- March 01, 2019
What’s different about the FDA’s latest untitled letter? It involves words spoken by a sales rep. It marks only the 14th time a Warning or Untitled Letter has involved an oral statement, said Mark Senak, a Public Relations professional and Eye on FDA blogger. The last time a sales rep was involved was in 2012, according to his database of 329 letters dating back to 2004.
Exactly what the Eisai sales rep said is unclear, as much of the explanation of the offense is redacted in the letter. However, the letter did note that the tip came from the FDA’s Bad Ad program and in this case seems clearly to be from someone who was in the room during the Eisai rep’s presentation.
Senak noted that this letter and another recent letter both came through the Bad Ad program, which encourages healthcare professionals to report instances of misleading drug promotion with a direct phone call or email to the FDA’s Office of Prescription Drug Promotion (OPDP). “For anyone who thought Bad Ads was a dormant program, it apparently is not,” Senak said via email. “The message to sales reps is that docs are listening and docs are reporting and when they do, the FDA may act.”
When asked if the sales rep letter might have a chilling effect on rep speech, Senak said he does not think so. He noted that reps already go through training about communications boundaries and the letter does not send any new messages in that regard.
The Eisai letter brings the total of OPDP enforcement letters for 2018 up to six (6), a tally that is pulled ahead of 2017’s total of five (5) letters. Letters have been on the decline over the past several years, although the agency sent 11 in 2016 and nine (9) in 2015. Still, Senak thinks those in healthcare communications should “…sit up and take note…” after the latest letter, he wrote in a recent column.
“While OPDP has been less active on the enforcement front, the letters this week demonstrate that when the agency receives complaints via the Bad Ad program, it will act on them, particularly where… it believes there is a safety issue — which may be more pronounced when a product has a boxed warning,” he said.
REFERENCE: Fierce Pharma; 29 OCT 2018; Beth Snyder Bulik