- A new FDA proposal could relax restrictions on blood donations from men who have sex with men.
- The proposal will now undergo 60 days of public comment before new recommendations and guidelines would go into place.
- By relaxing the rules, the FDA could help combat shortages of blood.
The Food and Drug Administration (FDA) has
“This is a very good direction to take and it’s long overdue,” said Hannah Newman, director of infection prevention, Department of Epidemiology at Northwell Health’s Manhattan Campus. “We’ve had so many blood shortages. As someone who works in the field of infectious diseases, I think this is the right direction.”
The new FDA proposal suggests a change from time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV.
Donor deferral, according to the Association for the Advancement of Blood & Biotherapies, means that an individual is not eligible to donate based on current requirements.
It requires a waiting period to protect the health and safety of the donor and the patient who receives the donated blood.
For decades men who have sex with men were barred from ever donating blood over the perceived risk of transmitting HIV, but the FDA has changed these rules in recent years.
Under the current policy, men who have sex with men can not donate blood unless they abstained from sex with men for three months.
“The restrictions were put in place several decades ago because of the concern about the transmission of HIV, which was the infection that was particularly focused on men who have sex with men,” said Dr. William Schaffner, professor of preventive medicine and health policy, Division of Infectious Diseases at Vanderbilt University School of Medicine. “Back in those days, we didn’t have the confidence in the tests that we use on every blood donation. The FDA is moving in concert with the science and the general public health confidence in the system for blood donation.”
“There has been a lot of criticism of the preexisting rules,” said Newman. “We have more data and science, so we want our policies and procedures around this to reflect science and not stigma. Risk factors for HIV can exist regardless of gender and sexual orientation and the FDA is taking that into account.”
Under the FDA’s new proposal, anyone who wants to donate blood, regardless of gender or sexual orientation, will be subject to the same questions. According to the FDA, under the new proposed guidance:
- The time-based deferrals for men who have sex with men and women who have sex with men who have sex with men would be eliminated.
- The current donor history questionnaire would be revised to ask all prospective donors about new or multiple sexual partners in the past three months.
- Prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, would then be asked about a history of anal sex in the past three months.
- All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months would be deferred from donation.
- A prospective donor who does not report having new or multiple sexual partners, and anal sex in the past three months, may be eligible to donate, provided all other eligibility criteria are met.
Once blood has been donated, the blood will then undergo testing.
“The system for blood donation is a double-barrel safety system,” said Schaffner. “The first thing that happens is you’re obliged to answer questions. If you’ve been engaged in what is still considered risky behavior, you have to defer your donation. Then when you donate, every unit that is donated is tested for HIV infection along with a long list of infections. We have sufficient confidence in these tests that if we do the double-barreled safety precautions that the risk to recipients is going to be no larger in the future than it is at the present time.”
Countries like the U.K. and Canada operate under a similar system to what the FDA is proposing, and in monitoring the results in those countries it helps to add to the confidence that this is the direction in which we ought to be moving.
The proposal will now undergo 60 days of public comment before new recommendations and guidelines would go into place.
“The big change,” added Newman,” is the elimination of time-based deferrals for men who have sex with men and women who have sex with men who have sex with men. It would increase the opportunity for people who otherwise have not been eligible to donate.”
What is not changing, however, is the restrictions for other risk factors, like non-prescription IV drug use and those who have paid for sexual intercourse over a period of time.
“But this one change would open the door to look at an individual’s risk factor,” said Newman.
“There are two great advantages to doing this,” said Schaffner. “The first is it opens up more sources for the blood supply. We’re always out there asking for donations and now we have more potential donors. The other thing is that it reduces the stigma and sense of separateness of the men who have sex with men community. We can provide reassurance that they can be donors safely if everyone adheres to the two-phased safety precautions.”