Warning and Untitled Letters and Spoken Words

Pulling on my database on Warning and Untitled Letters over the past ten years, I had occasion to look up those violations over the past 10 years that involved the spoken word. The database profiles each letter and tracks various characteristics – from company to drug to indication to type of letter (Warning or Untitled) and many more fields.  One of the categories tracked is the communications vehicle that conveyed the message found to be in violation by the Office of Prescription Drug Promotion.

Of the now 284 letters in the database, 12 involved the use of spoken word as the communications vehicle involved in a violation.  One interesting point to note – while a number of disease areas were involved, drugs addressing mental and behavioral conditions were the subject of four (33 percent) of the letters – 2 in schizophrenia, 1 in ADHD and 1 antipsychotic.

Under what circumstances were statements made?  One might suppose that the most common means for an oral statement to result in a violation would be during a visit from a sales representative – and one would suppose correctly.  But while common, that circumstance was involved in only 6 of the letters – so perhaps it is not as common a cause as one might be inclined to think.

Three of the violations involved discussions at a booth during an exhibit at a large medical meeting.  One involved a presentation by a key opinion leader at a lunch meeting. And the final two involved media interviews.

One of those media interviews is well known to “letter watchers” and involved statements made by an investigator in broadcast interviews which resulted in the highly unusual circumstance where the letter was directed to the clinical investigator instead of the sponsor.  The second of the media interviews was quite recent and is notable because it involved the statement of the company CEO doing an interview on a broadcast show directed to investors.

The takeaway here – unlike many other communications vehicles such as a brochure for example – use of oral statements in any capacity is a vehicle where the sponsor lacks a degree of control.  You can direct what goes into print, it is more difficult to direct what someone is going to say in every circumstance.  That emphasizes the need for really thorough training and practice for spokespeople regarding the parameters of regulated speech – those at all levels – from sales rep to researcher to CEO, especially in the setting of a wide-ranging media interview.

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