Presented by: Edward Basile

WARNING LETTERS FOR ILLEGAL
PROMOTION DURING “FOCUS GROUPS”
• Hemispherx Biopharma received a warning letter
for promoting an investigational new drug at a
teleconference.
• Schering Corporation received a warning letter for
illegal promotional presentations given at
“interactive scientific teleconferences” or “market
research” (i.e., focus groups).
• FDA required Schering to send corrective “Dear
Doctor” letters to all persons who participated in
the programs or otherwise received the violative
message.