FDA: Takeda Ad for Velcade Was Not Funny Enough

The FDA has warned Takeda's Millenium Pharma unit that utilizing a double entendre in a reminder ad is a violation of drug marketing law.

The warning letter will be carefully noted by drug marketers, their copywriting agencies and compliance departments as another restriction on their creativity. It also comes as yet another indication that the FDA wants reminder ads to be used a strictly as possible. Reminder ads are promotions where only the name of the drug is shown and no medical claims are made. PhRMA's guidelines for direct-to-consumer advertising bans them on TV but not to professionals.

The FDA's warning letter says that marketing for cancer drug Velcade was "not appropriate" and "false or misleading" because it used the phrases "Achieve a Complete Response" and "Your Complete Response Matters." The "joke" is that the company was asking doctors attending the ASCO cancer conference for a "complete response" to their ad in exchange for Millenium making a donation to a cancer charity. Not funny enough, the FDA said:

The term "CR" or "complete response" is widely known and understood in the oncology community to mean the disappearance of all detectable signs of cancer in response to treatment; ...

... the existence of this second meaning for the term does not make its use appropriate in a reminder piece given that its primary meaning in the oncology setting makes representations or suggestions about the drug.

The totality of these presentations misleadingly suggests that patients treated with Velcade therapy are likely to achieve a complete hematological or clinical response. However, as described in the Clinical Studies section of the PI approved at the time this piece was disseminated, only 6% (20 out of 315 patients) of Velcade-treated patients achieved a complete response in the Phase 3 clinical study.