Arizona's Off-Label Promotion Law May Hinge On Gottlieb
By Alexis Kellert, Weil Gotshal & Manges LLPMay 8, 2017, 3:54 PM EDT
Law360, New York (May 8, 2017, 3:54 PM EDT) -- In November, the U.S. Food and Drug Administration announced its decision to collect feedback regarding whether drug and device manufacturers should be allowed to promote their products for uses outside of their FDA-approved treatments (i.e., “off-label”). The mere fact that the FDA sought this type of public input on the issue marked a significant shift in the agency’s enforcement regime, which has prohibited off-label advertising since the mid-1960s.
On March 21, 2017, Arizona became the first state to pass legislation advancing the issue one step further...