Social Media Regulation, FDA Public Meeting, DDMAC
Guidance
How "influential" Do You Really Want to Be In Social Media?
11/05/09 16:41
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:
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
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
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