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Overview of Activity: October 2012-September 20<strong>13</strong> § CDER/Office of Prescription Drug Promotion (OPDP): § 1 Warning Letter § 18 Untitled Letters § 2 letters noted offending materials were picked up by FDA personnel at conferences § CBER Advertising and Promotional Labeling Branch (APLB) § 1 Untitled Letter § OPDP oversees advertising/promotion of therapeutic biologics § 2 of OPDP’s Untitled Letters were for BLAs § Compared to prior years, downward trend in letters, especially in warning letters 2
Trends & Emerging Trends 19 OPDP Letters § Risk information presentations (<strong>13</strong>) § Data from flawed study designs unable to provide substantial evidence for claim (11) § Overstatement of efficacy § Unsubstantiated superiority § Investigational product promotion (3) § Press/news releases (3) § Composite data (1) 3
Page 1: Trends in OPDP Enforcement Letters
Page 5 and 6: Presenting Risk Information: Legal
Page 7 and 8: Agency Guidance Activity § OPDP Di
Page 9 and 10: Examples (in Labeling) (cont.) § S
Page 11 and 12: Presenting Data: Legal Authorities
Page 13 and 14: § Doxil ® Website “In a retrosp
Page 15 and 16: Investigational Drug Promotion § 1
Page 17 and 18: Investigational Drug Promotion Exam
Page 19 and 20: Press/News Releases § Form 2253 id
Page 21 and 22: Examples of Press Releases in OPDP
Page 23 and 24: FDA’s DTC Advertising Composite S
Page 25 and 26: 25 TAKEAWAYS
Page 27 and 28: Closing Takeaways (cont.) § Don’

Slides (Updated 9/13/13)

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