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DTC Risk Communication
Is More or Less Needed?

The withdrawal of Vioxx from the market and safety concerns about other Rx drugs has ushered in a new era of benefit-risk analysis for brand name drugs.

The FDA, for example, has a new mandate to review and communicate drug risks and in March, it hosted the inaugural meeting of its Risk Communication Advisory Committee, which is designed to counsel the agency on how to strengthen the communication of risks and benefits of FDA-regulated products to the public.

With all the new attention being paid to drug risks, it is time to take a look at the issues surrounding drug risk communication to consumers and patients. Pharmaceutical marketers need to understand these issues to better communicate risk and build trust in their brands.

This article presents highlights from a panel discussion entitled "Communicating Risk: Key Issues at Hand" that took place during a recent industry marketing conference. This panel considered several issues, including:
  • Clarifying what is meant by risk
  • Pharma's responsibility to communicate risk under the "learned intermediary doctrine"
  • FDA's emergibg risk communications program
  • The concept of hazard vs. risk and its relationship to risk communication
  • New ideas for communicating risk

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PMN74-01
Issue: Vol. 7, No. 4: April 2008
Word Count: 3492

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