18 October 2009
Social Media Regulation-Today's Issue Du Jour and Other Viciously Redundant Cycles
10/23/09 22:35 Filed in: 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
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
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New Warning Letter from DDMAC
10/23/09 09:11 Filed in: FDA Enforcement
FDA issued a warning letter to King Pharmaceuticals for a Video News Release (VNR) for their extended release opioid EMBEDA. It was posted on FDA's website yesterday. The letter is interesting for a number of reasons:
FDA's concerns about EMBEDA in the warning letter stem from both the omission of the acknowledgment of the potential for fatality related to the risks and to the fact that the materials promote the uniqueness of the product formulation that is designed to reduce the abuse potential for this opioid. According to FDA, this formulation is designed to reduce abuse potential it has not been shown (by substantial evidence) to reduce abuse potential. The other important note is that FDA continues to be concerned about risk communication in any type of promotional material and in any type of media. In this case, it was not so much the media but the content of the message itself that FDA had a problem with. With respect to the media, it is only interesting in that FDA made no exceptions as to the message regardless of whether it was a VNR or press material as opposed to typical promotional material. This is not a new way of thinking for FDA, but its always interesting to point these issues out when they arise. Also, as I cover information about FDA enforcement actions, its always worth noting that FDA's perspectives and telling of the facts were all that was available to me.
- The opioid class is subject of an unprecedented class wide mandatory REMS due to the significant risks of extended release opioid use including risks of abuse and diversion. Products in this class are an ongoing concern for FDA and DDMAC, because of the obvious public health concerns. FDA has issued multiple warning letters on products in this class over the years, mostly due to concerns of omitting or minimizing risks of opioids. Most noteworthy are FDA's warning letters for Oxycontin which ultimately resulted in a large settlement with the DOJ and state Attorneys General in cooperation with FDA a few years ago. Its interesting that FDA emphasizes the REMS in the warning letter to highlight its concerns about the safety communications for EMBEDA. The proposed FDA REMS includes typical REMS components, a communication plan and elements to ensure safe use that specifically concern the information that is allegedly omitted or minimized in the VNR that was cited.
- According to the letter, there were prior discussions between the company and FDA, in which the company apparently agreed to take corrective action on the material, yet FDA still issued the warning letter to the company. FDA sometimes exercises discretion and witholds issuing warning letters where companies cooperate in taking correcting action proactively. Nonetheless, once the information is disseminated FDA can issue enforcement regardless of the level of cooperation of the company. Where these concerns are of a public health nature, FDA is possibly less likely to exercise favorable discretion.
- The subject of the enforcement action is a video news release. An ongoing issue with the press materials, including press releases and video news releases, is whether or not they are promotional materials (and subject to FDA's promotional regulations) or they are non-promotional in nature and disseminated under 21 CFR 312.7, a provision under the IND regulations that allows for non-commercializing communications about prescription drugs in which FDA will not exercise its authority over promotional materials and advertising. There are additional arguments that such materials deserve some special 1st Amendment protections or are required under SEC disclosure requirements (and consequently should not be considered promotional). However, there's plenty of precedent for FDA enforcement in press materials, particulary where FDA considers these to be false or misleading in any way. The fact that material is meant for press or media purposes is a trivial obstacle (if any at all) where FDA finds an item to be false or misleading and/or where FDA considers the item to raise public health concerns.
FDA's concerns about EMBEDA in the warning letter stem from both the omission of the acknowledgment of the potential for fatality related to the risks and to the fact that the materials promote the uniqueness of the product formulation that is designed to reduce the abuse potential for this opioid. According to FDA, this formulation is designed to reduce abuse potential it has not been shown (by substantial evidence) to reduce abuse potential. The other important note is that FDA continues to be concerned about risk communication in any type of promotional material and in any type of media. In this case, it was not so much the media but the content of the message itself that FDA had a problem with. With respect to the media, it is only interesting in that FDA made no exceptions as to the message regardless of whether it was a VNR or press material as opposed to typical promotional material. This is not a new way of thinking for FDA, but its always interesting to point these issues out when they arise. Also, as I cover information about FDA enforcement actions, its always worth noting that FDA's perspectives and telling of the facts were all that was available to me.