Good Reprint Practices

It’s not lost on me that I’ve been taking a long time to get through my analysis of the Good Reprint Practices guidance.  My first problem is that I’m busy with other things, which in most cases, is a really good thing.  My second problem is that I sometimes go on fantastic voyages into the simplest of details.  However, I can’t stress enough that even the subtlest of details of this guidance should not be oversimplified.  On the other hand my goal is to be helpful, and not to drown my readers in complexities, that no matter how thoughtful and accurate, are incomprehensible and useless.

All that said, as I examine the basic requirements of reprints disseminated under this guidance, I feel inspired to highlight some very important language that needs to be considered carefully.  Some of the more basic elements of the guidance are straight forward. 

The Basics

When FDA explains the types of articles that can be distributed under this guidance, it starts with an explanation of the types of publications from which the individual articles can be taken, essentially peer-reviewed medical journals and “textbook” reference publications (published independent of manufacturers and commercially available for sale).  For this post I’m focusing on journal reprints.  In FDA’s final “Good Reprint Practices” guidance document, the basic nature of journal reprints can be summarized as follows.  They must come from medical journals that have the following characteristics:

1.     An editorial board that is expert in the specific subject matter of the article, and be able to independently review, objectively select, reject or comment on the articles that are published in the journal.

2.     The journal must have publicly stated policies (and must adhere to), full disclosure of any conflicts of interest or biases of study authors, contributors, or editors with the journal or organization.

3.     Be peer reviewed in accordance with the procedures of the organization; and

4.     Not be a manufacturer-funded supplement

Historically, these are well understood to mean that the journals from which articles come are peer-reviewed publications with typical scientifically rigorous editorial standards.  Think, New England Journal of Medicine, Journal of the American Medical Association (JAMA), The Lancet, Circulation, etc.   In the now obsolete Final Part 99 Rule that implemented FDAMA 401, these articles were validated in one way by reference in the Index Medicus, representing journals indexed by the National Library of Medicine for inclusion in MEDLINE.  Among the criteria applied by NLM for the Index Medicus are editorial standards similar to those required in Good Reprint Practices.  Editorial standards applied to selection in the Index Medicus are as follows:

Quality of editorial work: The journal should demonstrate features that contribute to the objectivity, credibility, and quality of its contents. These features may include information about the methods of selecting articles, especially on the explicit process of external peer review; statements indicating adherence to ethical guidelines; evidence that authors have disclosed financial conflicts of interest; timely correction of errata; explicit responsible retractions as appropriate; and opportunity for comments and dissenting opinion. Neither the advertising content nor commercial sponsorship should raise questions about the objectivity of the published material. Sponsorship by national or international professional societies may be considered.

FDA’s now obsolete Part 99 Regulation required that the journals from which articles were disseminated be listed in the Index Medicus.  FDA’s 2009 guidance document does not have this explicit requirement, however, it is a virtual requirement for all intents and purposes.   Nonetheless, its absence may be a sign that this listing, while important, is not a fool-proof validation of the appropriateness of the publications’ policies or practices.

But John, this is all bread and butter stuff, why waste so many brain cells on this?

Now of course you may be wondering why I’m spending an inordinate amount of time on this subject.  Wonder away, but here’s why.  There are very subtle word choices that companies need to pay attention to.  I will highlight a couple.  Good Reprint Practices requires that journal articles: 

“be published by an organization…that has a publicly stated policy, to which the organization adheres, of full disclosure of any conflict of interest or biases for all authors, contributors, or editors associated with the journal or organization” [emphasis added]

“be peer-reviewed and published in accordance with the peer-review procedures of the organization” [emphasis added]

Explicit and implicit in FDA’s word choice is that it is not enough to have standards, policies or procedures, or even to call yourself “peer reviewed.”  It is not enough to be listed in the Index Medicus.  When choosing an article to disseminate under the Good Reprint Practices guidance, you must choose an article from a journal that actually adheres to its standards.  Having knowledge that journals have standards consistent with FDA’s guidance is one piece of validation, but in some cases the validation must be validated.  Or, at the very least, if you have knowledge that might question the validity of the publication’s policy adherence, you ought to put that knowledge to good use, particularly if non-adherence to your own company’s policies could have contributed to the medical publisher’s non-adherence.

“What’s Reasonable?”  Wrong Question.  ”What’s Unreasonable?”

A painful reality in recent years, is that journal publishers, editors, authors, investigators, publication companies, and manufacturers have come under heavy criticism for certain practices when it comes to medical publishing.  Ghost writing, financial conflicts, data suppression, and outright fraud, have been part of the dialogue of medical publishing in recent years.  Even the most respected journals have been implicated.  Whether or not these issues represent systemic problems, or are in fact illegal in each instance is open to arguments.  Further, I have no doubt that measures have been taken to improve the situation, on the part of both publishers and manufacturers.  Nonetheless, all of these publications had editorial policies to ensure proper disclosures, editorial standards, peer-review processes and so on even during the periods of alleged violations.  Problem was, apparently, that they were either ineffective or were not being adhered to in some circumstances. 

It might seem unreasonable as well, if you are a manufacturer, to be expected to validate the adherence of a journal to its own policies or standards.  Therefore, maybe we just have to rely on the statements of the policies, practices, and standards of the publishers.  The problem is that manufacturers, either directly, or through its agents (e.g., publication companies), the authors (who may be paid consultants or investigators of the manufacturer), and even the publishers’ employees or agents themselves (who sometimes have a less-than-adequate understanding of their own policies), may all cooperate with with one another at the time of authorship or publication in a way that might make the manufacturer complicit in cases of non-adherence. 

A further problem is that while publishers today may have stated and effective policies and standards, these may not be the same policies and standards that were in effect at the time the article that you are seeking to disseminate was published.  For instance, financial disclosure policies or “ghost-writing” policies for a publication in 2009 might be very different or more explicit than they were in 2001.  If you are disseminating an article of the company’s research from a 2001 publication, do you need to worry about the integrity of the article’s authorship and editorial review? 

Are your own company’s standards today different or more explicit than they were in 2001? 

What about the evolution of your own company’s compliance program? 

Do you have any idea of employee involvement in publications planning or authorship eight years ago?

Do you know whether or not you had business plans or publication plans or publication strategies for which you were paying publication companies at the time the article was authored and published?  If so, what were those plans and strategies?  Would you still support those strategies today?  Would they be viewed as non-adherent to the medical publishers’ current policies?

I wouldn’t say these issues will apply in all circumstances, but if you are planning to disseminate articles under Good Reprint Practices, you may want to exercise particular diligence for these issues.  A good compliance program should be able to help investigate these issues and to maintain appropriate practices after dissemination.  I’ll admit it sometimes seems crazy to have to go to such elaborate means to comply with the Good Reprint Practices guidance, but today we see a lot of looking back on decisions that were made years ago in fraud and misbranding cases and the issues look pretty obvious in hindsight.  However, at the time people were caught up in routine and (often oxymoronic) conventional wisdom.  Off-label reprint dissemination is not, and probably should not be, routine.

In many ways, the publications world and the world of reprint dissemination have experienced a nuclear incident.  Companies need to understand the confines of the fallout zone, and measure when and if the radiation has diminished to safe levels.

Yours Truly,

John

Postscript: Leave A Comment // Subscribe (RSS Feed)

The Next Post: Sidetrack: FDA Takes on Internet Promotion
The Previous Post: What is a New Intended Use? FDA Regulation, Apocalypse Now and Dialectic Physics