Focus on Drug Safety Communication & TV DTC Advertising A Review of Two New FDA Guidance Documents

Drug Safety & DTCThis article reviews two recently published and important guidances from the FDA that concern the dissemination of drug information to consumers.

FDA’s Center for Drug Evaluation and Research (CDER) issued guidance regarding how the agency will classify and communicate drug safety information (“Classifying Significant Postmarketing Drug Safety Issues” and “Drug Safety Information — FDA’s Communication to the Public”).

FDA’s Office of Prescription Drug Promotion (OPDP, formerly DDMAC) issued guidance regarding mandatory review of TV direct-to-consumer (DTC) ads prior to dissemination (“Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad Pre-Dissemination Review Program”).

Topics include:

  • Safety First
  • Not All Safety Issues are Urgent
  • Social Media Implications
  • Mission: Correcting Misleading Information
  • Preview of TV Ads
  • Which Ads Will Require “Pre-dissemination” Review?
  • The 45-day “Shot Clock”
  • What Exactly Will the FDA Review?
  • Pushing the Envelope May Be Too Costly?
  • A Possible Loophole

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Issue: Vol. 11, No. 3
Publication date: 19 March 2012
Word Count: 2,484

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