Saturday, June 2, 2012

FDA Working with Patients to Explore Benefit/Risk: Opportunities & Challenges

 


FDA Holds First-Ever Patient Network Meeting


Peper Long, associate director of External Relations for the Center for Devices and Radiological Health ("CDRH"), said that the FDA relies on patients to report adverse events to the agency in order to monitor the safety of medical devices and identify problems. "We want and need more information in those reports," Long said. She explained that a central strategy for the FDA this year is to create a national post- market strategy to better monitor patient feedback. Patient advocacy attendees also weighed in on the issue and suggested that patients would be more likely to provide feedback and report adverse events if a more effective system is implemented

Friday, May 18, 2012 at the FDA White Oak Campus, in Silver Spring, MD.

U.S. Food and Drug Administration Inaugural Patient Network Annual Meeting, hosted by FDA's Office of Special Health Issues (OSHI) in collaboration with the Center for Drug Evaluation and Research (CDER), the Center for Biologics Research and Evaluation (CBER), and the Center for Devices and Radiological Health (CDRH).

This meeting was held to allow FDA to gain a greater understanding of how patients define and perceive benefits and risks related to medical products. The FDA Patient Network hosted this one-day meeting to:

  • review the drug and medical device regulatory processes;
  • discuss where patient input is practical and most valuable; and,
  • explore practical approaches to collecting meaningful patient input.

The meeting included a series of presentations, exercises, and panel discussions to facilitate a conversation with the patient community about these important topics. FDA asked patients and other interested parties to consider specific questions, posed in a 4/19/2012 Federal Register Notice1, designed to frame discussion at the meeting.

Working with Patients to Explore Benefit/Risk: Opportunities & Challenges

Video Recording of the May 18, 2012 event:


  • Keynote Address Stephen Spielberg, M.D., Ph.D., Deputy Commissioner for Medical Products and Tobacco
  • Drug Development: Laws, Regulations, Statutory & Regulatory Limitations Janet Woodcock, M.D., Director, CDER


  • Drugs and Biologics Development 101 Robert Yetter, Ph.D., Associate Director for Review Management, CBER
  • Devices 101 Peper Long, Associate Director, External Relations, CDRH
  • Drugs, Biologics and Devices Question and Answer
    Richard Klein, Director, Patient Liaison Program, OSHI (moderator)


  • Benefit-Risk Framework Patrick Frey, Director, Office of Planning and Analysis, CDER
  • Patient-Focused Drug Development Theresa Mullin, Ph.D., Director, Office of Planning and Informatics, CDER
  • Making Benefit-Risk Determinations Peper Long, Associate Director, External Relations, CDRH
  • Patient Risk Tolerance Survey for Obesity Devices Martin Ho, M.S., Division of Biostatistics, Office of Surveillance and Biometrics, CDRH


  • Patient Risk Tolerance Survey for Obesity Devices Martin Ho, M.S., Division of Biostatistics, Office of Surveillance and Biometrics, CDRH (continued)
  • Discussion of Federal Register Notice Questions
  • Patient Perspectives Panel & Audience Discussion James Valentine, M.H.S., Project Manager, FDA Patient Network, OSHI (moderator)
  • FDA Reaction Panel James Valentine, M.H.S., Project Manager, FDA Patient Network, OSHI (moderator)
  • Closing Remarks Richard Klein, Director, Patient Liaison Program, OSHI



Original Federal Register Notice of Meeting6, with framing questions



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