FDA Proposes Guidelines to Mandatory One-Year Blood Ban
The U.S. Food and Drug Administration (FDA) Tuesday announced proposed guidelines for blood donations that change the current lifetime ban for men who have sex with men (MSM) to a one year ban.
“No transmissions of HIV, hepatitis B virus, or hepatitis C virus have been documented through U.S.-licensed plasma derived products in the past two decades,” the FDA reported.
The FDA also explained, “We recommend that donors be provided donor education material before each donation explaining the risk of HIV transmission by blood and blood products, certain behaviors associated with the risk of HIV infection, and the signs and symptoms associated with HIV infection, so that donors can self-defer,” FDA says. “The donor education material should be presented to donors in a manner they will understand, which may include oral, written, or multimedia formats. The donor education material should instruct the donor not to donate when a risk factor for HIV infection or signs or symptoms of HIV infection are present.”
In addition, the proposed guidance addresses the application of the MSM policy to transgender people, stating that transgender individuals should be allowed to self-identify and self-report their gender, but that in instances where a change in gender is asserted, the collection center may exercise its “discretion” as to whether the person may donate.
The proposed guidelines arrive after the recommendations were announced in December, following increasing calls from LGBT advocates and the medical establishment, including the American Red Cross, the American Association of Blood Banks, America’s Blood Centers, and, most recently, the American Medical Association, to end the discriminatory and unnecessary ban. Today’s announcement officially starts the 30-day comment period on the proposed guidance.
White House Press Secretary Josh Earnest was questioned by the Washington Blade following the announcement. “It’s my understanding, based on what I’ve heard about this, the FDA has not rendered a final judgment on this, so this is the subject of ongoing consideration both by scientists, but also by the public health professionals at the FDA that have a responsibility for ensuring that the American people and their blood supply is fine,” Earnest said. “Obviously, we’re going to be guided by the science when it comes to this.”
Asked by the Blade why Obama’s stated opposition to anti-LGBT discrimination wouldn’t naturally apply to blood donations, Earnest maintained the president has “a very strong record” on LGBT rights, but said other factors are a consideration.
“He also feels strongly about making sure that we have an effective system that manages the reserve blood supply of the country, and we’re mindful of that, and that’s why we have some of the best scientists in the world at the FDA that are looking at this issue and making sure that we can reach a policy that is in the best interest of the country,” Earnest said.
Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Patty Murray (D-WA) released said, “The guidance released today was a step in the right direction, and I am pleased the FDA is moving forward to revise the lifetime ban on blood donations. However, I am disappointed that this guidance does not go far enough and continues discriminatory policies against many healthy gay and bisexual men. Healthy Americans, regardless of their sexual orientation, should have the opportunity to donate blood and help in the effort to save lives. I look forward to working with the FDA to build on these steps to remove discriminatory policies while keeping our blood supply safe.”
Scott Schoettes, Lambda Legal Senior Attorney and Director of the HIV Project, said: “Like the proposed change from a lifetime ban to a one-year ban for gay and bisexual men, the guidance announced today with respect to transgender people does not go far enough. An evidence-based policy would focus exclusively on the risk activities of the donor, and not on the identity of the donor or the identity of the person with whom the donor is engaging in those activities. Risk behaviors do not have a sexual orientation or gender identity.” Adding, “Deferrals should be based entirely on the conduct of the potential donor, rather than the person’s identity with regards to sexual orientation, gender identity or perceived risk factors based on the person’s identity. Within 45 days of exposure, currently required blood donation testing detects all known serious blood-borne pathogens, including HIV. Therefore, deferring anyone longer than two months is not necessary and does not noticeably enhance the safety of the blood supply.”
Schoettes further stated, “We are glad that the proposed new guidelines allow a subset of gay and bisexual men who have abstained from sex for a year to donate, but the proposed policy does not recognize the major advances in assessment of the level of risk from different activities or the significant strides made in detecting HIV and other blood-borne pathogens. Furthermore, while we are pleased transgender people will be able to affirm their gender identity in the donation process, the discretion provided to blood collection centers with respect to donors who identify as transgender exacerbates the uncertainty of the current policy and opens the door to further discrimination. HIV is transmitted only through activities involving risk, and the FDA should base its donation policies entirely on engaging in those activities, not on the identities of the people engaging in them. The solution we propose really is quite simple and straight-forward, and we are hopeful that the FDA will recognize this and continue moving us toward such an individualized risk-based policy.”
“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,” said the Human Rights Campaign top policy official, David Stacy. “This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply.”
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