2018 ABC Advocacy Agenda
ABC supports the following objectives intended to maximize and promote the Value Framework:
Prioritize blood donation as a national imperative
- Establish partnerships that promote the need for blood donation, specifically among young donors and type-specific populations;
- Amend FDA regulations to maximize the gift of life. Currently, blood centers must discard an otherwise acceptable and safe blood donation if there is an error stemming from internal processes even if that error has no influence on the safety, purity or potency of the donation;
- Promote blood type utilization practices and standards that benefit patients and promote a robust blood supply.
Reform the federal agency structure in relation to blood products
- Create a direct reporting line between the HHS Office of the Assistant Secretary of Health and the Office of Blood Safety and Availability to promote research, planning, innovation and their requisite funding;
- Explore programs and reimbursement mechanisms to facilitate implementation of safety and technology measures when mandated by FDA or when market incentives otherwise do not exist.
Reduce unnecessary and burdensome regulation
- Finalize platelet bacterial contamination guidance in accordance with the recommendations of the Blood Products Advisory Committee in fulfillment of the CBER 2018 guidance agenda;
- Implement a rational, flexible approach to the regulation of plasma products. This includes harmonizing plasma freezing times with those required by manufacturers worldwide and advocating that the FDA give blood centers the ability to move plasma from transfusable to further manufacture as demanded by clinical need;
- Revise quality control options for platelets to assure safety and reduce burden to blood centers;
- Revise licensing regulations that prohibit distribution of products in interstate commerce that are acceptable for sale and use in the state of manufacture. These have undergone 100 percent quality control testing in process of licensure and this prohibition delays licensure and increases the costs of innovation;
- Evaluate the infectious disease testing burden from prespecified health economic thresholds. Reduce the burden of non-specificity (false positive tests) resulting in product and donor losses and cost;
- Eliminate the need to report post donation information (PDI) that do not result in a recall.