What otherwise would have been a minor incident for Takeda has the makings of a WaterGate-style scandal, which, IMHO, should result in some rolling heads at Takeda!
And I think many bloggers in The Pharma Blogosphere would agree.
First, Takeda is caught running reminder DTC TV ads although it is a signatory of PhRMA's Guiding Principles for DTC Advertising. This was reported first on my Pharma Marketing Blog (see "Rozerem Reverts to Reminder TV Ads").
Then, they claimed the ads weren't reminder ads at all (see "Takeda: It Isn't a Reminder Ad --- Wha!!!")!
That was too much for me. So, I sent a complaint to PhRMA. Although I did get a "thank you for your comment" letter in the return mail (see "PhRMA Responds to My Rozerem Ad 'Concern'"), it didn't seem to deter Takeda.
In a weird twist to the story, FDA, in a "Notice of Violation" (NOV) letter to Takeda, agreed with Takeda that some of these reminder ads are not reminder ads. In fact, says the FDA, specific "Back to School" Rozerem ads violate FDA regulations.
This story was picked up by the newswire, of course, reported in the Wall Street Journal and subsequently in blogs in this space. See, for example:
- "Back to School for Takeda, Rozerem, and Abe Lincoln!" (Pharma Marketing Blog)
- "Why Johnny Can't Sleep: No Rozerem!" (Pharmalot)
"Our preliminary review of the situation indicates that no one internal to Takeda was involved in the approval, release or broadcast of the advertisement in question."This was in an email sent to Jim Edwards of BrandweekNRX (see "Takeda Borrows Cephalon's Excuse for FDA Warning Letter").
This is a literally incredible excuse, never before heard in the annals of the highly regulated pharmaceutical industry. As Rich Meyer over at World of DTC Marketing said:
"Uhhh..you really expect the FDA to believe that and if it is in fact true then Takeda has a hell of a lot more to worry about than an NOV, your business processes are in a serious need of a colonoscopy and someone needs to be held accountable. Frankly in today's business environment this is unacceptable and totally unacceptable for a highly regulated industry like prescription drugs." (See "Rozerem bitch slapped by the FDA").Yes, but don't hold your breath for any accountability. Here are three events we are not likely ever to see:
- Hell freezing over
- Resignation of FBI Director Robert Mueller who claims to be accountable for major violations of the Patriot Act
- Takeda holding itself accountable for its DTC ad campaigns