On June 6, 2014, FDA granted (see full response here) a series of Citizen Petitions submitted by the Medical Information Working Group (“MIWG”) in 2011 and 2013 requesting clarification of the agency’s position on drug and device manufacturer communications concerning investigational products and unapproved uses of approved products. MIWG asked the agency to comprehensively review its regulations and policies in light of recent First Amendment case law, including the Sorrell and Caronia cases. In its response to the petitions, the agency stated that it has already addressed many of the specific issues raised by MIWG in recent guidance on unsolicited requests (2011), social media (2013), and reprints, reference texts, and clinical practice guidelines (2014). The agency also issued a call for comment on the scope of “scientific exchange” in December 2011. In addition to these initiatives, FDA reported that it plans to issue two new guidance documents before the end of 2014 – one addressing unsolicited requests, distributing scientific and medical information about unapproved new uses, and manufacturer discussions concerning scientific information more generally, and another on health care economic information.
