FDA Seeks Public Comment on Blood Donor Deferral Policy

Content From: Steve Morin, Cmdr. Steve Morin, R.N., B.S.N., Director, FDA Patient Network, Office of Health and Constituent Affairs, FDAPublished: August 01, 20162 min read


Editor's Note: Here is a guest blog from the Food and Drug Administration (FDA).

On July 26, 2016, the Food and Drug Administration (FDA) issued a notice in the Federal Register titled “Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.”

FDA issued a Final Guidance in December 2015, that changed the decades-old indefinite blood donor deferral policy regarding men who have had sex with men (MSM) to a one-year deferral since the last sexual contact with another man.

This change better aligns the deferral period with that of other men and women engaging in behaviors that place them at increased risk for HIV infection (e.g., those who had a recent blood transfusion or accidental exposure to the blood of another individual, or had other potential exposure to a potentially bloodborne disease).

When this policy was updated in 2015, the FDA promised that they will continue to reconsider the donor deferral policies as new data become available.

The FDA is making good on their promise and is seeking science-based comments to the newly opened docket on:

  • The feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessment.
  • The design of potential studies to evaluate the feasibility or effectiveness of such alternative deferral policy options.
  • Other science-based comments that will help shape future decisions.

The public docket will be open for comments until November 25, 2016.

FDA regularly interacts with patient groups, academicians, and industry scientists to remain current with outstanding issues of concern and technological advances. The FDA’s priority is to ensure the high level of safety of our blood supply, which is critical to patients who need these life-saving products. If you would like to speak with us, please contact us at patientnetwork@fda.hhs.gov.