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Drug Safety Oversight Board Meeting: September 14, 2006 Public Summary

  • The Executive Director updated the Board on Public Health Advisories (PHAs) posted since the last meeting, including the Triaminic Vapor Patch, selective serotonin reuptake inhibitors (SSRIs) and information on treatment challenges of depression in pregnancy, and a drug combination, SSRIs and triptans, that may result in serotonin syndrome. New PHAs and other safety information were announced through MedWatch and also under News at: CDER's home page.
  • The Board received updates about ongoing topics for which internal CDER working groups had been formed. First, a group charged with following up on issues discussed in sheets and a PHA posted about fentanyl patch products reported on their ongoing discussions. The next working group reported their review of the issues surrounding the use of information sheets for healthcare professionals and patients/consumers for nonprescription products, especially those covered by drug monographs.
  • The Board reviewed the draft revised guidance on communicating safety information (previously issued for comment in May, 2005 under the title, Draft Guidance: FDA’s “Drug Watch” for Emerging Drug Safety Information).
  • The Board heard a presentation from the Director of the Office of Surveillance and Epidemiology about the new electronic system that had been implemented for managing that office’s work.
  • The Board discussed the topic of how best to educate healthcare professionals and consumers about the role and clinical utility of pharmacogenomic testing, and conditions under which various communication tools should be employed. Given the complexity and importance of this topic, it was agreed that further discussions should be held at the next Board meeting.
  • The Board received reports from two CDER Process Improvement Teams (PITs) that have been working for over a year on improving the way safety issues are handled and on strengthening internal communication and accountability for these issues. The Board agreed that these processes and procedures will help to promote timely, regular collaboration between OND and OSE on safety issues. The Board also heard a presentation on the status of the development of and progress toward implementing a Safety Tracking System for the Center. The teams were congratulated for their work.