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Public hearing to address drug-safety information

Pharmacy Regulation Resource, October 5, 2005

The FDA Center for Drug Evaluation and Research (CDER) will hold a public hearing to discuss the center's current risk communications and outreach strategies at the National Transportation Safety Board Boardroom and Conference Center in Washington, DC, on December 7-8.

The FDA seeks to obtain input on CDER's risk-communication tools, identify stakeholders for collaboration and implementation of additional tools, and obtain an understanding of the strengths and weaknesses of CDER's current risk-communication strategies, according to a press release.

Current communication tools include patient information sheets, healthcare professional information sheets, public health advisories, press releases, the MedWatch listserv safety updates, Patient Safety News, CDER educational campaigns, and the CDER Web site, www.fda.gov/cder/index.html.

The FDA and CDER intend to ask the following questions:

• Do these tools provide the right kind and amount of risk and
  other information that healthcare professionals need to make informed decisions about whether to prescribe drug products?
• Do these tools provide what the public needs to make informed decisions about whether to use those products?

Those planning to participate in providing oral comments must register by November 7. For more information or to register, visit www.fda.gov/cder/meeting/RiskComm2005/default.htm.

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