The Food and Drug Administration (FDA) announced on Tuesday that it would recommend a change to the indefinite blood donor deferral period for men who have sex with men to one year since the last sexual contact.
The FDA intends to issue draft guidance recommending this proposed change in policy in early 2015, which will also include an opportunity for public comment.
Under the current policy, men who have had sex with other men since 1977 are permanently barred from donating blood, including men who are HIV-negative, practice safe sex or are in a monogamous relationship. The FDA implemented the ban at the dawn of the HIV epidemic in 1983 to prevent inadvertent transmission of HIV through blood transfusions.
The change comes after several years of considering scientific evidence relevant to the deferral policy, including results of recently completed scientific studies and epidemiologic data, as well as recommendations of advisory committees to the Department of Health and Human Services (HHS).
The recommended change, the FDA said, is consistent with the recommendation of an independent expert advisory panel, the HHS Advisory Committee on Blood and Tissue Safety and Availability, and will better align the deferral period with that of other men and women at increased risk for HIV infection. In collaboration with the National Institutes of Health’s National Heart Lung and Blood Institute (NHLBI), the FDA has also taken steps to implement a national blood surveillance system that will aim to help the agency monitor the effect of a policy change and further help to ensure the continued safety of the blood supply.
An estimated 45 percent of men in the U.S., about 54 million, are eligible to donate blood and almost 9 percent of those eligible actually donate. Annually, there are 15.7 million donations of blood by 9.2 million donors (about 1.7 donations per donor). Half of the men who are currently not able to donate because of the indefinite deferral will be able to donate under the proposed new policy, according to FDA Deputy Director Dr. Peter Marks.
The American Red Cross called the FDA’s decision “consistent” with its position that the “current lifetime deferral is unwarranted.”
The American Red Cross accounts for about 40 percent of the nation’s blood supply. The organization collected nearly 5.7 million units from 3.3 million donors during Fiscal Year 2013 through its 36 regional blood service centers.
Via a statement, Chief Medical Officer Dr. Richard Benjamin said that this process is just beginning and that the lifetime blood donation deferral is still in place. “The process to change it will take time,” he said, and they will review draft guidance that will come out in early 2015.
It’s unclear how many new blood donors the policy change might bring Red Cross, which declined to comment beyond the prepared statement.
The Red Cross reiterated that it “strongly supports the use of rational, scientifically-based deferral periods that are applied fairly and consistently among blood donors who engage in similar risk activities. We also support the advisory committee’s recommendations for sustainable monitoring of changes in blood safety following implementation of a new deferral policy.”
The statement was essentially echoed by the America’s Blood Centers. “It is a smaller number at a time of declining blood use, but this has never really been about a significant increase in the blood supply. It is about good science, medicine and fairness,” said Chief Medical Officer Dr. Louis Katz.
The Red Cross reports that the risk of HIV in a unit of donated blood is 1 in 1.5 million units although those that test positive usually number in the hundreds each year and are pulled out of the blood supply, Marks said in a conference call with reporters on Tuesday. Projected against the 15.7 million blood unit donations annually in the U.S., that might mean fewer than 11 units.
Analysis by The Williams Institute on Sexual Orientation and Gender Identity Law and Public Policy at UCLA School of Law suggests that lifting the ban could increase the total annual blood supply by 2 to 4 percent. The institute issued an update in September on the effects of lifting blood donation bans on men who have sex with men, examining the effect of three scenarios: lifting the ban completely, shifting to a one-year deferral (as was done in the United Kingdom), and shifting to a five-year deferral (as was done in Canada).
Under a one-year deferral, as proposed by the FDA, the institute estimates that an additional 2.16 million men would be eligible to donate blood and of those, an additional 185,800 men would likely donate 317,000 additional pints of blood annually. If the ban were completely lifted, more than 4.2 million additional men would be eligible, with 360,600 of those men likely donating 615,300 additional pints.
“Some may believe this is a step forward, but in reality, requiring celibacy for a year is a de facto lifetime ban,” according to Gay Men’s Health Crisis (GMHC). In a statement released this afternoon, the New York City-based organization described the new policy as offensive and harmful. “The FDA finally announced that gay and bisexual men may finally be allowed to donate blood – but only if they are celibate for one year, regardless of their risk for HIV. However, this new policy does not require heterosexual blood donors to be celibate for one year.”
GMHC said the FDA’s new policy will continue to “fan the flames of the outdated stereotype that HIV is only a ‘gay disease,’” adding that the American Medical Association, American Red Cross, America’s Blood Centers and Association of Blood Banks have all agreed that the lifetime band is “not only discriminatory but also is medically and scientifically unwarranted.”
While the FDA is right to revisit the lifetime ban, GMHC called on federal authorities to implement a “risk-based blood donation policy, regardless of sexual orientation or gender identity.” GMHC aims for a system that screens all donors, gay or straight, based on whether they engage in high-risk practices that could lead to HIV infection.
In response to the FDA’s decision to ease restrictions on its 31-year ban on gay blood donors, Scott Campbell, executive director of the Elton John AIDS Foundation in New York City, issued the following statement: “The Elton John AIDS Foundation is pleased that the FDA has taken a first step to lift the antiquated ban prohibiting gay men from donating blood. This announcement represents a long overdue shift in the public health field’s perception of gay men. While we urge the FDA to fully discard its ban, this step underscores what we have always believed: that all Americans, regardless of sexual orientation, should be allowed to help people in need. It’s part of ending stigma against LGBT Americans, and is simply the right thing to do.”