FDA BRIEF: Week of August 14, 2017


Be Smart About Prescription Drug Advertising: A Guide for Consumers

Content of Risk Information in the Major Statement in Prescription Drug Direct-to-Consumer Broadcast Advertisements

Prescription Drug Advertising regulations require direct-to-consumer (DTC) advertisements with product claims include information on  major side effects and contraindications

  • Called the major statement
  • Also provide adequate provision for dissemination of approved package labeling
  • FDA issued Guidance

FDA interested in ensuring advertisements provide clear and useful information

  • Concern that major statement not fulfilling purpose
  • Too long, minimization of important risk information, therapeutic noncompliance caused by fear of side effects

Office of Prescription Drug Promotion (OPDP), CDER,  investigating effectiveness of a limited risks plus disclosure strategy

  • Limiting  major statement to those that are severe (life-threatening), serious, or actionable
  • Disclosure that  other product risks not included in the advertisement
  • Present fair balance of risk information and avoid misleading presentation on  risk-benefit profile
  • Requesting comments on Federal Register notice

Federal Register notice

FDA In Brief


ZikaNew FDA tools for development and proper evaluation of tests for detecting Zika virus infection

FDA has made available a panel of human plasma samples for regulatory evaluation of serological tests to detect recent Zika virus infection

  • FDA worked with manufacturers to encourage development of diagnostic tests
  • Ensure they were available using Emergency Use Authorization (EUA)

Two primary blood diagnostic tests

  • Nucleic acid tests: Identify infection by confirming  virus’ RNA
  • Serological tests: Identify antibodies produced by body’s immune system upon Zika detection
  • Development of tests challenging because Zika antibodies produced by the body difficult to differentiate from other related virus antibodies (dengue, West Nile)

FDA’s sample panel

  • Plasma samples from individuals infected with Zika, West Nile, or dengue
  • Diagnostic developers use to check if test can distinguish Zika vs. others
  • Also use to compare test vs. other Zika tests approved via EUA
  • Available to developers who have interacted with the FDA through the pre-EUA process and have devices in final stages of validation

READ


Image credit: FDA

 

 

 

 

 

 

 

 

 

 

 

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