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U.S. Department of Health and Human Services

Advisory Committees

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Discussion Topics for the Aug. 16, 2013 Meeting of the Risk Communication Advisory Committee

Our August 16th meeting will have FDA presenting information and questions to the Committee that will help guide conversations and elicit recommendations for the FDA’s efforts to communicate effectively with stakeholders about the risks posed by counterfeit and unapproved drugs, and encourage safe purchasing practices.

Listed below are the agency’s proposed questions for the committee. Where relevant, examples or links are provided to briefly describe or illustrate the discussion topic or key concepts that may assist the committee in better understanding some of the agency's perspectives and challenges. More information will also be shared during the FDA’s presentations.

Discussion Questions:

Physician Awareness Letters

  • How can we best measure effectiveness and impact of these awareness letters?
  • Do the letters to the medical practitioners clearly articulate our communication objectives and make clear our expectation for action?  If not, how can we improve our letter to best express our expectations?
  • What are the best methods to quantify unexpected outcomes caused by issuing the doctor letters?

CDER Alerts

  • How can we best measure the effectiveness and impact of our public health alerts?
  • How do we identify which segments of the populations are listening to our messages, and how do we better understand the effects of the messages on sub-populations (focus healthcare providers vs. consumers)?   
  • Do the alerts clearly articulate our communication objectives and make clear our expectation for action?  If not, how do we improve the alerts?
  • What are the best methods to quantify unexpected outcomes caused by issuing the alerts?
  • What are the best ways to measure or determine whether stakeholders are enhancing our message to the public or their constituents?

Broadening communication vehicles

  • What resources do you think (i.e., websites, newsletters, blogs) do medical professionals utilize to keep abreast of current issues/trends in the medical community that we would be able to utilize to reach them?
  • Based on the current stakeholder and target audiences that we already work with, could the committee recommend innovative communications vehicles to distribute our message for greater impact.  Are there target population specific vehicles that should be utilized?

Communication to FDA

  • How can FDA learn about stakeholder (healthcare providers, associations, etc.) barriers to communicating with the agency about suspect products or sellers? 

Influencing behavior change

  • What are some best practices associated with incentivizing certain behaviors over others- and specific to healthcare providers, can the committee recommend ways to encourage safe drug purchasing practices?
  • How can we encourage regulatory bodies (i.e. state boards of medicine or pharmacy) to utilize their authority against bad actors that hold a license in their state (drug distributors or doctors)?
  • How can we effectively engage payers on this issue?