OPDP Picks Up Steam on Enforcement Letters

After a fairly slow 2016, the United States Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued a quick burst of letters in the span of nine days in December. This flurry of activity more than doubled the enforcement letters that had been issued up to that point in the year. Although there was an apparent increase in enforcement activity in December (perhaps related to the new Administration and the mark the old Administration wanted to leave on the industry), the type of activity and the nature of Draft Guidances issued in 2017 prior to the Trump Administration taking office indicated a dramatic shift in OPDP’s approach from years past. After losing battle after battle in First Amendment cases, OPDP seems to be using more discretion when it comes to enforcement letters, focusing instead on omission and minimization of risk, as well as pre-approval promotion. The FDA’s First Amendment case losses tended to focus on issues relating to information disseminated about FDA-approved or FDA-cleared prescription products, not addressing communications about investigational products for which there were no approvals or clearances. Of the 11 letters issued in 2016, four dealt with pre-approval promotion. Given that only four of the 70 total letters issued by OPDP between 2012 and 2015 dealt with pre-approval promotion, this dramatic increase signals a potential sign of things to come in terms of OPDP’s future enforcement activities. ...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs