Additional Untitled Letters Issued by OPDP

It has been a rather extraordinary month for watchers of the Office of Prescription Drug Promotion (OPDP) in that while the office has issued very little enforcement during the bulk of the year, December has been making up for it. So far this month, there have been a total of 6 letters issued, 1 more than for the entire combined effort during the 11 months preceding December. And this month, they have come in batches of two.

As we have seen of late, both of the most recent letters issued on December 21 were sent to companies that fall outside of the top fifty pharma companies. Both letters involved videos posted to YouTube and both involved a single violation – the promotion of an investigative drug without FDA marketing authorization.

While the circumstances of the two letters bear those similarities, there are also differences. The first letter involves and investigative treatment for diabetic dyslipidemia and hypertriglyceridemia. OPDP cites claims in the video regarding the mechanism of action, claims about the benefits and that the compound “ushers in a new era”. In addition, there is a statement that the compound is indicated for its investigative purpose.

The second letter involves a compound that had already received a complete response letter (CRL). That is noteworthy because normally the agency does not reveal the contents of a CRL but in this case the company in question issued a press release which the agency did quote to say that the agency was looking for an additional clinical trial to firmly establish efficacy. In the video, OPDP cites direct statements made that are quite direct about the investigational compound being shown in trials to be safe and effective.

The central point related to violations involving the promotion of an investigative compound is to avoid statements in communications that imply either directly or indirectly that such a drug is either safe or effective. While the fact that both of these violations occurred on YouTube might reinforce a notion that social media platforms are inherently high risk, the violations would have been violations regardless of the communications platform. That said, it does bear noting that looking back through 2004 at the letters that have been issued by the office for promotion of an investigational compound, the overwhelming majority have been on digital platforms (mostly websites).

Most of us are on holiday hiatus and if you are one of them, I hope you are enjoying the holidays. In the meantime, given that Warning and Untitled letters often have a delay in being posted to the FDA site, we will hold off on a review of the entire year until after January 1. In the meantime, Happy New Year to one and all.

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