Free and Fair and FDA

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  • 03/04/2014

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A new draft guidance document released by the U.S. Food and Drug Administration (FDA) aims to clarify the ways in which a pharmaceutical or medical device manufacturer may use scientific and medical literature to promote its products, even if the literature doesn't conform to the product's FDA-approved uses. FDA's guidance forms a checklist of sorts that companies will need to check against each instance of literature they wish to promote.

FDA's new draft guidance document, Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices, is meant to provide life science companies with a checklist for making sure they stay within the acceptable limits of promotion of scientific and medical publications. The guidance is a revision of a 2009 draft guidance, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices. As noted by Regulatory Focus, that guidance came under fire from life science companies, which argued that it restricted their ability to "promote the public health" by distributing scientific information informing the safe and effective use of their products.

In an accompanying statement, the FDA stated that it's currently working on additional guidance on scientific exchange, responding to unsolicited requests for off label information, and interactions with formulary committees. 

This draft guidance shows that the agency is getting the message that it must conform its policies and practices to the First Amendment," said Coalition for Healthcare Communication Executive Director John Kamp in a released statement. "Manufacturers should be able to distribute truthful information – in the form of journal articles, medical textbooks and practice guidelines."

In an Industry Leaders Alert, Kamp also stated: "These actions, combined with recent guidance on social media and a new study on the effectiveness of current warnings on TV commercials, suggest that the FDA is serious on updating critical marketing policies, perhaps in recognition of the First Amendment challenges it faces is defending current policy."

"While these are small steps forward, they are significant nonetheless and will enable more reasonable communication between regulated companies and medical professionals, leading to more efficient and effective patient care. The new draft guidance also supports our case with CMS that journal reprints and reference textbooks should be exempt from reporting under the Sunshine Act."


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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