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Challenges for the FDA The Future of Drug Safety: Workshop Summary (2007) / Chapter Skim
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1 Introduction
Pages 9-12

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From page 9...
... relies on the fees that it receives from the industry it regulates to fund its essential programs. At the same time, the issue of prescription drug safety has received widespread public and congressional scrutiny as a result of the highly publicized recall of the arthritis drug Vioxx because of its link to serious cardiovascular events, and more recently the increased risk of suicidal ideation among children being treated for depression with selective serotonin reuptake inhibitors (SSRIs)
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From page 10...
... (AERS) and expanding safety database resources in an effort to strengthen epidemiological surveillance methods and tools; and employing several Critical Path Initiative*
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From page 11...
... staff in reviews and regulatory decision making, implementing new procedures for postmarket decision making, implementing a postmarket electronic tracking system, establishing a new advisory committee on communication, publishing an Internet newsletter on postmarket findings, and issuing new guidance on risk communication. Improving Operations and Management In its effort to improve its culture of safety throughout the life cycle of the products it regulates, the FDA is reinvigorating the senior management team of the Center for Drug Evaluation and Research and charging it with leading the organization in an integrated manner, enlisting external organizational consultants to address concerns about tensions between preapproval and postapproval staff and clarify their respective roles and responsibilities, and improving the way in which scientific disagreements are handled.
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From page 12...
... It should be noted that, while the IOM report suggested some organizational and cultural changes at the FDA, those recommendations were not a focus of the discussions during the symposium. Additionally, participants did not deliberate upon whether the FDA in its current form is properly configured to lead the efforts that were discussed.
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Key Terms

  • prescription drug
  • postmarket safety
  • postmarket data
  • safety information
  • safety data

  • critical path
  • iom report
  • event reporting
  • biologic products
  • taking steps

  • adverse event
  • preand postmarket
  • postmarket decision
  • expanding safety
  • pharmaceutical drug

  • current drug
  • identify safety
  • drug user
  • stores safety
  • safety evaluation

  • submitted safety
  • postmarket findings
  • safety throughout
  • drug evaluation
  • safety database

  • safety surveillance
  • postmarket electronic
  • safety regulation
  • drug vioxx
  • improve safety


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