Presented by: Edward Basile

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WHAT ARE THE CONSEQUENCES OF ILLEGAL PROMOTION • Illegal promotion is a violation of the FFDCA and subjects the responsible company and individuals to certain sanctions: – Criminal Prosecution – Criminal Fines – Injunction – Warning Letter – Untitled Letter
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.
Page 1 and 2: Presented by: Edward Basile
Page 3 and 4: THE FDC ACT’S DEFINITION OF LABEL
Page 5 and 6: FDA AUTHORITY OVER LABELING AND ADV
Page 7 and 8: FDA AUTHORITY OVER LABELING AND ADV
Page 9 and 10: PRE-APPROVAL PROMOTION (con’t) Dr
Page 11 and 12: PRE-APPROVAL PROMOTION (con’t) De
Page 13 and 14: OTHER PRE-APPROVAL ACTIVITIES (con
Page 15 and 16: MANUFACTURER INVOLVEMENT IN CONTINU
Page 17 and 18: CONTINUING MEDICAL EDUCATION (con
Page 19 and 20: PRESS RELEASES • Product-specific
Page 21 and 22: INFORMATION ON THE INTERNET • Inf
Page 23 and 24: INFORMATION ON THE INTERNET (con’
Page 25: ENFORCEMENT OF PROMOTION AND ADVERT

Presented by: Edward Basile

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