Relaxing Rules for Off-Label Prescribing: "Akin to Crying 'Fire!' in a Crowded Theater?"

In the Amarin court case, the court ruled that the company has the right, under the First Amendment, to promote information to health-care professionals about certain uses of the drug Vascepa that aren't covered by the drug's FDA-approved labeling -- as long as the information is true and not misleading (read "Amarin Wins Off-Label Case Against FDA"). This case is likely to influence new guidance from the FDA regarding off-label drug promotion by pharma marketers.

"Might changes in rules for promotion of off-label indications based on free speech arguments lead to a situation akin to crying fire in a crowded theater?," asks authors of Commentary published in the recent issue of JAMA Internal Medicine. The authors of the commentary -- Chester B. Good, M.D., M.P.H., and Walid F. Gellad, M.D., M.P.H., of the Veterans Affairs Pittsburgh Heathcare System -- referred to "compelling evidence" that "off-label prescribing is frequently inappropriate and that prescribing in these circumstances increases the risk for an adverse event substantially."

That evidence was presented in a study published in the same issue of the journal titled "Off-label Prescription Drug Use and Adverse Drug Events" (JAMA Intern Med. Published online November 2, 2015. doi:10.1001/jamainternmed.2015.6058).

What is the "compelling evidence?"

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