory issues with FDA's Public meeting next week as well, and I'm amazed at the many people engaged with genuine interest in regulatory dialogue. I'm not agreeing with everything that I read or hear. It's easy for me to get defensive or offended when I read or hear one blogger or marketing consultant after another opine on regulatory issues that I've spent nearly my entire adult life navigating. I imagine though, that it's a lot like the way doctors must feel when they see everyone and their mother spewing medical opinions and perspectives all over the internet. What right do ordinary citizens have to converse about medicine and health care?

And then I realize that to feel that way is just stupid. There isn't a more elegant or intellectual term for it.

Why wouldn't people be hyper-concerned about medical issues and actually converse about it the way they converse about it today--web 2.0 style? Isn't that precisely the power and value of medical communication on the web and in social media? And then it occurs to me that this makes all the sense in the world that drug marketers and their business partners and agencies ought to be similarly hyper-concerned about regulatory issues that affect them directly. FDA's "guidance" will set policy for everyone in an extraordinarily profound way. It's nearly impossible to overstate how profound it will be to everyone involved. Even if FDA comes out next year and says "Status Quo everybody, just keep not doing what you're not doing" that is going to have profound impact on medical communication.

As another example, just think about the revolution in healthcare communication that FDA's DTC broadcast advertising guidance led to. That guidance document, drafted in 1997 and finalized in 1999 dealt with one single thing--how to provide the labeling to people who watch a TV ad for a prescription drug (by telephone, website, or concurrent running print ad). That's it. A decade later, DTC advertising is tied to the whipping post of every regulatory, Medicare, and healthcare reform discussions. Lots of money is spent on DTC advertising. Lots. And lots, lots more money is spent on drugs as a result of DTC advertising. If nothing else, people are more aware and engaged in their own medical care today as a result. All this because FDA said you can run a TV ad if you provided access to drug labeling or a brief summary by giving someone a phone number to request it by phone, a website address to get it throught the internet, and the name of a magazine so someone could go read a brief summary in a concurrently running print advertisement. That small revolution is a stepping stone (or boulder) upon which today's medical communications are built.

On the other hand, FDA's upcoming public meeting is asking a bread basket of questions about a lot of different issues. Lord knows where any potential guidance or guidances (plural) will go, but chances are, it will address more than one issue. The influence of any FDA guidance will be extensive, to understate things. So if you're interested in regulatory issues and blogging and conversing and opining, keep it up. If you're speaking at FDA's public meeting next week, represent your industry well--with honesty, principles, concern and reverence for the importance of what you do-and what FDA does and how it all impacts patients and doctors.

Just as every human is the most important player in their own medical care, every medical communicator is the most important player in FDA's regulation of medical communication. As a compliance professional and a regulator, I always have the perspective, that when I give people advice and direction, that advice is more important to my client than it is to me. I'm not engaging in the regulated activity, they are. I make submissions to FDA and I go back to my computer and my telephone and my pile of paper. They go out and actually engage in the communication that FDA is watching and regulating. It's refreshing to see the professional engagement of diverse groups of business people in FDA's meeting on the internet and social media next week.

Next week and forever afterward, keep it professional and principled and reverent to that sacred place where medical decisions are made--where real people make real decisions to use medicine in the hope that it helps and doesn't harm. Avoid cliches and talk the walk and walk the talk. It's a new world, and FDA's regulation of the internet and social media is about what happens when we are talking and how that affects how others talk and then walk.

See you in DC.

Regards,

John Murray

Tags: social media regulationSocial Media Regulation, FDA Public Meeting, DDMAC Guidance

FDA’s upcoming meeting on internet and social media is geared to get public comments on specific issues, among them, FDA is seeking specific comments on whether or not and when it is appropriate for companies to engage in correcting third party information on the internet or in social media. Many websites, including blogs, news sites, and other types of sites include feedback mechanisms or other opportunities to engage the third party such as community forums or chat rooms.

At first, the questions relating to this issue seem to be pretty unremarkable, but when one considers the answers, an almost mystical reality unveils itself. Drug, biologic, and medical device manufacturers have the power to transubstantiate truth by merely uttering or possessing it. Indeed, the truth can be transformed into lies or partial truths when regulated companies communicate words that are virtually identical to words uttered by non-regulated people or organizations. The nature of FDA's question highlights a glaring contradiction in the regulatory definitions of terms like "false" and "misleading." FDA clearly understands that false and misleading information needs to be corrected, but non-commercial speech from people not regulated by FDA (the third parties) is subject to ill-defined criteria for truthfulness. Therefore, it is hard for FDA to identify the types of third-party communications that are in need of correction.

Let’s examine FDA’s request for feedback on whether or not and how companies might engage in correcting third-party misinformation about their FDA-regulated products.

In its Federal Register Notice, FDA states:

"Some manufacturers, packers, or distributors have expressed a desire to correct what are, in their belief, misconceptions or misinformation about their products, including unapproved uses of their products that are being conveyed on a Web site outside their control, … Other companies have stated that they have not corrected what they believe is misinformation in the belief that they could be viewed by such an action as being responsible for all the information on the target Web site rather than just the information that they post or submit.

The agency is interested in any data or research on how companies have approached these issues. Are there any parameters or criteria that could be used to determine the appropriateness of correcting misinformation and/or scope of information a company can provide when trying to correct misinformation on a Web site outside a company's control?

Should the parameters differentiate with regard to the prominence of the third-party site (i.e., readership), its intended audience (e.g., general public, health care professionals, patients), its intended purpose (e.g., personal diary, encyclopedia-type reference), and/or the author of the information on the site?" [emphasis added]

First of all, it is quite remarkable that FDA is asking this question in the first place. It seems to imply that there may be some skepticism as to whether or not there is a bona fide need to engage in corrective communications. Further, FDA in its background to the questions, seems to acknowledge that situations are possible, but does not acknowledge any specific situation in which it might be necessary. It implies that FDA has a vacuum of perspectives on this potential need, which to me is unfathomable.

I would answer FDA’s questions with a series of questions and somewhat pointed, and somewhat fictitious answers.

Question (to FDA): FDA, does the agency ever feel the need to communicate information on the internet in an effort to correct public misperceptions of medical information caused by third parties?
Answer (not really from FDA, but possibly-you’ll get the point): Yes, see Flu.gov and FDA’s and the CDC’s communications on H1N1 vaccine safety, efficacy, and availability. FDA and CDC are engaging in an exemplary campaign of ensuring factual information about H1N1 in the midst of dangerous misinformation and crack pot conspiracy theories. By the way, these communications concern the H1N1 vaccine. Each of these vaccines are FDA-regulated biologic products subject to FDA’s prescription drug advertising and promotional labeling requirements, but we don’t necessarily apply these requirements because we’re not manufacturers. That’s just a contemporary example. We have more examples that are similar. Did you see our social media page, by the way? Check out our Fraudulent H1N1 Products widget below.


Question (to FDA): What basic criteria does FDA use to determine when it needs to communicate corrective information?
Answer (not really from FDA, but possibly-you'll get this point too): Simple. When the existence of bad information from third parties creates a public health concern.

Question (to industry): What criteria would manufacturers use?
Answer (speaking for myself, not any manufacturers or clients): Simple again. Manufacturers could use the lowest possible threshold—The same set of requirements used by FDA and it's advertising enforcement divisions (DDMAC and APLB) for the determination of false or misleading or off-label information. For example, DDMAC frequently considers communications by drug manufacturers to be “raise significant concerns” when communications omit risk information, minimize risk information, make unsubstantiated claims, encourage unsafe or ineffective use of products, or are otherwise violative of FDA regulations. Don’t we all fundamentally agree that false or misleading information should be corrected?

Question (to industry): Do you have any examples of this?
Answer (speaking for myself, not any manufacturers or clients): Do I ever. See FDA’s website. The determination of false or misleading information and enforcement is a significant if not sacred undertaking. FDA uses a number of different criteria with which to determine that advertisements and promotional materials, including websites and other internet communication systems, could be false or misleading to the intended audiences. FDA’s enforcement actions alone are examples of the agency engaging in corrective communications where it has a statutory and public health duty and need to do so.

In many cases, FDA explicitly states that these violations raise concerns or raise public health concerns due to omission or minimization of safety information. As a baseline, the same communications could not possibly be more truthful or less misleading, merely because they are uttered by entities other than drug manufacturers. Therefore, any logical and reasonable person would conclude that there is widespread false and misleading communications on the internet, on the basis alone that unregulated communications about medical products do not comply with FDA’s content requirements imposed on drug manufacturer communications. If any news organization, ordinary citizen, or even government agency sponsors a link on a search engine or issues a 140 character “tweet” on Twitter, and these do not meet all of FDA’s disclosure and substantiation requirements, they are not regulated as false or misleading speech. If a manufacturer utters the same exact information in the same form, it can sit by its fax machine and expect a warning letter from FDA.

Question: That’s a pretty low threshold—then what criteria should FDA consider is appropriate for companies to engage in corrective communications on third party sites or publications?
Answer: It is indeed a pretty low threshold. Honestly, it is not for the agency to decide. A manufacturer should be able to use its own judgment where it sees a specific need to correct third-party communications. Moreover, these corrective actions, if done factually and without omissions, should not be considered to be promotional and subject to mechanical FDA requirements for advertising or promotional materials. Corrective communications should be narrowly tailored to the specific issue, non promotional in tone and presentation, and should contain information material to the corrective response. FDA’s fair balance requirements, labeling requirements, etc., should not be considered inherently material and should recognize the limitations of the media form (e.g., Twitter character limitations if applicable).

Don't Take this the Wrong Way
The forgoing fictitious dialogue is certainly meant to make a point. I emphatically pose to you however, that FDA has an extensive role in regulating company or company-sponsored speech. In some ways it may be taken as sarcasm and I really don’t mean it that way (for the most part). Nonetheless, as I work through this one issue in FDA’s public meeting notice, it’s hard not to see the potential for unreasonable prior restrictions or restraints on companies trying to engage in legitimate activities on the basis of fear and suspicion. By the way, I’m not making a First Amendment argument here either, just an argument about what is simply reasonable and responsible and for FDA to be a bit introspective about the nature of its own policies.

I would also propose that FDA begin to think more clearly about carving out situations and defining particular types of communications that are not advertising or labeling as defined by the Food, Drug, and Cosmetic Act and it's implementing regulations. In fact, I think its pretty clear that the FDA has broad authority to regulate commercial speech, particularly in cases where the speech is misleading or false. But the criteria for which FDA considers information to be misleading based on an overly broad application of advertising and labeling regulations needs to change. FDA suffers from an inability to define manufacturer communications as anything but labeling or advertising. This constrains both FDA and manufacturers in ways that don’t serve the public health.

I’m also not saying that FDA should apply its regulations to all forms of speech or communications. That’s simply ludicrous. I’m only saying that FDA should not impose criteria on manufacturers for correcting third party communications, where there is a legitimate need to do so. FDA should harness the self-interest of manufacturers to help ensure the safe and effective use of medicines and medical products. FDA should consider not only disincentives for false or misleading manufacturer communications (warning letters and misbranding cases), but also positive incentives for truthful, useful, and responsible communications (thoughtful and non-paternalistic guidance).

Medical product regulation is a serious undertaking requiring rational approaches without diminishing FDA’s authority to enforce against communications and conduct that are dangerous or not in the best interest of patients or the public health and welfare. In considering policies, FDA should acknowledge the nature of truth. It is not a function of the possessor or speaker, but of the substance. In answering the question as to what situations or criteria could be used to enable manufacturers attempting to correct false or misleading third-party information, FDA should look at its own roles and impetus for its own actions for perspective.

Regards,

John Murray

Tags: social media regulationFalse and Misleading, FDA Enforcement, Social Media Regulation

In the midst of any number of unprecedented regulatory challenges facing industry today, FDA's issuance of 14 warning letters on search engine sponsored links in March of 2009 set off a whirlwind of activity throughout industry-within drug manufacturers and throughout the vendor community. The letters were an attempt by FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to clarify its position on a select issue (branded sponsored links) and do so with a sweeping and unprecedented 14 simultaneous enforcement actions. It was undoubtedly a calculated and orchestrated affair. If you examine the letters you'll see that most were transmitted at roughly the same time (all by fax between 2 PM and 5 PM March 26, 2009) to the group of unfortunate manufacturers (as if they were done by ceremony or ritual). The letters dealt with a very simple issue--the need to convey fair balance and full indications in advertising and promotion. Regardless of whether the advertisement is text in a sponsored link or whether it is in a full size 8 1/2 by 11 journal page, the requirements appear to be the same. FDA's advertising regulations found in 21 CFR 202.1 culminate in the clear requirement to convey in the body of an ad--a fair balance between information relating to effectiveness and information relating to side effects, contraindications and warnings. Now we can prop up any number of arguments as to the "virtual" presence or accessibility of the required information in the websites found "one click" away. The so called "one click" rule is a fiction and always was. FDA never at any time adopted a "one click" policy, guidance, or anything of the sort. It was a convention subscribed to by industry and its advertisers that over the years became a rule of thumb, but not a real rule. I certainly do question FDA's priorities, and whether these letters and the resources expended as a result of them were all that helpful, but that's another matter.

Tweet Ups and Love Ins
FDA's sweeping enforcement was largely against more traditional web advertising and not "social media." But the actions punctured a blood blister of frustration over the inability for the drug industry to leverage rapidly changing new technology and media. The next thing we know, FDA is having a public meeting on the use of electronic and social media to hear from the public about what it thinks of the technological advances in internet communications and how regulations do or should apply. Keep in mind this is a "public" meeting, not just a meeting to hear from manufacturers and advertising agencies, but to hear from the public which includes critics of FDA's policies and critics of the industry as well. Expect the public to include people who think FDA's enforcement is not restrictive enough on industry's marketing and communications practices in traditional and social media. Presumably, FDA will use the information it gathers from this meeting and comments from the docket to clarify new positions (in official FDA guidance) or reaffirm its current positions. Throughout industry, this has created a very unique and united front of agencies, vendors, consultants and manufacturers themselves in seeking official FDA positions on electronic and social media. As I scan the twittersphere or attend any number of industry meetings, I can't help to notice a certain activism that borders on a 60's protest movement, as if FDA's public meeting is a pilgrimage to Woodstock, a no-nukes concert, or worse, Altamont Speedway.

Officer, What do You Think of My Sports Car that Goes 150 Miles Per Hour?
Having spent 15 years as a regulator in industry, I'm fairly certain that people are going to find disillusionment after all is said and done, in much the same way people become disillusioned by most (but perhaps not all) movements. So far, I've seen quite a bit of talk and I've yet to see or hear of one singular proposal from industry as to what it thinks an FDA policy should be. I see a lot of asking for guidance or clarity or "just to know the rules." I think what people need to understand is that FDA has already articulated rules (explicitly and implicitly through its enforcement) and if you simply go forward asking for clarification or guidance, then they'll turn around and articulate the status quo that everyone is already intensely dissatisfied with. They'll give you the rules you already know in an elegant draft guidance document and then someday later on they'll finalize it. The rules as we fear we already know them will be captured in classic government print. What will follow is a numbing reality that as things change, some things stay the same. You can cook the turkey on a wood fire, bake it in the oven or nuke it in the microwave but its still turkey regardless of the technology used to cook it. It's up to industry to build a better mousetrap and provide an effective regulatory scheme to ensure its integrity and its public health value; along with rules and structures to ensure that it does not pose a threat to or have a negative impact on the public health or the safe and effective use of FDA-regulated products. All product-specific communications emanating from industry social media efforts must not be false or misleading, lack fair balance, or omit material information. What definable and reliable system will ensure that? In order to truly leverage the potential of new technologies, its up to industry to propose it, or wait and hope for a giant overburdened bureaucratic agency to have a miraculous epiphany and innovative flourish. Which do you think is the better option?

Furthermore, over the last six months I've seen people stop just short of begging for FDA to issue guidance on electronic and social media. In so many ways, that's like driving up to a state policeman and asking him what he thinks of your brand new Lamborghini sports car and asking him advice on how to drive it. Of course your sports car has a speedometer that goes up to a very achievable 150 miles per hour. So how do you think law enforcement will respond? Keep in mind, that DDMAC is an enforcement division of FDA. The overwhelming (and I mean OVERwhelming) majority of its interactions with industry concern communications in which it is either a) warning companies that its advertising or promotion is false and misleading or illegal (enforcement actions); or b) that it is advising companies in the ways in which proposed advertising or promotion is false or misleading and potentially illegal (advisory opinions). DDMAC spends the rest of its time surveilling industry communications to find false or misleading advertising and promotion or cooperating with the Justice Department, State Attorneys General, or the FTC in investigating fraudulent promotion and Federal misbranding cases. "Officer, what do you think of my sports car that is capable of going more than twice the highest speed limit of any US interstate? Please consider that it is technological marvel."

I Have Reason to be Cynical
As you can tell, I'm pretty cynical about any liberal or "enabling" guidance from FDA on social media participation by regulated companies (prescription drug and device manufacturers and manufacturers of restricted devices). Trying my best not to seem like a crotchety old regulatory person, I've experienced first hand and lived through enough of how FDA works, (from labeling negotiations to enforcement actions to advisory opinions to advisory committees on through FDA's new-found approaches to drug safety and REMS and its many attempts at policy and guidance making) to know that FDA will be highly cautious and sensitive to any enabling guidance that will unleash criticism of being too "industry friendly" or unintended consequences that will lead to congressional hearings and unflattering GAO reports and so on. Take notice of the new administration's growing list of influential and high level appointments within FDA and notice the purportedly "industry-friendly" Bush appointments being summarily replaced by purportedly "industry unfriendly" Obama administration appointments. That doesn't give me a lot of confidence to expect any permissive FDA guidance.

I've also listened to a lot of dissatisfaction from ad agencies and product management about the walls that continue to close in on drug marketing, whether it's the internet, or safety communications, or policies on gifts, entertainment, business dinners, or any number of industry practices that have changed dramatically as a result of additional government enforcement or voluntary industry guidelines. There's good reason to be frustrated. The toolbox has been turned over and the wrenches and screwdrivers have been dumped out. On top of that, new-fangled innovative and useful power tools are restrained of their utility out of fear of their power. Perfectly useful and legitimate communication tools are rendered dangerous simply because they are in the hands of drug manufacturers. The same tools in the hands of teenagers, entertainers, patients, health plans, and even the government itself are instruments of progress and even necessity. Put that new-fangled hammer in the hands of a drug manufacturer and the tool is treated like a weapon by regulators rather than a tool.

Now that you're all riled up, let me tell you that's the way it ought to be.

The hurdles for drug manufacturers that profit from healthcare products should be high in a just society. Prescription products are available only by prescription for many reasons. Prescription medicine is powerful medicine requiring delicate consideration by qualified practitioners adequately apprised of the substantial efficacy and safety of the product and who prescribe the medicine to patients in an informed and consensual environment. Drug marketing itself has become perhaps more sophisticated than medicine itself in many ways and the risks of trivializing medical decisions from the advice of 140 character tweets, blogs, chats, text messages, or medical advice via word of mouth from the mouths of unqualified people should bear heavily on the minds of FDA and the FTC.

I Have Reason to be Hopeful

Now that you're all defensive, let me tell you that you shouldn't be.

First of all, the drug industry accepts that it has a higher hurdle than the general public or other industries. We live with it everyday, and all things considered, we function pretty well. Of course we have Lamborghinis, but we have minivans and Priuses too. Manufacturers are going through tough times with high turnover and layoffs, increased regulation on all fronts, pivotal changes in business models, and a clear desire for more change. So, while industry tries to innovate its marketing and communication practices and to be more "truly" patient focused, drug regulation stands in the way of any true progress. Communication requirements that are nearly a half a century old are being applied to new technologies and techniques. FDA knows this, the Obama administration knows this, and FDA has asked to hear from the public about its regulation of new technology and media. FDA also knows that industry has a history of aggressive marketing, and in spite of the obsolescence of FDA's advertising and labeling regulations, FDA's Public Meeting Notice begins with the premise that not much needs to be changed, but asks for suggestions for how certain things can be addressed in electronic and social media. FDA is not willing to give much ground up, and it doesn't have much incentive to.

It's up to industry to propose new models of communication that should be enabled and encouraged by regulation rather than restricted. It's up to industry to disrupt FDA's premise that its current regulations are sufficient to regulate most new and electronic media, and it's up to industry to do it in a positive way. As you prepare to participate in the Public meeting or to provide comments to the docket (through February 28, 2010), ask yourself "what types of communication strategies are a true missed opportunity for the enhancement of medicine or the public health as a result of regulatory restrictions?" In an ideal world, how could I help patients understand medicine and medical decisions? In what ways, are these possibilities restricted by regulation? If I could do the ideal, how should it be restricted or regulated to avoid abuse?

Regulations are designed to promote truthful and non-misleading drug communications. Just because they are designed for this purpose, it doesn't mean they promote or ensure useful or optimal communication. Innovations in medical communication are highly unlikely to come from a giant, overburdened, bureaucratic federal agency through its process of policy or guidance development. At best, regulatory schemes should be flexible enough not to stifle progress, but asking for or expecting FDA's guidance documents to be an impetus for innovation is misguided. FDA guidance may lead to proliferation of communications that comply with its guidance. Not much more. Proliferation is not innovation. They're two different things.

Please also keep in mind that FDA's mid-November public meeting is only a single event in a process. The comment period for FDA's notice ends in February next year. Pay attention to the public meeting, but also prepare your best ideas within the timeframe. Don't unleash half-baked ideas if you don't have to. Inform your ideas from the public meeting and don't stop trying to innovate even after the comment period or potential guidance making. There are many legitimate ways to continue to influence policies and practices in favor of good ideas.

Be Realistic, But Don't Be Hopeless...

...and be hopeful, but don't be unrealistic.

Regards,

John Murray

Tags: social media regulationFDA Regulation of Social Media, DDMAC Enforcement