FDA Bad Ad Program Overview
 

FDA Bad Ad Program Overview

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A high level overview of FDA's Bad Ad Program

A high level overview of FDA's Bad Ad Program

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    FDA Bad Ad Program Overview FDA Bad Ad Program Overview Presentation Transcript

    • The FDA’s Truthful Prescription Drug Advertising and Promotion (“Bad Ad”) Program
    • The role of DDMAC
      FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) aims to ensure that all prescription drug promotion is truthful, balanced, and accurately communicated. Promotions it regulates include
      Sales representative presentations
      Speaker program presentations
      TV and radio advertisements
      All written or printed drug promotional materials
      Source: FDA website http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm211791.htm
    • DDMAC enforcement efforts
      Traditionally, DDMAC has monitored prescription drug promotions through
      Review of promotional materials submitted by companies
      Investigation of complaints about drug promotions
      Close observation (surveillance) of drug promotions at large medical conventions
      Review of promotion using the Internet
      Source: FDA website http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm211791.htm
    • Shortcomings of current system
      Under the current system, lack of access has limited DDMAC’s ability to monitor promotional activities that occur in settings such as
      Physicians’ offices
      Local dinner programs
      Promotional speaker programs
      Source: FDA website http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm211791.htm
    • Increasing the effectiveness of DDMAC's surveillance program
      Truthful Prescription Drug Advertising and Promotion (“Bad Ad”) Program
      The program is designed to improve DDMAC’s ability to regulate promotional activities to which it historically has had limited access
      The program will help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency
      The FDA will implement an educational outreach program designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading
      Source: FDA website http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm
    • What the FDA is asking physicians to do
      Recognize and report
      According to the FDA, the prescriber can play an important role in ensuring that prescription drug advertising and promotion is truthful by recognizing and reporting misleading drug advertising and promotion
      Recognize
      The FDA is asking physicians to be aware of the many advertisements and promotions that they see every day
      Report
      The FDA is asking physicians to help stop violations by reporting activities and messages that they consider false or misleading
      Source: FDA website http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm
    • Educating physicians on their role
      DDMAC will have a booth at some of the major medical conferences starting in May of 2010
      DDMAC reviewers will be speaking with prescribers regarding how to recognize misleading prescription drug promotion and how to report any potential violations to the FDA
      In-service training sessions with large group practices and hospitals are also available
      Source: FDA website http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm211498.htm
    • Reporting a violation
      Violations can be reported by phone, fax, e-mail, or written letter
      Complaints can be filed anonymously
      Complaints will be reviewed by a Regulatory Review Officer responsible for the class of drugs being reported to ascertain if a violation has taken place and, if so, what the appropriate course of action is
      Source: FDA website http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm
    • Questions about the program
      Will doctors be able to recognize a violation?
      Many doctors will not be able to attend FDA-led training sessions
      Does the FDA have the resources to follow up on reports effectively?
      If there are a large number of reports, the FDA does not have the manpower to address them
      Will the anonymous reporting system be misused?
      Physicians who dislike reps, competitors trying to trash each other, and individuals frustrated with the healthcare systems could potentially file unfounded complaints