FDA is responsible for ensuring the safety of the Nation's blood supply. While a blood supply with zero risk of transmitting infectious disease may not be possible, there are several measures taken by FDA to protect and enhance the safety of blood products.
The blood safety system established by FDA is dependent upon:
accurate and complete educational material for donors so that they can assess their risk;
sensitive communication of the donor screening questions;
donor understanding and honesty;
quality controlled infectious marker testing procedures;
appropriate handling and distribution of blood and blood products for patient use.
Because of the improvements in donor screening procedures and the use of a variety of new tests in the last few years, the blood supply is safer from infectious diseases than it has been at any other time.
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.
To View Public Meetings on Blood Donor Deferral (1998-2014)
Related Guidance Documents
- Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
- Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products - Guidance for Industry