I have been reading the new guidance from the FDA on distributing reprints while preparing a Regulatory Alert, which should be released on Monday or Tuesday. One thing that really stood out to me is the change in the background section.
The background section from the 2009 final guidance had a three-paragraph section lasting less than one page. By contrast the new guidance has a background section that spans five pages and 15 paragraphs, with almost as much contained in footnotes detailing the legislative history as in the guidance itself.
This document definitely reads to my eyes far more as if it were written with the intention of being defended in a court of law than the 2009 version.
I'd love to hear from anyone who had a similar impression.
Agree, Dale. This was one of my first impressions, too. It reminds me of the "Attachment" at the end of the FDA's 2009 risk guidance, in which FDA puts forth the fairly technical legal/regulatory argument why the "fair balance" requirement (only explicitly called out for prescription drug “advertising”, 21 CFR 202.1) essentially applies to all other types of promotion (so-called "promotional labeling”). In general, I do find the background helpful, especially in areas where the law/regulations are inexact.
ReplyDeleteI’m also glad FDA removed “Good Reprint Practices” from the title of the revised guidance (it's now "Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices”). I always found "GRPs" a bit of a misnomer, as it suggests that the guidance is a broad set of guidelines on the use of reprints by manufacturers, when in fact the guidance does not provide any information whatsoever on promotional use of reprints, a far more common use by manufacturers than the narrow “safe harbor" of non-promotional dissemination of off-label reprints. Although I understand FDA’s reluctance, I do think some guidelines for promotional use of on-label reprints (as was done in the defunct 1996 reprint guidance) could be helpful to manufacturers who now operate in this area primarily according to the common practices of their peers.
John Driscoll
Twitter: @OPDPresources
Websites: www.SubstantialEvidence.com
www.OPDPresources.com
That's a great point, John. I really enjoy that guidance. It largely collected a lot of FDA's complaints from hundreds of letters and put them into the larger context. And the appendix is grossly underappreciated.BTW, here's the link to the guidance: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf
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