Hogan Lovells Publications | Pharmaceutical and Biotechnology Alert | 20 January 2017

In The Midnight Hour: FDA Issues 2 Draft Guidances and a First Amendment Memorandum on the Cusp of a New Administration

Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two things through these documents. First, it defines more broadly acceptable claims and evidentiary support for certain forms of promotion and effectively narrows the scope of its past enforcement positions. Second, the Agency simultaneously asserts that strong public health and policy reasons support its long-held position that promotion of an unapproved use of an approved product should remain prohibited.

Click here to read summaries of the three documents and our initial analysis of them.

Download PDF Back To Listing