In a move that has many wondering where it came from (as it was not on the Bush list of priorities prior to leaving office), the FDA has issued Guidance for Good Reprint Practices for the Distribution of Medical Journal Articles and Reference Publications. The Guidance allows for manufacturers’ representatives to distribute peer-reviewed information to medical professionals.
The Guidance is not met without opposition as Congressman Henry Waxman has been a constant critic of allowing dissemination of journal articles.
According to the FDA, this is not a “new” rule and up until September 30, 2006 when the Federal Food and Drug Administration Modernization Act (FDAMA) sunset, the distribution of peer-reviewed articles was permitted protected speech and considered a safe harbor.
Types of reprints allowed include:
• Are published by an organization with an independent, expert editorial board and a publicly stated policy on conflicts of interest.
• Are peer-reviewed.
• Are not false or misleading. Examples of false or misleading articles are those that have been withdrawn by the journal or disclaimed by the author, or that report on studies that are inconsistent with the weight of credible evidence.
• Do not pose a significant health risk, if relied upon.
• Are not special supplements funded by the manufacturer, letters to the editor, abstracts, or reports of phase 1 studies in healthy subjects.
It would not be surprising if The Journal of the American Medical Association (JAMA) were to issue an editorial on the dangers of journal reprint distribution, which given the revenue stream that JAMA gets from reprints, this would be duplicity at its best.
Several law firms have produced analysis of this guidance, including Hogan and Hartson, Sidley Austin and Hyman Phelps.
One limiting factor for this action may be that several companies have agreed not to distribute off-label information in their recent corporate integrity agreements.
Some critics are hopeful that the Obama Administration will pull this guidance upon taking office, but because there has been no proof of harm by the distribution of peer-reviewed articles by reps, this may not be the best course of action.
Reference Materials
FDA 1-13-08: GUIDANCE FOR INDUSTRY
The Associated Press: FDA OKs sharing unapproved drug uses with docs
Medical Marketing and Media: FDA OKs distribution of journal articles on off-label uses
Reuters: US lets drugmakers advise doctors on unapproved uses
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