The FDA opened the forum for comments about off-label drug promotion with the February release of its draft guidance, kicking off a comment period that wraps in April.
The recommendations update guidelines from 2009—the regulator notes in the February draft that the procedures described are not binding and “do not establish legally enforceable rights or responsibilities”—which have steered industry communications about unapproved uses of FDA approved medications.
The 2014 refresh includes distinct recommendations for scientific and medical journal articles, scientific or medical reference texts and clinical practice guidelines.
The recommendations include items such as distributing medical journal or scientific articles that have been peer-reviewed and are unabridged, while excluding items such as letters to the editor, abstracts or healthy volunteer studies from the list of publications which could be considered a suitable medical journal or scientific article.
FDA recommendations for scientific and medical reference texts indicate a preference for peer-reviewed material and that it be “distributed separately from the delivery of information that is promotional in nature.” These guidelines also recommend prominently disclosing an author’s financial interest, and if a portion of a medical text is being distributed, that the unaltered text contain “a prominently displayed and permanently affixed statement identifying the distributing manufacturer.”
Clinical Practice Guidelines (CPG) get a similar treatment, with one exception: a subsection about recommendations for the distribution of what it calls trustworthy CPG materials. Recommendations for veracity include ensuring only the most recent CPGs are distributed and that CPG materials be distributed at a different time than promotional information.
The CPG guidelines also include a sales call scenario in which a sales person does not distribute CPG materials if that visit includes promotional leave-behinds. This scenario also recommends keeping sales reps out of the loop and recommends that medical communications officers—not sales representatives—answer CPG-related questions.
The significance of these changes is a matter of perspective. Senior food-and-drug-law attorney Arnie Friede told MM&M that the new guidelines could be particularly onerous for companies who are already bound by corporate integrity agreements.
Friede said that if the corporate integrity agreements are more stringent than the FDA draft guidelines, there may not be a concern, but a problem could arise if the restrictions are out of synch. The Sandler, Travis & Rosenberg attorney, who previously worked as senior counsel for Pfizer, added that the new guidelines “may be a day late and a dollar short in the sense that people are already being deterred from disseminating off-label information.”
The interest group Coalition for Healthcare Communications (CHC) said in a statement that the new recommendations include improvements, such as distinct guidelines for clinical practice guidelines and drawing a division between scientific/medical journals and scientific/medical texts.
The group, quoting from the guidelines’ intro, notes that this update shows the regulator acknowledges that off-label uses can have value when supported by truthful material.
John Kamp, CHC’s executive director, told MM&M in an email that there’s “no way to quantify the economic impact” that the previous guidelines or the new ones could have on money spent on printing and distributing this material, and that the difference could be considerable.
Sarah Ray of the research firm Cutting Edge Information also emailed MM&M that it is too early to calculate the impact these guidelines could have on how the healthcare industry may spend its communications budget. Ray noted, however, that the industry has embraced technology, with tools such as PharmaWall, the tool created by agency Intouch Solutions which monitors content posted to company sites to help them avoid off-label infractions.