The QMN Weekly Bulletin

Daiichi Sankyo Receives Untitled Letter for False Efficacy Claims

Nov. 15, 2013

The FDA has handed Daiichi Sankyo an untitled letter for making claims in a brochure that two of its hypertension treatments helped lower blood pressure in patients with severe hypertension, despite a lack of substantial supportive evidence.

In a mailing to physicians promoting Benicar (olmesartan medoxomil) tablets and Benicar HCT (olmesartan medoxomil-hydrochlorothiazide) tablets, the drugmaker reported results from an open label, uncontrolled trial. However, FDA cited three reasons why the promotion failed to satisfy requirements for efficacy claims:

  • The trial lacked placebo control or blinding;

  • The trial it cited excluded patients with severe hypertension; and

  • The mailer featured a bar graph that depicted a greater reduction in blood pressure than was actually seen in the clinical trial.

The agency is asking Daiichi Sankyo to stop distributing the mailer. The company said it has complied with the request.

“Daiichi Sankyo is currently reviewing the contents of the letter and will work to quickly identify any other marketing pieces that may include a similar representation of this data,” spokeswoman Alyssa Dargento said. “The piece in reference was a one-time distribution and is no longer given to physicians.”

The untitled letter to Daiichi Sankyo is the 14th untitled letter issued by the FDA this year. At this time last year, the agency had already issued 23 such letters.

Learn how to avoid that next enforcement letter from the FDA, be it an untitled letter, a warning letter or a complete response letter, with FDA Complete Response Letter Analysis: How 51 Companies Turned Failure to Success: Order now.