FDA BRIEF: Week of August 14, 2017
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
New 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
Image credit: FDA