THIRD EXAM STUDY GUIDE:

FDA Regulations

• What is the FDA definition of prescription drug?
   
  
• Why does the FDA label all new drugs as prescription drugs?
   
  
• The FDA has the jurisdiction to regulate what? How does that include brochures and pamphlets promoting the product?
   
  
• Making claims that have not been approved by the FDA can result in what?
   
  
• What are the FDA guidelines for video, audio and print releases?

• Which federal statute influences these guidelines?
   
  
• What is the "brief summary"?
   
  
• Print advertisements must include the brief summary, which generally contains what?
   
  
• Broadcast ads must contain the "major statement," which contains what?
   
  
• What is the "adequate provision" requirement?
   
  
• What does the FDA presume about consumer-direct broadcast advertisements for prescription drug and biological products?
   
  
• Understand the acceptable approaches to meeting the "adequate provision" requirement, including the use of:
  • Toll free numbers:
     
    
  • Mechanisms to provide package labeling to consumers with restricted access to sophisticated technology, such as the Internet, and those who are uncomfortable actively requesting additional product information or are concerned about being personally identified in their search for product information.
     
    
  • When is the alternative of providing brochures likely to be feasible?
     
    
  • Web site
     
    
  • Referrals to pharmacists, physicians (or other healthcare providers), or veterinarians (in the case of animal drugs)
  
   
  
• What are the criteria for a telephone advertisement?
  
   
  
  • Why and how are telephone advertisements treated differently regarding the adequate provision requirement?
  
   
  
• What are the requirements and encouragements regarding the use of foreign languages and English?
   
  
• The FDA encourages sponsors who use the adequate provision mechanism to collect what and to do what?

• What does DTC stand for?
   
  
• What health-related positives come from DTC ads for prescription drugs?
   
  
• Which FDA division is responsible for regulating prescription drug promotion? What is its mission? How is that mission accomplished?
   
  
• The bulk of the Agency's time is spent reviewing what kinds of promotional material sent to whom?
   
  
• Understand the three types of ads used to communicate with consumers. Which two are regulated by the FDA?
   
  
• Can the FDA generally require that prescription drug advertisements be reviewed and approved prior to their use?
   
  
• What are the FDA's basic remedies and regulatory tools for unlawful advertising?
   
  
• Why do the majority of sponsors voluntarily seek prior comment from FDA on draft broadcast ads for their products?
   
  
• Which materials are flagged for expedited review or are more likely to have extensive reviews?
   
  
• The FDA uses Warning Letters and untitled letters that are more clearly designed to serve as a basis for what?
   
  
• When are untitled and Warning Letters used? Warning Letters usually result in what?

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