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Keeping Blood Safe: An Interview with the New Assistant Secretary for Health

"At a time when our nation faces many challenges, it gives me confidence that these fine individuals have agreed to give their talents to serving the American people,” President Obama said after announcing some key nominations to his cabinet last March. “They will be a valuable addition to my administration, and I look forward to working with them. …” As with previous presidents, Obama had the opportunity to nominate individuals who would help him achieve his policy goals. One of those people was Howard Koh, MD, MPH, who was nominated and confirmed as the 14th assistant secretary for health for the U.S. Department of Health and Human Services.

A physician with certifications in several specialties including hematology, Koh is no stranger to addressing challenges. Before his nomination, Koh served in several leadership roles at Harvard University, including as director of the Harvard School of Public Health Center for Public Health Preparedness, which promotes education about bioterrorism, pandemic influenza and other health threats. He also was the principal investigator of multiple research grants at Harvard related to cancer disparities affecting underserved and minority populations, tobacco control and emergency preparedness. Before his Harvard tenure, Koh was the commissioner of public health for Massachusetts from 1997 to 2003.

In his new role at HHS, Koh oversees all federal blood safety policies, making him a touchstone of the administration’s vision on policies affecting the transfusion medicine and cellular therapy communities. He recently took some time to answer a few questions from AABB News about his and HHS’ priorities — including improving preventive medicine and forging stronger relationships with industry.

Please explain your role in overseeing blood and transfusion medicine-related issues at HHS.
First of all, it is great to return to public service. Being part of public health now at the federal level is a tremendous honor. The sense of mission in service is inspiring and gratifying, and I am particularly delighted to be reunited with colleagues from AABB to work closely on areas of interest for the country.

As the ASH [assistant secretary for health], I have the privilege of serving as the blood safety officer for the country to ensure the coordination of blood safety policies and the availability of blood products. More specifically, on behalf of [Secretary Kathleen Sebelius], I coordinate policies for the department, particularly with respect to integrating activities of the public health agencies. They include the National Institutes of Health, Centers for Disease Control and Prevention, the Food and Drug Administration, and Heath Resources and Services Administration, among others. We also work very closely with the Centers for Medicare and Medicaid Services. So my coordination responsibilities are broad but consistent with our office mission statement: “Mobilizing leadership in science and prevention for a healthier nation.” That statement certainly applies to blood and transfusion medicine and related issues.

Do you see a role for the HHS Advisory Committee on Blood Safety and Availability in the field of cellular therapies? If so, what role do you see?
The Advisory Committee on Blood Safety and Availability reports its recommendations to both me and [Secretary Sebelius], and it provides a strong foundation for transfusion and transplantation safety. With respect to cellular therapy, this is an area in which regulatory oversight is very complex and involves bone marrow, peripheral stem cells and cord cells. So, my role in the cellular therapy arena, along with Dr. Jerry Holmberg — our senior advisor for blood policy and the executive secretary for the Advisory Committee on Blood Safety and Availability — is to coordinate and integrate departmental activities, particularly with FDA, HRSA and other agencies.

What are your priorities for blood safety- and availability-related policies at HHS?
As the ASH, one of my highest strategic priorities has to do with creating better systems of prevention. As a clinician who has cared for patients for more than 30 years, I have seen too many patients enduring preventable suffering and dying preventable deaths. So I carry a special passion for prevention, which is so relevant to blood safety. There are many opportunities to reduce adverse outcomes, particularly with respect to biovigilance. There is much good progress to report. Over the last three years an HHS group has worked together to create a white paper titled “Biovigilance in the U.S.: Efforts to Bridge a Culture Gap in Patient Safety and Donor Health.” This white paper represents a comprehensive, integrated effort by all of HHS with respect to patient safety issues, promoting awareness and advancing public health relevant to blood transfusion and transplantation of organs and tissues. That document is now posted online at www.hhs.gov/bloodsafety. It represents the culmination of a tremendous amount of work, and we are very proud of that effort. Every public health agency in HHS signed off on it, the advisory committee was instrumental in helping to create and finalize the product, and now we are moving on to develop an action plan and an implementation plan
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