FDA Proposes Policy Change for Blood Donation

A longstanding policy of the US Food and Drug Administration (FDA) could be coming to an end as Commissioner Margaret A. Hamburg released a statement with proposed changes to the blood donor deferral for homosexual men.

Hamburg said the proposed changes for men who have sex with other men can ultimately be a change in the way the FDA works to “regulate the blood supply and help to ensure its continued safety for the patients who receive these life-saving products.”

Hamburg said the FDA has been working over the “past several years” to find the latest information relevant to the policy and whether it could be changed to open the donor pool. According to an article in The New York Times the current blood donor policy was established in 1983 when the AIDS epidemic was in its infancy and very little was known about the disease.

“Following this review, and taking into account the recommendations of advisory committees to the US Department of Health and Human Services (HHS) and the FDA, the agency will take the necessary steps to recommend a change to the blood donor deferral period for men who have sex with men from indefinite deferral to one year since the last sexual contact,” Hamburg said.

Recommendations to make the changes have come in the past from not only independent organizations but also the HHS Advisory Committee on Blood and Tissue Safety and Availability. The statement said the proposed changes will “better align the deferral period with that of other men and women at increased risk for HIV infection.”

While these changes are a big shift for the FDA policy, Hamburg said more changes could be coming in the future. “In collaboration with the NIH’s National heart Lung and Blood Institute (NHLBI), the FDA has already taken steps to implement a national blood surveillance system that will help the agency monitor the effect of a policy change and further help to ensure the continued safety of the blood supply.”

More formalized guidelines are expected to be introduced in 2015 and will be open to public comment at that time. “We encourage all stakeholders to take this opportunity to provide any information the agency should consider, and look forward to receiving and reviewing these comments,” Hamburg added. Approval of the new policy would make it similar to the guidelines established in the United Kingdom according to the Times.