As Zika funding remains an uphill battle on Capitol Hill, ABC remains steadfast in our advocacy efforts. We continue to work toward an opportunity for a line item funding Zika testing at blood centers, an option that may be the best for long-term sustainability of appropriation.
In hopes for funding within an omnibus bill, ABC has and continues to conduct a series of high-level meetings with House and Senate committees and members of Congress along these talking points:
- Congress and the Administration should recognize the need for full cost recovery under IND associated with universal ID-NAT testing for Zika.
- Congress and the Administration should ensure that implementation of the most recent Food and Drug Administration (FDA) guidance is imposed fairly and consistently among all partners within the blood community; and
- The Administration should examine its risk-based decision making process as it applies to future guidance to ensure the most appropriate standards related to the safety of the nation’s blood supply.
Despite significant challenges and obstacles, 84 percent of ABC members report that they will be able to meet all timelines in the FDA guidance for universal Zika testing, according to this month’s ABC Zika Implementation Survey. The diligence of ABC members investing in additional training, staff, and instrumentation for laboratories-all without certainty on how these additional costs will be recovered-is a testament to their dedication toward public health and compliance.
ABC has asked for flexibility in implementation from the FDA in regards to universal Zika testing for all blood donations. The FDA has assured us that they will work individually with our members who inform the agency of an inability to comply fully with the donor testing requirements. The FDA remains committed to ID-NAT and has assured ABC that they will not provide special dispensation for any particular collector that they would not for another.
ABC centers that are unable to comply with the August 26th guidance requirements should contact FDA through their Consumer Safety Officer (CSO) to discuss their path to implementation. Your single source for Zika information can be found on our member site. ABC’s expert staff is available for consultation at any time.
Christine Zambricki, DNAP, CRNA, FAAN; Chief Executive Officer