FDA Reduces Gay Blood Donation Ban to 1 Year After Sex, Critics Say It's Still Discriminatory

alt

On May 12 the U.S. Food and Drug Administration (FDA) issued draft guidance stating that men who have sex with men should wait to donate blood until 12 months after their last sexual contact with another man. This is an improvement over the previous policy of lifetime deferral, but some advocates argue that the new regulations still discriminate against gay and bisexual men.

This policy recommendation follows an announcement by the Obama administration in December that it planned to change the deferral rules for men who have sex with men (MSM). The old policy -- stating that men who have had sex with men since 1977 could never donate blood -- was put in place 3 decades ago, during the early years of the epidemic, when less was known about HIV transmission and stigma against gay men and people with HIV was greater.

Donated blood in the U.S. is now tested using sensitive assays that can detect HIV and other pathogens soon after infection. The FDA estimates that the risk of contracting HIV via a blood transfusion is approximately 1 in 1.5 million. "No transmissions of HIV, hepatitis B virus, or hepatitis C virus have been documented through U.S.-licensed plasma derived products in the past 2 decades," according to the agency.

In considering revisions to the previous policy, the FDA reviewed scientific evidence, worked with other government agencies, and considered input from external advisors. Recent epidemiological data does not show that gay and bisexual men pose a safety risk to the blood supply.

For example, research from Australia shows that changing from indefinite deferral to a 1-year deferral for MSM in 2000 did not have an adverse effect on the safety of the blood supply. A safety review also led the UK to change its lifetime blood donation ban for MSM to a 1-year deferral in 2011.

The new policy "better aligns the deferral period for MSM with the 1-year deferral period for other men and women at increased risk for HIV infection, reflects current scientific evidence showing that an adverse effect on the safety of the blood supply is unlikely, and is likely to improve MSM adherence to the deferral period," according to an FDA announcement of the change.

The proposed policy continues to recommend indefinite deferral for anyone who has ever tested positive for HIV, sex workers and anyone else who has ever exchanged sex for money or drugs, and anyone who has ever engaged in non-prescription injection drug use.

In addition to MSM, the policy also recommends 1-year deferral for people who have received blood transfusions, sustained a needlestick injury, had syphilis or gonorrhea, or had sex with anyone in the indefinite categories within the past 12 months. Tattoos and body piercings are permitted if done by regulated entities with single-use equipment.

The policy does not adjust deferral recommendations based on the relative riskiness of specific types of sex or use of safer sex practices. It does not distinguish between anal, vaginal, and oral sex, nor does it mention condom use, pre-exposure prophylaxis (PrEP), or antiretroviral treatment as prevention.

The agency stated that it would monitor the outcome of the proposed change for MSM to assure that blood safety is maintained before considering any further policy changes.

The draft Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products is available online and is open for comments for 60 days. Comments may be submitted via www.regulations.gov.

Policy Unfair, Some Say

Medical organizations including the American Medical Association and the Red Cross agreed that the original indefinite deferral policy for MSM was not supported by scientific evidence and favor the change to a 1-year deferral.

The American Medical Association "commends the [FDA] for taking a step in the right direction to end the lifetime ban that prohibits men who have had sex with men from ever donating blood," AMA president Robert Wah said in a statement. "The AMA's policy supports using scientifically based deferral periods that are consistently and fairly applied to donors based on their risk level."

"Replacing the lifetime ban on blood donation by men who have sex with men with a 1-year deferral, and recommending self-reporting as well as case-by-case discretion on donations, by transgender individuals, the new draft guidelines acknowledge that risks are tied to behaviors, rather than individuals," HIV Medicine Association chair Adaora Adimora stated. "We recommend that blood donor screening procedures be revised to ask all potential donors to exclude themselves if within the previous 6 months they have tested positive for HIV, engaged in unprotected sex with a partner with HIV or unknown HIV status, or used a syringe not prescribed by a physician. We recommend additional studies to develop blood donation deferral criteria to protect the blood supply while reducing discriminatory exclusion of HIV-negative individuals."

However, some LGBT advocates have criticized the new policy -- both this week and after the Obama announcement last December -- arguing that the 1-year deferral policy unfairly singles out gay and bi men and that policies should be based on behavior, not sexual orientation or identity.

"While the new policy is a step in the right direction toward an ideal policy that reflects the best scientific research, it still falls far short of a fully acceptable solution because it continues to stigmatize gay and bisexual men," Human Rights Campaign government affairs director David Stacy stated in a press release. "This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply. It simply cannot be justified in light of current scientific research and updated blood screening technology."

"As the ACLU made clear late last year, this inadequate proposal must be seen as part of an ongoing process and not an end point," the American Civil Liberties Union stated. "Deferral decisions should be based on activities presenting an elevated risk, not on the identity of a person or that person’s partner. The reality for the vast majority of gay and bisexual men is that this policy continues to stigmatize their intimate relationships and will indefinitely bar them from donating. In addition, this proposal leaves open the possibility that transgender individuals will continue to be needlessly barred from being able to donate."

Background information about the MSM donor deferral policy and links to records from public meetings on the issue between 1998 and 2014 are available on the FDA Blood Donor Deferral website.

5/19/15

Sources

U.S. Food and Drug Administration. Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products. Draft Guidance for Industry. May 12, 2015.

American Medical Association. AMA Commends U.S. Food and Drug Administration for Efforts to Reverse Lifetime Blood Donation Ban. Statement. May 12, 2015.

HIV Medical Association. HIVMA supports release of revised blood donor draft guidelines, calls for further evidence-based updates. Statement. May 12, 2015.

Human Rights Campaign. FDA Blood Donation Ban Change Still Unacceptable. Press release. May 12, 2015.

ACLU. DHS Publishes Draft Guidance on Blood Ban for Gay and Bisexual Men. Statement. May 12, 2015.