01 November 2009
The Magical Transformation of Truth and the Metaphysical Power of Drug, Biologic and Medical Device Manufacturers
11/01/09 19:17 Filed in: Social Media
Regulation
FDA’s upcoming meeting on internet
and social media is
geared to get public comments on specific issues,
among them, FDA is seeking specific comments on
whether or not and when it is appropriate for
companies to engage in correcting third party
information on the internet or in social media.
Many websites, including blogs, news sites, and
other types of sites include feedback mechanisms
or other opportunities to engage the third party
such as community forums or chat rooms.
At first, the questions relating to this issue seem to be pretty unremarkable, but when one considers the answers, an almost mystical reality unveils itself. Drug, biologic, and medical device manufacturers have the power to transubstantiate truth by merely uttering or possessing it. Indeed, the truth can be transformed into lies or partial truths when regulated companies communicate words that are virtually identical to words uttered by non-regulated people or organizations. The nature of FDA's question highlights a glaring contradiction in the regulatory definitions of terms like "false" and "misleading." FDA clearly understands that false and misleading information needs to be corrected, but non-commercial speech from people not regulated by FDA (the third parties) is subject to ill-defined criteria for truthfulness. Therefore, it is hard for FDA to identify the types of third-party communications that are in need of correction.
Let’s examine FDA’s request for feedback on whether or not and how companies might engage in correcting third-party misinformation about their FDA-regulated products.
In its Federal Register Notice, FDA states:
First of all, it is quite remarkable that FDA is asking this question in the first place. It seems to imply that there may be some skepticism as to whether or not there is a bona fide need to engage in corrective communications. Further, FDA in its background to the questions, seems to acknowledge that situations are possible, but does not acknowledge any specific situation in which it might be necessary. It implies that FDA has a vacuum of perspectives on this potential need, which to me is unfathomable.
I would answer FDA’s questions with a series of questions and somewhat pointed, and somewhat fictitious answers.
Question (to FDA): FDA, does the agency ever feel the need to communicate information on the internet in an effort to correct public misperceptions of medical information caused by third parties?
Answer (not really from FDA, but possibly-you’ll get the point): Yes, see Flu.gov and FDA’s and the CDC’s communications on H1N1 vaccine safety, efficacy, and availability. FDA and CDC are engaging in an exemplary campaign of ensuring factual information about H1N1 in the midst of dangerous misinformation and crack pot conspiracy theories. By the way, these communications concern the H1N1 vaccine. Each of these vaccines are FDA-regulated biologic products subject to FDA’s prescription drug advertising and promotional labeling requirements, but we don’t necessarily apply these requirements because we’re not manufacturers. That’s just a contemporary example. We have more examples that are similar. Did you see our social media page, by the way? Check out our Fraudulent H1N1 Products widget below.
Question (to FDA): What basic criteria does FDA use to determine when it needs to communicate corrective information?
Answer (not really from FDA, but possibly-you'll get this point too): Simple. When the existence of bad information from third parties creates a public health concern.
Question (to industry): What criteria would manufacturers use?
Answer (speaking for myself, not any manufacturers or clients): Simple again. Manufacturers could use the lowest possible threshold—The same set of requirements used by FDA and it's advertising enforcement divisions (DDMAC and APLB) for the determination of false or misleading or off-label information. For example, DDMAC frequently considers communications by drug manufacturers to be “raise significant concerns” when communications omit risk information, minimize risk information, make unsubstantiated claims, encourage unsafe or ineffective use of products, or are otherwise violative of FDA regulations. Don’t we all fundamentally agree that false or misleading information should be corrected?
Question (to industry): Do you have any examples of this?
Answer (speaking for myself, not any manufacturers or clients): Do I ever. See FDA’s website. The determination of false or misleading information and enforcement is a significant if not sacred undertaking. FDA uses a number of different criteria with which to determine that advertisements and promotional materials, including websites and other internet communication systems, could be false or misleading to the intended audiences. FDA’s enforcement actions alone are examples of the agency engaging in corrective communications where it has a statutory and public health duty and need to do so.
In many cases, FDA explicitly states that these violations raise concerns or raise public health concerns due to omission or minimization of safety information. As a baseline, the same communications could not possibly be more truthful or less misleading, merely because they are uttered by entities other than drug manufacturers. Therefore, any logical and reasonable person would conclude that there is widespread false and misleading communications on the internet, on the basis alone that unregulated communications about medical products do not comply with FDA’s content requirements imposed on drug manufacturer communications. If any news organization, ordinary citizen, or even government agency sponsors a link on a search engine or issues a 140 character “tweet” on Twitter, and these do not meet all of FDA’s disclosure and substantiation requirements, they are not regulated as false or misleading speech. If a manufacturer utters the same exact information in the same form, it can sit by its fax machine and expect a warning letter from FDA.
Question: That’s a pretty low threshold—then what criteria should FDA consider is appropriate for companies to engage in corrective communications on third party sites or publications?
Answer: It is indeed a pretty low threshold. Honestly, it is not for the agency to decide. A manufacturer should be able to use its own judgment where it sees a specific need to correct third-party communications. Moreover, these corrective actions, if done factually and without omissions, should not be considered to be promotional and subject to mechanical FDA requirements for advertising or promotional materials. Corrective communications should be narrowly tailored to the specific issue, non promotional in tone and presentation, and should contain information material to the corrective response. FDA’s fair balance requirements, labeling requirements, etc., should not be considered inherently material and should recognize the limitations of the media form (e.g., Twitter character limitations if applicable).
Don't Take this the Wrong Way
The forgoing fictitious dialogue is certainly meant to make a point. I emphatically pose to you however, that FDA has an extensive role in regulating company or company-sponsored speech. In some ways it may be taken as sarcasm and I really don’t mean it that way (for the most part). Nonetheless, as I work through this one issue in FDA’s public meeting notice, it’s hard not to see the potential for unreasonable prior restrictions or restraints on companies trying to engage in legitimate activities on the basis of fear and suspicion. By the way, I’m not making a First Amendment argument here either, just an argument about what is simply reasonable and responsible and for FDA to be a bit introspective about the nature of its own policies.
I would also propose that FDA begin to think more clearly about carving out situations and defining particular types of communications that are not advertising or labeling as defined by the Food, Drug, and Cosmetic Act and it's implementing regulations. In fact, I think its pretty clear that the FDA has broad authority to regulate commercial speech, particularly in cases where the speech is misleading or false. But the criteria for which FDA considers information to be misleading based on an overly broad application of advertising and labeling regulations needs to change. FDA suffers from an inability to define manufacturer communications as anything but labeling or advertising. This constrains both FDA and manufacturers in ways that don’t serve the public health.
I’m also not saying that FDA should apply its regulations to all forms of speech or communications. That’s simply ludicrous. I’m only saying that FDA should not impose criteria on manufacturers for correcting third party communications, where there is a legitimate need to do so. FDA should harness the self-interest of manufacturers to help ensure the safe and effective use of medicines and medical products. FDA should consider not only disincentives for false or misleading manufacturer communications (warning letters and misbranding cases), but also positive incentives for truthful, useful, and responsible communications (thoughtful and non-paternalistic guidance).
Medical product regulation is a serious undertaking requiring rational approaches without diminishing FDA’s authority to enforce against communications and conduct that are dangerous or not in the best interest of patients or the public health and welfare. In considering policies, FDA should acknowledge the nature of truth. It is not a function of the possessor or speaker, but of the substance. In answering the question as to what situations or criteria could be used to enable manufacturers attempting to correct false or misleading third-party information, FDA should look at its own roles and impetus for its own actions for perspective.
Regards,
John Murray
At first, the questions relating to this issue seem to be pretty unremarkable, but when one considers the answers, an almost mystical reality unveils itself. Drug, biologic, and medical device manufacturers have the power to transubstantiate truth by merely uttering or possessing it. Indeed, the truth can be transformed into lies or partial truths when regulated companies communicate words that are virtually identical to words uttered by non-regulated people or organizations. The nature of FDA's question highlights a glaring contradiction in the regulatory definitions of terms like "false" and "misleading." FDA clearly understands that false and misleading information needs to be corrected, but non-commercial speech from people not regulated by FDA (the third parties) is subject to ill-defined criteria for truthfulness. Therefore, it is hard for FDA to identify the types of third-party communications that are in need of correction.
Let’s examine FDA’s request for feedback on whether or not and how companies might engage in correcting third-party misinformation about their FDA-regulated products.
In its Federal Register Notice, FDA states:
"Some manufacturers, packers, or distributors have expressed a desire to correct what are, in their belief, misconceptions or misinformation about their products, including unapproved uses of their products that are being conveyed on a Web site outside their control, … Other companies have stated that they have not corrected what they believe is misinformation in the belief that they could be viewed by such an action as being responsible for all the information on the target Web site rather than just the information that they post or submit.
The agency is interested in any data or research on how companies have approached these issues. Are there any parameters or criteria that could be used to determine the appropriateness of correcting misinformation and/or scope of information a company can provide when trying to correct misinformation on a Web site outside a company's control?
Should the parameters differentiate with regard to the prominence of the third-party site (i.e., readership), its intended audience (e.g., general public, health care professionals, patients), its intended purpose (e.g., personal diary, encyclopedia-type reference), and/or the author of the information on the site?" [emphasis added]
First of all, it is quite remarkable that FDA is asking this question in the first place. It seems to imply that there may be some skepticism as to whether or not there is a bona fide need to engage in corrective communications. Further, FDA in its background to the questions, seems to acknowledge that situations are possible, but does not acknowledge any specific situation in which it might be necessary. It implies that FDA has a vacuum of perspectives on this potential need, which to me is unfathomable.
I would answer FDA’s questions with a series of questions and somewhat pointed, and somewhat fictitious answers.
Question (to FDA): FDA, does the agency ever feel the need to communicate information on the internet in an effort to correct public misperceptions of medical information caused by third parties?
Answer (not really from FDA, but possibly-you’ll get the point): Yes, see Flu.gov and FDA’s and the CDC’s communications on H1N1 vaccine safety, efficacy, and availability. FDA and CDC are engaging in an exemplary campaign of ensuring factual information about H1N1 in the midst of dangerous misinformation and crack pot conspiracy theories. By the way, these communications concern the H1N1 vaccine. Each of these vaccines are FDA-regulated biologic products subject to FDA’s prescription drug advertising and promotional labeling requirements, but we don’t necessarily apply these requirements because we’re not manufacturers. That’s just a contemporary example. We have more examples that are similar. Did you see our social media page, by the way? Check out our Fraudulent H1N1 Products widget below.
Question (to FDA): What basic criteria does FDA use to determine when it needs to communicate corrective information?
Answer (not really from FDA, but possibly-you'll get this point too): Simple. When the existence of bad information from third parties creates a public health concern.
Question (to industry): What criteria would manufacturers use?
Answer (speaking for myself, not any manufacturers or clients): Simple again. Manufacturers could use the lowest possible threshold—The same set of requirements used by FDA and it's advertising enforcement divisions (DDMAC and APLB) for the determination of false or misleading or off-label information. For example, DDMAC frequently considers communications by drug manufacturers to be “raise significant concerns” when communications omit risk information, minimize risk information, make unsubstantiated claims, encourage unsafe or ineffective use of products, or are otherwise violative of FDA regulations. Don’t we all fundamentally agree that false or misleading information should be corrected?
Question (to industry): Do you have any examples of this?
Answer (speaking for myself, not any manufacturers or clients): Do I ever. See FDA’s website. The determination of false or misleading information and enforcement is a significant if not sacred undertaking. FDA uses a number of different criteria with which to determine that advertisements and promotional materials, including websites and other internet communication systems, could be false or misleading to the intended audiences. FDA’s enforcement actions alone are examples of the agency engaging in corrective communications where it has a statutory and public health duty and need to do so.
In many cases, FDA explicitly states that these violations raise concerns or raise public health concerns due to omission or minimization of safety information. As a baseline, the same communications could not possibly be more truthful or less misleading, merely because they are uttered by entities other than drug manufacturers. Therefore, any logical and reasonable person would conclude that there is widespread false and misleading communications on the internet, on the basis alone that unregulated communications about medical products do not comply with FDA’s content requirements imposed on drug manufacturer communications. If any news organization, ordinary citizen, or even government agency sponsors a link on a search engine or issues a 140 character “tweet” on Twitter, and these do not meet all of FDA’s disclosure and substantiation requirements, they are not regulated as false or misleading speech. If a manufacturer utters the same exact information in the same form, it can sit by its fax machine and expect a warning letter from FDA.
Question: That’s a pretty low threshold—then what criteria should FDA consider is appropriate for companies to engage in corrective communications on third party sites or publications?
Answer: It is indeed a pretty low threshold. Honestly, it is not for the agency to decide. A manufacturer should be able to use its own judgment where it sees a specific need to correct third-party communications. Moreover, these corrective actions, if done factually and without omissions, should not be considered to be promotional and subject to mechanical FDA requirements for advertising or promotional materials. Corrective communications should be narrowly tailored to the specific issue, non promotional in tone and presentation, and should contain information material to the corrective response. FDA’s fair balance requirements, labeling requirements, etc., should not be considered inherently material and should recognize the limitations of the media form (e.g., Twitter character limitations if applicable).
Don't Take this the Wrong Way
The forgoing fictitious dialogue is certainly meant to make a point. I emphatically pose to you however, that FDA has an extensive role in regulating company or company-sponsored speech. In some ways it may be taken as sarcasm and I really don’t mean it that way (for the most part). Nonetheless, as I work through this one issue in FDA’s public meeting notice, it’s hard not to see the potential for unreasonable prior restrictions or restraints on companies trying to engage in legitimate activities on the basis of fear and suspicion. By the way, I’m not making a First Amendment argument here either, just an argument about what is simply reasonable and responsible and for FDA to be a bit introspective about the nature of its own policies.
I would also propose that FDA begin to think more clearly about carving out situations and defining particular types of communications that are not advertising or labeling as defined by the Food, Drug, and Cosmetic Act and it's implementing regulations. In fact, I think its pretty clear that the FDA has broad authority to regulate commercial speech, particularly in cases where the speech is misleading or false. But the criteria for which FDA considers information to be misleading based on an overly broad application of advertising and labeling regulations needs to change. FDA suffers from an inability to define manufacturer communications as anything but labeling or advertising. This constrains both FDA and manufacturers in ways that don’t serve the public health.
I’m also not saying that FDA should apply its regulations to all forms of speech or communications. That’s simply ludicrous. I’m only saying that FDA should not impose criteria on manufacturers for correcting third party communications, where there is a legitimate need to do so. FDA should harness the self-interest of manufacturers to help ensure the safe and effective use of medicines and medical products. FDA should consider not only disincentives for false or misleading manufacturer communications (warning letters and misbranding cases), but also positive incentives for truthful, useful, and responsible communications (thoughtful and non-paternalistic guidance).
Medical product regulation is a serious undertaking requiring rational approaches without diminishing FDA’s authority to enforce against communications and conduct that are dangerous or not in the best interest of patients or the public health and welfare. In considering policies, FDA should acknowledge the nature of truth. It is not a function of the possessor or speaker, but of the substance. In answering the question as to what situations or criteria could be used to enable manufacturers attempting to correct false or misleading third-party information, FDA should look at its own roles and impetus for its own actions for perspective.
Regards,
John Murray
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