FDA suggests individual risk assessments for blood donations to secure US blood supply
pharmafile | January 30, 2023 | News story | Medical Communications |
The FDA has announced that it is suggesting a change from the time-based deferrals for blood donation to an individual risk assessment system. The new system will assess blood donation eligibility using gender-inclusive, individual risk-based questions which should reduce the risk of transfusion-transmitted HIV. This system is similar to the systems used in the UK and Canada.
The FDA have based this proposal on data from other countries, as well as from its surveillance of the US blood supply. It has decided that the implementation of the individual risk-based questions will not impact the safety or availability of blood.
The new guidance includes: the removal of time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM; the revision of the current donor history questionnaire to ask all donors about new or multiple sexual partners in the last three months; prospective donors who report having new or multiple sexual partners in the last three months would be asked about a history of anal sex, those who report having anal sex within the last three months would be deferred from donation; any donors who do not report having new or multiple sexual partners or having had anal sex in the last three months should be eligible to donate as long as all other eligibility criteria are met.
Peter Marks, MD PhD, director of the FDA’s Center for Biologics Evaluation and Research, stated: “Our approach to this work has always been, and will continue to be, based on the best available science and data. Over the years, this data-driven process has enabled us to revise our policies thereby increasing those eligible to donate blood while maintaining appropriate safeguards to protect recipients. We will continue to follow the best available scientific evidence to maintain an adequate supply of blood and minimise the risk of transmitting infectious diseases and are committed to finalising this draft guidance as quickly as possible.”
Betsy Goodfellow
