Quiz On FDA Regulation Of Pharmaceutical Marketing And Promotions

10 Questions | Total Attempts: 1146

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Quiz On FDA Regulation Of Pharmaceutical Marketing And Promotions

This short quiz was developed to help you test your knowledge of current FDA regulations concerning the marketing and promotion of pharmaceuticals. Take a few minutes to answer the questions and score yourself. If you receive a perfect score, please let us know via the "comments".


Questions and Answers
  • 1. 
    Prescription drug advertising and promotional labeling is governed by which of the FDA Center for Drug Evaluation and Research (CDER) offices listed below?     
    • A. 

      Office of New Drugs

    • B. 

      Office of Prescription Drug Promotion (OPDP)

    • C. 

      Office of Drug Security, Integrity and Recalls

    • D. 

      Office of Unapproved Drugs and Labeling Compliance (OUDLC)

  • 2. 
    2. What types of prescription drug promotion does the FDA regulate?    
    • A. 

      TV and radio advertisements

    • B. 

      All written or printed promotional materials

    • C. 

      Speaker programs and sales representative presentations

    • D. 

      All of the above

  • 3. 
    3.  A prescription drug advertisement must:   a.) not be false or misleading b.) be consistent with the approved labeling and package insert c.) only include information that is supported by strong evidence d.) all of the above
    • A. 

      Not be false or misleading

    • B. 

      Be consistent with the approved labeling and package insert

    • C. 

      Only include information that is supported by strong evidence

    • D. 

      All of the above

  • 4. 
    4. There are 3 main categories of prescription drug advertisements, which is NOT one      of them?    
    • A. 

      Product claim ad

    • B. 

      Physician-endorsed ad

    • C. 

      Reminder ad

    • D. 

      Help seeking ad

  • 5. 
    Prescription drug advertisements that contain “product claims” must provide     reasonably similar content about a drug’s risks and benefits. This requirement is     generally referred to as:      
    • A. 

      Mirror image rule

    • B. 

      Tit for tat

    • C. 

      Fair balance

    • D. 

      Mix and match

  • 6. 
    A common marketing violation occurs when a pharmaceutical sales representative encourages a physician to prescribe a drug for an unapproved use. This is commonly known as:  
    • A. 

      Black label marketing

    • B. 

      Off label marketing

    • C. 

      No label marketing

    • D. 

      New label marketing

  • 7. 
    An ad sponsor distributes a patient brochure for Drug X, which contains the following     text, “Drug X generally produces little or none of the restlessness, stiffness, shakiness,     or tremor you may have experienced with other medications.” If no comparative     clinical study was performed, the brochure statement is misleading because it is a:    
    • A. 

      Broadening of indication claim

    • B. 

      Omission of risk claim

    • C. 

      Unsubstantiated superiority claim

    • D. 

      Overstatement of efficacy claim

  • 8. 
    In 2010, the FDA launched this program to encourage physicians to recognize and     report untruthful or misleading prescription drug promotion.   Bad Ad program Bad Drug program Bad Rep program Bad News program  
    • A. 

      Bad ad program

    • B. 

      Bad drug program

    • C. 

      Bad rep program

    • D. 

      Bad news program

  • 9. 
    If a pharmaceutical advertisement is in violation of the law, the FDA can initiate     enforcement actions, which include:  
    • A. 

      issuing a Untitled Letter, which notifies the ad sponsor of the marketing violation

    • B. 

      Issuing a Warning Letter, which may require the ad to be discontinued

    • C. 

      Order the ad sponsor to disseminate a corrective advertisement

    • D. 

      All of the above

  • 10. 
    In this recent, Landmark court case, an Appellate judge overturned the conviction of a       pharmaceutical sales rep, ruling that his “off-label” promotion is protected by the       1st Amendment, freedom of speech.   c.) United States v. Caronia d.) United States v. Ben Venue Laboratories, Inc.  
    • A. 

      United States v. Dotterweich

    • B. 

      United States v. GlaxoSmithKline PlC

    • C. 

      U.S. vs. Canada

    • D. 

      U.S. vs. Ben Veue Laboraories

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