Good Reprint Practices

While there are fears, accusations, and criticism that the final Good Reprint Practices guidance document will allow drug and device companies to now “promote off-label uses,” this is not at all the case.  Such views represent a fundamental misunderstanding of the plain language of the final guidance document, a fundamental misunderstanding of the extent of FDA’s authority, and a fundamental misunderstanding of how a company can, in a practical sense, comply with this guidance document AND avoid federal prosecution for misbranding (due to promotion of unapproved uses).

Think about this.

FDA was criticized for not seeing to the renewal of FDAMA 401 and its implementing regulations (21 CFR Sec. 99.1). This law (and consequently, this regulation) sunsetted in September 2006 and FDA can no longer enforce these requirements.  The fear here, is that without this law, FDA cannot police off-label promotion.  However, it is important to understand, that following the outcome of the Washington Legal Foundation case in the late 90’s, FDA could not require companies to use FDAMA 401 if the companies wished to disseminate journal articles discussing off-label uses.  FDA could only consider FDAMA 401 to be a safe harbor, but it could not hold companies in violation of the law if they did not comply with this statute.  Companies could, theoretically, disseminate off-label reprints if they followed what came to be known as the WLF model.  

Among the critical differences between FDAMA 401 and WLF were that FDAMA 401 required that (among other things): 1) companies certify that they would pursue studies necessary to gain approval for the associated use; 2) companies had to submit the required articles to FDA for review 60 days prior to the intended dissemination date (FDA could then make a decision whether or not the articles were appropriate and if FDA would require additional qualifying information); and 3) companies had to track the dissemination and submit periodic reports to FDA.  Dissemination under the “WLF” model required none of these things.  The courts in the WLF case affirmed that (essentially) FDA could require:  1) that the articles were not false or misleading (which is a matter of extraordinary judgement); 2) that the articles contain conspicuous notification that the uses discussed were not FDA approved; 3) that the articles were from a peer-reviewed publication; and 4) that financial interests of the company in the products or research discussed was dislcosed.  

If a company was pursuing approval for the relevant off label use, complying with FDAMA 401 took some work, but (I can say from personal experience) was relatively feasible.  However, most available information on off-label uses of products concerns uses for which companies have no plans (or in some cases, no practical regulatory pathway) to get these uses approved.  That requirement alone restricted FDAMA 401 dissemination for the substantial majority of available peer reviewed articles.  The “WLF model” did not have this requirement.  

Ahhh…the good old days.

For critics of the Good Reprint Practices guidance document, it seems romantic to look back on the days before the sunsetting of FDAMA 401 as a time when FDA had the teeth to keep companies from promoting their drugs or devices for off label uses.  Good Reprint Practices represents the changing season, full of dangerous and naive bliss.

For companies, perhaps, it may seem romantic to look back to a time when the WLF kept FDA off companies’ backs.  It may also seem like the Good Reprint Practices guidance is full of the promise of springtime, a time when anything seems possible.  

Well, point of fact, a lot is possible.  A lot of these possibilities are not new today and were present from 1997 to 2006.  FDA has enormous enforcement discretion and authority (along, importantly, with the DOJ) to prosecute companies for misbranding their products by promoting them for off label uses.  FDA reminds the public in its Good Reprint Practices guidance that its authority in this area “has not changed.”  Take a look at the unprecedented and record breaking cases involving misbranding that have happened in the past few years.  The conduct that led to these settlements occurred during a period where FDA had FDAMA 401 in effect (but were restricted to interpreting it as anything but a safe harbor).  The evidence in each case relates to far more than the dissemination of articles.  

FDA retains the authority (and the tools) under FDAMA 401 or Good Reprint Practices to find evidence of intended uses in every corner of the company.  Nobody was prosecuted for simple reprint dissemination during the period in which FDAMA 401 was in effect.  Companies that have internal strategies to grow their products or increase sales for off-label uses will inevitably have a treasure chest of internal evidence for a misbranding case.  Reprint dissemination under the Good Reprint Practices guidance is only one piece of potential evidence.  Further, it is foreseeable that the government will argue that in the face of clear evidence of the intent to increase sales for products for off-label uses, companies could disqualify any claims to a potential Good Reprint Practices “safe harbor.”  Also, as a practical matter, companies without comprehensive (and truly effective) regulatory compliance programs will fail to comply with Section B of Good Reprint Practices “Manner in which to Disseminate Scientific and Medical Information.”  Companies that have bad intentions will have bad evidence, even if they have good intentions. Huh?

Ahh…the good old days and the promise of Spring.

Yours truly,

John

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