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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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  • 1. The FDA’s Truthful Prescription Drug Advertising and Promotion (“Bad Ad”) Program
  • 2. 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
  • 3. 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
  • 4. 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
  • 5. 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
  • 6. 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
    The FDA is asking physicians to be aware of the many advertisements and promotions that they see every day
    The FDA is asking physicians to help stop violations by reporting activities and messages that they consider false or misleading
    Source: FDA website
  • 7. 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
  • 8. 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
  • 9. 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