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Complete abridged guide to FDA social media Guidance and regulation

John@GrayscaleCompliance.com — 2009-11-18T07:32:08-05:00

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. ...FDA will likely issue a draft guidance document following the comment period for the public hearing. ...The ultimate draft guidance will have its own process and comment period, which will in all likelihood come well after the close of the public hearing comment period. ...Once FDA collects comments after the comment period for any future draft guidance, it will then consider them and work on a final guidance. ...The draft guidance will likely be able to be followed by industry even if it isn't final, because it represents FDA's current thinking, even in draft.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. ...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. ...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. ...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. ...Risk communication, minimization of risk, or omission of risk is FDA's most frequently cited violation for ALL media, print, broadcast, or internet. ...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.

The First and Only Regulationships FDA Social Media Public Meeting Award Goes to.....

John@GrayscaleCompliance.com — 2009-11-13T14:36:02-05:00

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. ...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. ... 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. ...The First and Only Ever Award for Most Important Presentation at FDA's Public Meeting on the Internet and Social Media ...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. ... 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. ... 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. ... 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. ... 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. ... 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. ... [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.] ...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. ... 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. ...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. ... 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. ... 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). ...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 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 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. ... We don't get to decide who is a player in the social media world when you begin a multidirectional communication.

How "influential" Do You Really Want to Be In Social Media?

John@GrayscaleCompliance.com — 2009-11-05T16:41:25-05:00

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. ... 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). ...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. ... 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. ... 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." ...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. ...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. ... 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." ...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. ... 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. ...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. ...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. ... 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. ...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. ..."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. ...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 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. ... 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. ...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. ...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. ...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. ... 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. ...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. ... 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. ... 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.

Talking the Walk in Social Media Regulation

John@GrayscaleCompliance.com — 2009-11-04T21:36:29-05:00

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. ... 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. ...And then I realize that to feel that way is just stupid. ...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). ... A decade later, DTC advertising is tied to the whipping post of every regulatory, Medicare, and healthcare reform discussions. ... 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. ... 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 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. ... 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.

The Magical Transformation of Truth and the Metaphysical Power of Drug, Biologic and Medical Device Manufacturers

John@GrayscaleCompliance.com — 2009-11-01T19:17:19-05:00

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. ...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. ...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. ..."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. ...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?" ...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. ...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. ... 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. ...

H1N1 Fraudulent Products.
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