The U.S. Food and Drug Administration’s current policy of prohibiting men who have sex with men from donating blood is no longer supported by medical evidence and should be replaced with a less restrictive donor policy, according to a federal advisory panel of experts in blood-related diseases.
The U.S. Advisory Committee on Blood and Tissue Safety and Availability voted 16 to 2 on Thursday to recommend that the FDA discontinue its 31-year-old blanket policy of permanently banning blood donations by men who have sex with men, or MSM, and instead require a one-year period of same-sex sexual abstinence for MSM prior to their donating blood.
The vote took place during a public meeting at the Double Tree by Hilton Hotel in the Pentagon City section of Arlington, Va. At least five representatives of LGBT organizations, including an official with the Gay and Lesbian Medical Association, spoke at the meeting before the vote, urging the panel to call for fully lifting the ban on MSM donors.
The committee’s recommendation to replace the ban with a one-year period of sexual abstinence drew mixed reactions from the LGBT advocates.
“This recommendation – although nominally better than the existing policy – falls far short because it continues to stigmatize gay and bisexual men, preventing them from donating life-saving blood based solely on their sexual orientation,” said David Stacy, director of government affairs for the Human Rights Campaign.
“The current policy, adopted in the earliest days of the HIV/AIDS epidemic, and the new recommendation are both simply wrong and can no longer be justified in light of scientific research and updated blood screening technology,” Stacy said in a statement.
Ryan James Yezak, founder of the National Gay Blood Drive, which arranges for straight allies to donate blood in place of gay and bisexual men who are banned from doing so, called the advisory committee’s action “a huge step in the right direction.”
“But there is more work to be done,” said Yezak in a statement. “We still have to eliminate sexual orientation from the blood donation process.”
Gay activists Jay Franzone, who serves as communications director for the National Gay Blood Drive, and Caleb Michael Laieski, a 19-year-old LGBT youth advocate who has filed a lawsuit seeking to force the FDA to end its ban on MSM blood donors, each called the committee’s recommendation an important first step in ending the ban.
“Today progress was certainly made,” Laieski said.
“It was a huge sense of accomplishment when they voted,” said Franzone, who joined Yezak in calling for a full lifting of the ban on MSM donors.
Diane Gianelli, a spokesperson for the U.S. Department of Health and Human Services, which oversees the FDA, said the action by the advisory committee is just the first in a multi-step process that must be completed before a final decision is made on whether to change the existing FDA policy.
She said the committee’s recommendations will be sent to another federal advisory panel — the FDA’s Blood Products Advisory Committee — in early December.
FDA spokesperson Jennifer Rodriguez said that committee will make its own recommendations on the MSM donor policy to the FDA. She said the FDA in turn will weigh a number of factors, including “an updated risk assessment model for the impact of a potential change to the MSM deferral on HIV blood safety” before deciding whether to make changes in the existing donor policy.
“The FDA will consider both committees’ recommendations and input from HHS and our sister agencies as we review the MSM deferral policy,” she said. “If a policy change is decided upon, FDA would issue a draft guidance document for comment that would be announced in the Federal Register…After receiving comments from the public comment period, FDA would issue a final guidance document,” Rodriguez said.
In their testimony prior to the committee’s vote, five LGBT rights advocates urged the panel to lift the ban on MSM blood donors on grounds that it’s medically unnecessary and stigmatizes gay and bisexual men. They also noted that the ban prevents blood donor organizations such as the Red Cross from obtaining life-saving blood supplies needed by thousands of patients.
Among those testifying were Yezak, Franzone and Laieski. Also testifying were Jesse Joad, physician and president-elect of the Gay and Lesbian Medical Association; and former congressional staffer and transgender activist Diego Sanchez, who delivered testimony prepared by Jody Huckaby, executive director of PFLAG, the LGBT parents and families group.
The existing FDA policy places a permanent “deferral” or ban on donating blood by any man who has had even one sexual contact with another man since 1977.
On its website, the FDA says it continues to believe the policy is justified because “MSM are, as a group, at increased risk for HIV, hepatitis B and certain other infections that can be transmitted by transfusion.”
The website statement adds, “Men who have had sex with other men represent approximately 2 percent of the U.S. population, yet are the population most severely affected by HIV.” Although all donated blood undergoes testing for HIV and other diseases, a small percentage of infected blood slips through the testing process, according to the FDA statement, and removing from the donor pool people with a higher risk of being infected with HIV and other diseases reduce the chances that infected blood that’s undetected will be given to patients.
In its action on Thursday, the advisory committee adopted a resolution saying several recent scientific studies “provide the [committee] with sufficient information to support a change from the current MSM deferral policy…to an alternative policy that would permit blood donations by some MSM.”
A separate resolution, also adopted by a vote of 16 to 2, calls for the one-year sexual abstinence period for MSM as a condition for donating blood.
Like all potential blood donors, men who have sex with men would be required to complete a detailed questionnaire and screening interview asking about their health and medical history along with other questions presented to all prospective donors.
“This past summer, 1,500 gay and bisexual men came out and showed their willingness to contribute to the nation’s blood supply by bringing 1,500 eligible allies to donate in their place,” Yezak said in his testimony before the advisory committee.
“A total of 3,000 individuals participated in the event and together we helped save up to 4,500 lives,” he said. “We would have double that amount if it weren’t for the MSM lifetime deferral,” he said.