Here Comes the Pitch, He Swings, and a Miss! OPDP Issues Untitled Letter for Media Pitches

By Jeff Wasserstein & Dara Katcher Levy –

FDA’s Office of Prescription Drug Promotion (“OPDP”) recently issued an untitled letter to Cornerstone Therapeutics, Inc. relating to Cornerstone’s drug Curosurf (see here and here).  The allegations in the letter are unremarkable and contain the usual claims that the company failed to provide risk information, made unsubstantiated superiority claims, the likes of which are so standard that we are tempted to just say “yada yada yada.”

What makes this letter noteworthy is that the promotional materials complained about included a letter to the media pitching a story about Curosurf (a “pitch letter”) that included an attached press release.  In our experience, there is often a sense among those in the industry that media pitch letters do not need to meet the same requirements as more traditional promotional materials.  This untitled letter clearly indicates that FDA does not take this position. 

What’s also interesting is that FDA criticized the pitch letter for lacking any risk information associated with the drug, even though the press release that was attached to the pitch letter did contain important safety information.  Companies often look at the totality of a promotional presentation in determining whether there is sufficient fair balance.  With this letter, FDA seemingly rejects the gestalt approach and would require each piece of a promotional presentation to contain adequate risk information. 

Also notable is that this is the second letter posted within the past week that mentions a press release.  In the other instance, the press release related to an investigational product (see here and here).  However, both these letters are notable because FDA letters relating to statements in press releases have been few and far between (other than a letter issued in 2009 relating to a video news release, DDMAC/OPDP has not issued a letter relating to a product press release since 2001).  We also note that Cornerstone submitted the media pitch package including the press release on a Form FDA 2253, as is required for promotional labeling.   Query whether the press release, alone, distributed through normal press release channels (and not submitted on a 2253 as is the practice of many companies) would have triggered a letter.

While it’s too soon to tell if this is an enforcement trend or happenstance, it bears watching and remembering that FDA will consider press releases to be promotional labeling in certain circumstances.