Regulatory Focus™ > News Articles > Study Supporting Daiichi Promotional Materials Pummeled by FDA in New Untitled Letter

Study Supporting Daiichi Promotional Materials Pummeled by FDA in New Untitled Letter

Posted 11 November 2013 | By Alexander Gaffney, RAC

An Untitled Letter sent by the US Food and Drug Administration (FDA) to Daiichi Sankyo regarding promotional materials for two formulations of its hypertension drug Benicar alleges that the materials are misleading and make the drug appear to be more effective than it actually is.

The 5 November 2013 letter was sent by FDA's Office of Prescription Drug Promotion (OPDP), and refers to a single advertising piece that co-promotes Benicar (olmersartan medoxomil) and Benicar HCT (olmersartan medoxomil/hydrochlorothiazide) tablets.

The drugs are FDA-approved for use in treating hypertension either as monotherapy or as adjuncts with other antihypertensive products. Benicar HCT, however, is not intended for first-line treatment.

Both contain Boxed Warnings as part of a Risk Evaluation and Mitigation Strategy (REMS) program reflecting the potential for fetal toxicities and adverse events in diabetic patients on aliskiren therapy, as well as a long list of other contraindications, warnings and precautions in various patient groups.

However, when OPDP reviewed Daiichi's direct mail piece, they said they found a number of statements that were not supported by either the drug's currently approved indication or substantial evidence. At the core of FDA's complaints was a claim by the company that its products helped "seven out of ten challenging patients reach goal."

The problem, FDA said, was that the referenced study was an open-label, uncontrolled trial that excluded challenging patients, "and therefore did not properly evaluate this subgroup." Regulators contended that the lack of either substantial evidence or substantial clinical experience was therefore misleading, causing the drug to be misbranded as a result.

The Untitled Letter-less serious than a Warning Letter in that it does not threaten further enforcement action, but still a stern warning from regulators-goes on to request that Daiichi Sankyo "immediately cease the dissemination of the violative materials" for the two drugs and respond by 19 November 2013 regarding its plans to comply with FDA's request.

FDA Untitled Letter to Daiichi Sankyo

Promotional Material

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