America's Blood Centers Chief Medical Officer Louis Katz, MD, worked with the Food and Drug Administration (FDA), other industry leaders, and member blood centers in efforts to assess and manage the effect of emerging infectious diseases including Ebola and Chikungunya viruses. These efforts led FDA-authorized studies for the use of convalescent plasma to treat Ebola patients and pathogen reduction technology to prevent the spread of the Chikungunya virus. This work was complemented by two major donor surveys assessing the impact on donor availability of a potential 14 or 28 day deferrals for travel outside the US and Canada. Scientific, Medical, and Technical staff input has helped move forward a decade-long project to rationalize the FDA's approach to managing plasma for further manufacture derived from volunteer donors. These regulatory efforts were accompanied by legislative advocacy (described below), and FDA is now expected to publish regulations on this matter via a Guidance during calendar 2015.
America's Blood Centers also challenged the regulators in the areas of laboratory developed tests and medical data device systems, submitting extensive comments to Draft Guidances and proposed rules.
Last year, America's Blood Centers continued making strides on its Advocacy Agenda, which focuses on four main goals: achieve plasma flexibility; address the "value of blood" issue with a report demonstrating the gap in the blood economy between what is necessary for the adoption of innovation and a plan for reimbursement reform; improve the timeliness and transparency of the FDA; and reduce the administrative burden of quality control testing. America's Blood Centers' staff and members have employed a multi-modal approach including legislative, regulatory, grassroots, and grass tops research and communications to achieve these goals.
America's Blood Centers continued its efforts to encourage the FDA to create more flexible regulations surrounding the manufacturing of apheresis plasma into life-saving clotting factors used to treat patients with bleeding disorders. In August 2014, letters supporting regulatory change were sent by an America's Blood Centers-led coalition of organizational members of the blood community, and America's Blood Centers met with FDA regulators to express our concerns and discuss our proposals.
In support of these efforts, America's Blood Centers hosted a Congressional fundraiser to support Rep. Sam Farr (D-CA), a member of the House Appropriations Subcommittee and a strong voice on the issue of plasma regulation flexibility, during the Annual Meeting in March 2015. That same week, America's Blood Centers' members were seen on the Hill, participating in a grassroots effort to education members of Congress about the association's advocacy goals.
In January 2015, FDA's Center for Biologics Evaluation included in its listing of guidance documents to be published this year a draft guidance that would increase the flexibility of plasma regulations. As a result of advocacy efforts both on the Hill and through grassroots methods, America's Blood Centers was successful in securing language in the House Appropriations Subcommittee's annual report asking the FDA to move this draft guidance forward.
To advance the initiative on the value of blood, America's Blood Centers conducted interviews with healthcare policy think tanks resulting in five proposals for the project. Staff next addressed funding for the project, meeting with leaders at the National Institutes of Health and the office of the Assistant Secretary of Health and Human Services to solicit funding. Staff also worked with healthcare organizations and the Senate Committee on Health, Education, Labor & Pensions to improve the timeliness and transparency of FDA.
America's Blood Centers and our member blood centers celebrated
World Blood Donor Day (June 14) with the 6th Annual
Nexcare give promotion. Through this partnership, participating
blood centers received a supply of "creating a culture of giving"
The 2015 limited-edition bandage collection features eight globally-inspired, vibrant designs, patterns and textiles from various cultures and locations from around the world. Additionally, extensive media outreach was done on behalf of both America's Blood Centers and its member blood centers to garner media attention in print, online, and broadcast news outlets both at the local and national level.
America's Blood Centers distributed four press releases during the year. Staff and spokespersons conducted numerous interviews, while assisting the following print, online, broadcast media outlets and government organizations:
The Migrant Students Foundation, in partnership with America's Blood Centers and its members, hosted the 7th annual National Cesar E. Chavez Blood Drive Challenge in the spring of 2014. This evergrowing nationwide campaign encourages students - especially of Hispanic/Latino descent - to promote health education, health and science careers, and saving lives.
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