Aug. 10, 2015 – Late last week the U.S. District Court for the Southern District of New York granted Amarin Pharma Inc.’s request for an injunction to stop the FDA from enforcing rules that prohibit companies from communicating to physicians truthful and non-misleading information about the off-label uses of their products. Below, Coalition for Healthcare Communication Executive Director John Kamp offers insights on the Amarin v. FDA ruling.
U.S. District Judge Paul A. Engelmayer scored a precise but direct hit on FDA’s traditional ban of truthful and non-misleading off-label marketing of drugs, citing recent First Amendment cases, including U.S. v. Caronia and the U.S. Supreme Court decision in IMS v. Sorrell.
Today’s decision for Amarin Pharma in Amarin v. FDA brings to a head more than 20 years of wrangling between the industry and the FDA on the applicability of the First Amendment to FDA off-label marketing. Furthermore, it leaves little room for FDA to protect its existing enforcement scheme, and puts all that much more pressure on the agency to provide new policy guidance in this area.
For example, the Amarin decision casts doubt on FDA’s long standing rules enabling limited “scientific exchange” with some professionals, but banning the promotional communication by the sales force and media marketing. It also undermines the traditional FDA distinction between solicited and unsolicited information dissemination by companies. The decision affirmed that marketing is clearly protected under the First Amendment.
Henceforward, the standard for allowable marketing will not end with the FDA approved label, but will enable marketing beyond the label that is both true and not misleading. The exact contours of that may take years to become clear.
The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Medical Information Working Group (MIWG) have submitted various petitions to the FDA over the past few years seeking revised guidance on several related issues, including clearer definitions of “scientific exchange,” peer-reviewed journal distribution, communication with payers and formulary committees, etc. These petitions offer clues to the next stage of allowable communications.
FDA has been promising revised off-label guidance for several months, but missed its own deadline of Jan. 1, 2015, and has not yet held its announced but unscheduled public hearings this summer. At the same time, legislation encouraging fast resolution of these issues has passed the House as part of the 21st Century Cures legislation and is now awaiting action in the Senate.
It is difficult to predict just when and what will happen next, and industry is warned not to change its off-label policies based only on this decision. However, it is clear that the era of bans on truthful off-label marketing is coming to an end.