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NHF Presents at FDA Blood Safety Workshop

June 1, 2010

On Thursday, May 13, 2010, NHF CEO Val Bias gave the presentation, "Qualitative Risk Assessment: Blood Safety and Availability," at an FDA workshop. The purpose of the workshop was to examine issues related to the conduct and use of risk assessments for blood and blood products.  Other presenters throughout the day included researchers from the FDA Center for Biologics Evaluation and Research, public health officials from the U.S. and Canada, epidemiologists and representatives from the blood bank community.

The day's discussion centered on the question of how to improve the risk assessment process and the communication of risk.  Risk assessments can be done by a variety of organizations, such as businesses, manufacturers and government agencies, to evaluate the potential harm posed by a policy change or new product, and to weigh it against the potential benefit.  Bias shared the perspective of the patient community, offering his opinion on how patients and patient organizations can be more involved in the risk assessment process.  Throughout his presentation and the ensuing panel discussion, he advocated for a more prominent role for consumers.  Because patients bear the ultimate risk, Bias explained, they should be involved early in the process and help frame the questions of the risk assessment.  Moreover, patient organizations, such as NHF, have the tools and capacity to effectively communicate risks to the public, he stressed.

The workshop brought together many stakeholders in the blood and blood products community, and a wide range of views were expressed.  NHF's participation brought a human element to what is otherwise a highly scientific and technical process. It reminded participants that risk assessments have a personal impact on the patients who rely on blood and blood products.