May 22, 2014 – Both sides of the argument over whether sales representatives’ speech about off-label drug uses are protected by the First Amendment are addressed in a May 21 posting in The New Yorker. The author summarizes the recent U.S. Supreme Court decisions in IMS V. Sorrell and in U.S. v. Caronia that could give those that support the free speech argument “more traction” and discusses reaction to the FDA’s recent call for comment on draft guidance regarding off-label use promotion.
“As doctors continue to prescribe drugs for off-label uses, they need information about how those uses stand to effect patients,” author Kiel Brennan-Marquez writes. However, “the parties with the most information – pharmaceutical sales reps – inherently have financial incentives to promote off-label uses.”
“The question is not whether the FDA rules on off-label communication will change, but rather how soon and how extensive those changes will be,” said Coalition for Healthcare Communication Executive Director John Kamp. “The New Yorker report does a fine job explaining the law in lay terms, as well as foreshadowing the dimensions of the debate. It’s a must-read for professionals in medical marketing.”
To view the full posting, go to: http://www.newyorker.com/online/blogs/currency/2014/05/a-new-kind-of-free-speech-drug-reps-pitches-to-doctors.html