The U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently released the third untitled letter in 2018 to focus on efficacy claims for approved products, after largely refraining from issuing such letters since successful challenges to the agency’s authority over prescription drug promotion in 2015. Together, these letters suggest that OPDP has resumed enforcement in this area, having taken steps to clarify what is (and is not) considered an “off-label” use and having adjusted its approach to include explicit analysis of why any particular efficacy presentation is false or misleading and presents a particular risk to patients.
The lull in enforcement traces back to FDA’s loss of a significant First Amendment challenge to its authority to restrict truthful and non-misleading promotion of off-label uses,1 and another legal challenge that led to FDA rescission of a warning letter related to alleged off-label promotion. According to FDA, the letter was issued in error because it was based on an “ambiguity with respect to the scope of the approved indication.”2 Since these events, OPDP has issued relatively few letters, and its overall approach has focused on inadequate communication of risk information and pre-approval promotion of investigational drugs.
The three recent letters were based on efficacy-related presentations that OPDP alleged were false or misleading, and, although one of them is heavily redacted, it appears that all three letters included significant discussion of the basis for that allegation.3 In two of the letters, OPDP also included justification for additional allegations that the relevant claims were especially concerning from a public health perspective.
The most recent letter is noteworthy because it represents the first OPDP letter since 2016 with an allegation related to off-label promotion,4 and comes shortly after FDA finalized a new guidance intended to help manufacturers determine when and how information not found in the FDA-approved labeling may be presented in promotion because it is considered “consistent with” the FDA-approved labeling, or “CFL.”5 (This has also been called “out-of-label” information, as opposed to “off-label” information.)
One of the other recent letters is also noteworthy because it was premised in part on failure to adequately communicate important contextual information for an efficacy claim. There, OPDP focused on claims about abuse deterrence technology for an opioid product, which were prominently presented at eye level on an exhibit booth panel. OPDP alleged that the presentation was misleading because important information about the limitations of this technology in preventing abuse was presented at the bottom of the panel, near the floor and obscured by a table and chair.
Taken together, the letters suggest that FDA is once again pursuing enforcement against off-label and other efficacy claims, at least where such claims pose a particular risk to patients and are demonstrably false or misleading. This includes scenarios where an efficacy-related presentation is allegedly misleading because important contextual information is not prominently presented.