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FEATURES << Good Reprint Practices: recent guidance from the FDA
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Good Reprint Practices: recent guidance from the FDA
Published 4 March 2009, written by Paul Chrisp
In January 2009, the FDA finalized its guidance for industry on the distribution of reprints from medical journals that discuss unapproved or ‘off-label’ indications. This follows a year of consultation on the draft guidance that saw the industry push for greater freedom in the dissemination of information on off-label uses on the one hand, and consumer groups and politicians arguing against what they saw as an erosion of consumer protection and unnecessary exposure to potentially unsafe and untested drugs bypassing FDA review on the other. In the end, the new guidance attempts to balance both views, and recognizes that articles on unapproved uses can contribute to advances in clinical practice and patient care.
The guidance allows manufacturers to give out reprints on off-label indications, but with clear principles, the Good Reprint Practices, that are intended to prevent overt promotion. The practices include the following:
Articles should be published by an organization that has an independent editorial board and has a full and accessible conflict of interest and disclosure policy for authors, contributors and editors
Articles should be peer-reviewed, and not published in a specially funded supplement
Information should address well controlled clinical investigations, such as controlled studies, pharmacokinetic and pharmacodynamic studies, and meta analyses
Information should not be abridged, highlighted, marked or summarized in any way
Reprints should be accompanied by approved labeling and, where it exists, by a comprehensive bibliography and a representative publication that reaches a different conclusion regarding the unapproved use
Reprints should be distributed separately from promotional information, and should carry prominent statements disclosing any conflict of interest and that the information discusses unapproved uses
The guidelines also mention that medical reference publications must not be primarily distributed by, prepared at the request of, or significantly influenced by industry. Assuming this refers to publications such as textbooks, it has less relevance to publication planning than the guidance for journal articles, as few publication plans include books or similar material.
Will this be enough to placate the critics? Possibly not. There remains a feeling that the FDA will be unable to enforce the guidance, as reprints will be handed out by reps behind closed doors in doctors’ offices. Furthermore, compliance will be voluntary because the industry will not be obliged to submit articles to the FDA prior to distribution. This is in contrast to the rule in the Food and Drug Administration Modernization Act (FDAMA) which expired in September 2006 and which the new guidance replaces. In the FDAMA, off-label reprints were permitted but only if the manufacturer submitted the article in advance to the FDA and agreed to conduct trials in the unapproved indication and file a supplemental new drug application to the FDA for approval within three years. Critics are concerned that without this provision the industry will promote and achieve off-label use through distribution of reprints rather than by conducting properly controlled clinical trials.
Are these concerns valid? The over-riding concern is that uncontrolled off-label use will increase and potentially harm patients, or at least deny them proven effective treatments, and possibly increase costs. But many off-label uses eventually become the standard of care. Moreover, already most off-label use takes place without strong supporting evidence but in indications that are not of high clinical impact – in other words, it may not be a big deal. So generalized strategies to limit off-label use may not have a significant benefit on patient care and may actually limit the use of newer clinically beneficial evidence-based treatments.
So what is the likely impact of the Good Reprint Practices on the publication planning community? It is now possible for smaller studies (e.g. investigator-initiated trials, PK/PD studies, open label studies) in off-label indications to be published and distributed as reprints. The industry can instigate these trials, conduct subanalyses, publish results and make them a key part of their clinical development and strategic marketing platform. There is likely to be an increase in calls for papers from publishers, particularly smaller organizations publishing second-tier journals that comply with the requirements of the Practices. And of course there is an opportunity for medical communications agencies to work with their clients to identify target indications, and integrate them into their communication plans. Yet to be truly effective and benefit those in the industry, as well as patients and clinical care, the Good Reprint Practices need to be credible. They cannot be seen in isolation, and must instead be integrated with Good Publication Practice, ICMJE guidelines, and FDAAA requirements for registering trials.
About the author
Paul Chrisp has many years of experience in publishing, continuing medical education and medical communications.
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Feedback: Do you have any comments about this article? Contact the Publisher, Peter Llewellyn.
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