Posted: 07 Dec 2016 02:33 AM PST
By Jeffrey N. Wasserstein –
Most of our readers come to the blog to read posts that are well-researched, provide thoughtful analysis, and often practical advice. This is not that post. This is a post that will be filled with rank speculation, perhaps a little wishful thinking, and a soupçon of advice. The latter may be food for thought; the former almost certainly will not be.
Many writers and analysts who are far more thoughtful and in the loop than this blogger have spilled ink on what will happen to FDA. Will the Trump Administration retain the commissioner and Chief Counsel or will they be replaced? Will there be dramatic changes or only changes at the margin? Those issues are beyond my ken and beyond the scope of this blogpost. Rather, we will spend a few minutes and a few ones and zeroes across the interwebz to focus in on promotional activities, that is, free speech.
Your faithful blogger can claim no special knowledge or access other than hallway conversations with colleagues and a Twitter feed that is replete with all sides of the spectrum (other than Pepe the frog. My Twitter feed is a frog-free zone.) And thus, we descend into speculation.
Here’s what we know – when Republican administrations take over from Democrat administrations, there tends to be some relaxation of enforcement taken against industry for promotional activities. In an N=1 situation, for example, when the Bush administration took over from the Clinton administration, the warning letter process was centralized in the hands of the Chief Counsel of FDA, who was, at the time, one of the foremost proponents of the First Amendment protections for industry sponsored speech. This resulted in a dramatic decrease in the number of warning letters related to promotional activities. We apologize for our N=1 exercise, but your loyal blogger was still in knee pants when President Reagan took over from President Carter – the next most recent such event. Moreover, this is a relatively risk-free area for deregulators to play in – it doesn’t carry the same dangers as say product safety.
But what does that mean in the context of a Donald Trump presidency? As avid followers of such issues know, the First Amendment is already ascending. Indeed, our friends at FDA have issued only five promotional enforcement letters for pharmaceutical products in 2016 to date, which is a sharp dropoff from years past, and many of them are not the typical letters of days of yore, but are much more circumscribed to speech that is arguably not protected by the First Amendment.
But will the typical progression from a Democratic administration to a GOP one hold true in this instance where Candidate and now President-Elect Trump has made numerous comments on the campaign trail suggesting his view that the First Amendment might not be as fixed in the firmament as it has been in the past. Granted, his targets have been the press and flagburning, neither of which are politically popular, but nevertheless, it gives one pause to think about how aggressive an FDA under President Trump might expand the First Amendment protections given to industry.
Another related area is social media. @realDonaldTrump is an inveterate Twitterer and an avid Facebook user as well. As this blogger has frequently complained, FDA has only barely dipped their toes into the issue of social media. One area of interest that remains in flux is the ability to use Twitter and other space limited platforms where it may be necessary to communicate safety information. Would a tweet @realDonaldTrump help convince the President-Elect that the time has come for allowing companies with therapeutic products to use Twitter to engage with other users? (We will, of course be tweeting this blogpost to try to catch his attention.) Will tweeting @mike_pence help? Anyone from Eli Lilly (@LillyPad) or other Indiana-based companies want to pass this along to their governor/Vice President-Elect? (Yes, we are attention seekers.)
Ok, enough with the speculation. Here’s the practical bit of advice (not legal advice, this is just a blogpost). Stay the course for now. The First Amendment is already front and center at the Agency. They just held a public meeting about off label information in which the presenters appeared to be evenly divided between those who favored more speech and those who didn’t (see our previous post here). FDA will have a difficult time threading that needle without offending the courts who seem inclined to permit truthful and not misleading speech. If you have data that can be presented in a truthful and not misleading manner, it seems that that will not readily draw a letter from FDA. Note, however, that if there is even a whiff of fraud or a kickback or some other hook, that the protected speech aspect may not be enough to protect the entirety of the challenged conduct.
In short, we are not predicting that the floodgates can open and all speech will be unchallenged. This is in part because FDA has already reined itself in to some extent in light of the court challenges. Thus the transition from the Clinton to Bush administrations may not be an apposite example. So proceed as before, but continue to proceed with caution. (In terms of predictions, I also predicted that the New York Jets would take their division, so definitely proceed with caution.)
How about social media? I suppose it depends on how much risk a company is willing to take. FDA has stated:
We appreciate you sticking through to the end of our meanderings and will now return you to our regularly scheduled program of thoughtful analysis and informative blogposts.
Most of our readers come to the blog to read posts that are well-researched, provide thoughtful analysis, and often practical advice. This is not that post. This is a post that will be filled with rank speculation, perhaps a little wishful thinking, and a soupçon of advice. The latter may be food for thought; the former almost certainly will not be.
Many writers and analysts who are far more thoughtful and in the loop than this blogger have spilled ink on what will happen to FDA. Will the Trump Administration retain the commissioner and Chief Counsel or will they be replaced? Will there be dramatic changes or only changes at the margin? Those issues are beyond my ken and beyond the scope of this blogpost. Rather, we will spend a few minutes and a few ones and zeroes across the interwebz to focus in on promotional activities, that is, free speech.
Your faithful blogger can claim no special knowledge or access other than hallway conversations with colleagues and a Twitter feed that is replete with all sides of the spectrum (other than Pepe the frog. My Twitter feed is a frog-free zone.) And thus, we descend into speculation.
Here’s what we know – when Republican administrations take over from Democrat administrations, there tends to be some relaxation of enforcement taken against industry for promotional activities. In an N=1 situation, for example, when the Bush administration took over from the Clinton administration, the warning letter process was centralized in the hands of the Chief Counsel of FDA, who was, at the time, one of the foremost proponents of the First Amendment protections for industry sponsored speech. This resulted in a dramatic decrease in the number of warning letters related to promotional activities. We apologize for our N=1 exercise, but your loyal blogger was still in knee pants when President Reagan took over from President Carter – the next most recent such event. Moreover, this is a relatively risk-free area for deregulators to play in – it doesn’t carry the same dangers as say product safety.
But what does that mean in the context of a Donald Trump presidency? As avid followers of such issues know, the First Amendment is already ascending. Indeed, our friends at FDA have issued only five promotional enforcement letters for pharmaceutical products in 2016 to date, which is a sharp dropoff from years past, and many of them are not the typical letters of days of yore, but are much more circumscribed to speech that is arguably not protected by the First Amendment.
But will the typical progression from a Democratic administration to a GOP one hold true in this instance where Candidate and now President-Elect Trump has made numerous comments on the campaign trail suggesting his view that the First Amendment might not be as fixed in the firmament as it has been in the past. Granted, his targets have been the press and flagburning, neither of which are politically popular, but nevertheless, it gives one pause to think about how aggressive an FDA under President Trump might expand the First Amendment protections given to industry.
Another related area is social media. @realDonaldTrump is an inveterate Twitterer and an avid Facebook user as well. As this blogger has frequently complained, FDA has only barely dipped their toes into the issue of social media. One area of interest that remains in flux is the ability to use Twitter and other space limited platforms where it may be necessary to communicate safety information. Would a tweet @realDonaldTrump help convince the President-Elect that the time has come for allowing companies with therapeutic products to use Twitter to engage with other users? (We will, of course be tweeting this blogpost to try to catch his attention.) Will tweeting @mike_pence help? Anyone from Eli Lilly (@LillyPad) or other Indiana-based companies want to pass this along to their governor/Vice President-Elect? (Yes, we are attention seekers.)
Ok, enough with the speculation. Here’s the practical bit of advice (not legal advice, this is just a blogpost). Stay the course for now. The First Amendment is already front and center at the Agency. They just held a public meeting about off label information in which the presenters appeared to be evenly divided between those who favored more speech and those who didn’t (see our previous post here). FDA will have a difficult time threading that needle without offending the courts who seem inclined to permit truthful and not misleading speech. If you have data that can be presented in a truthful and not misleading manner, it seems that that will not readily draw a letter from FDA. Note, however, that if there is even a whiff of fraud or a kickback or some other hook, that the protected speech aspect may not be enough to protect the entirety of the challenged conduct.
In short, we are not predicting that the floodgates can open and all speech will be unchallenged. This is in part because FDA has already reined itself in to some extent in light of the court challenges. Thus the transition from the Clinton to Bush administrations may not be an apposite example. So proceed as before, but continue to proceed with caution. (In terms of predictions, I also predicted that the New York Jets would take their division, so definitely proceed with caution.)
How about social media? I suppose it depends on how much risk a company is willing to take. FDA has stated:
Regardless of character space constraints that may be present on certain Internet/social media platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication. The firm should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product.It would be hard to back off of that without a lot of internal effort. But it will be interesting to see if companies are willing to test this, perhaps by tweeting and including a tinyurl to risk information rather than including it directly.
We appreciate you sticking through to the end of our meanderings and will now return you to our regularly scheduled program of thoughtful analysis and informative blogposts.
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