sábado, 19 de agosto de 2017

FDA requests feedback regarding the content of risk information in direct-to-consumer (DTC) broadcast advertisements for prescription drugs.

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)
Today, the Food and Drug Administration (FDA) in a Federal Register notice announced the availability of a public docket to assist with its development of recommendations regarding the content of risk information in direct-to-consumer (DTC) broadcast advertisements for prescription drugs.

The FDA helps to ensure that when firms choose to advertise prescription drugs directly to consumers and patients, such advertisements provide useful information to that audience, including information about a drug’s risks presented in the “major statement.”  There is concern that the major statement, as currently implemented in DTC broadcast ads, is not fulfilling this purpose.  Therefore, FDA is exploring the usefulness of limiting the risks in the “major statement” to those that are severe (life-threatening), serious, or actionable, coupled with a disclosure to alert consumers that there are other product risks not included in the advertisement.  

As previously announced, FDA is investigating through empirical research the effectiveness of this “limited risks plus disclosure” approach to the presentation of risk in the major statement to help inform the Agency’s decision making in this area.  FDA invites interested stakeholders  to provide detailed information and comments on the disclosure of risk information in DTC broadcast advertisements for prescription drugs.  FDA has also outlined questions of particular interest, including those related to:  
  • Available data on current approaches of risk information communication and consumer comprehension of risk information
  • Effects of only including certain risks (severe, serious, actionable) and ways to characterize included risks
  • Options for including language on other types of risks
  • Criteria for identifying risk information that is most material to the patient/consumer versus to the healthcare provider
  • Criteria for determining which of the material risk information to include in the major statement
  • Effects of including (or not including) disclosure language with a limited risk presentation to alert consumers that there are other risks not included in the advertisement
  • Availability of data regarding consumers’ comprehension of different levels (i.e. severity) of risk information
  • Considerations related to identifying and disclosing potential food and drug interactions.
Please see the FDA In Brief for a comment by the FDA Commissioner. More information is available in theFederal Register notice on how to submit feedback on the content of risk information in DTC broadcast advertisements for prescription drugs.

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