Alan Minsk Quoted in Pink Sheet on OPDP Untitled Letter for Sucraid Promotional Emails

AGG Food & Drug practice chair Alan Minsk was featured in an article for Pink Sheet discussing the latest untitled letter targeting healthcare professional (“HCP”) promotional emails sent by FDA’s Office of Prescription Drug Promotion (“OPDP”).

“OPDP historically has not raised many concerns about emails,” Alan said. “Short promotional pieces often will include an abbreviated indication in the main text with the full indication in the ISI further down.”

Alan noted that the letter carries a broader message, “However, OPDP is reminding industry that, if the text font and prominence are such that the ISI information is so minimized in comparison, the overall messaging can be problematic and potentially misleading.”

“Furthermore, claims highlighting conditions that share symptoms with the indicated disease or contributing factors of the disease can be misleading and imply uses beyond the approved indication,” he added. “OPDP emphasizes here that the approved indication must be clear.”

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