Jan. 3, 2014 – From Coalition for Healthcare Communication Executive Director John Kamp:
Several weeks ago I was privileged to participate in this year’s CMS/FDA Summit, produced by the editors of The RPM Report. Among the most interesting panel presentations was that titled “Beyond the Label,” featuring Mit Spears, General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA), and Coleen Klassmeier, partner at Sidley Austin and counsel to the Information Working Group of 13 biopharmaceutical companies.
Both Spears and Klassmeier addressed the significant First Amendment court decisions in IMS v. Sorrell and Caronia that strongly suggest that the FDA’s “off-label” marketing regulation will have to be reformed to be consistent with the Supreme Court’s position on commercial speech.Some of the liveliest comments came from Spears, who clearly stated that the time had come for FDA to move “beyond the label” and develop a system that enables “factual, data driven information” to be provided by drug companies to physicians. While uncontroversial to those not schooled in FDA marketing regulation, these comments from PhRMA’s lead lawyer suggest that there is widespread agreement among life science companies that the FDA ban on “off-label” marketing should be changed. Among other points, Spears told the audience that FDA deeming some information “off label” simply because it has “promotional intent” was an exercise in sophistry.
A copy of the Spears Blog Post on the FDA Catalyst site contains much more information: http://phrma.org/catalyst/beyond-the-label