You Can Have Input on the FDA's Blood Donation Policy

The agency is taking comments online through Friday about a policy that would assess donors on risk factors for HIV rather than their sexual identity.

You have one more day to offer comments on the Food and Drug Administration’s proposal to change its policy on blood donations by gay and bisexual men.

A year ago, the FDA lifted its blanket ban on blood donations by any man who’d had sex with another man since 1977, a policy that had been in place since 1983 and was designed to keep HIV out of the nation’s blood supply. It replaced that with approval of donations by gay and bi men who are HIV-negative and had abstained from male-male sex for the previous year. Now it is considering a policy based on assessment of donors’ risk factors for HIV.

The FDA is specifically seeking input on the questions that should be asked to determine risk factors. The agency “recognizes that many stakeholders have expressed the desire to move from a time-based deferral period to a deferral policy based on individual risk assessment,” it says on the public comment website.

LGBT and AIDS activists had denounced the blanket ban as discriminatory and unscientific, and called the one-year deferral an improvement but still problematic. “Even though it was a great move to go from a lifetime ban to a one-year deferral — that was a hard-fought battle and the small change was a victory — we do still feel the current policy is more discriminatory and not fully based on current science,” Michael Czaczkes, director of policy and public affairs at Gay Men’s Health Crisis, told Pasadena, Calif., public radio station KPCC. GMHC would like to see the FDA change the deferral period to three months, as that allows enough of a window to determine if a donor has been infected with HIV,

The blood supply is thoroughly screened for HIV and other infectious diseases anyway, with highly sensitive tests that were not available in 1983, activists point out. And the ban and the subsequent deferral policy have prevented gay and bi men from donating blood even if they adhere to safe-sex practices, while people who are exclusively heterosexual can donate blood even if they engage in high-risk behaviors.

Some public health experts said that assessing all donors based on risk factors makes complete sense from a scientific standpoint. “Tens of millions of people donate blood each year, and they can either receive an education about HIV risk or miseducation,” Brad Sears, director of the Williams Institute at the University of California, Los Angeles, law school, told KPCC. “Right now they’re receiving miseducation; they’re receiving the message that who you are makes you at risk for HIV, instead of what you do.”

“All people who are anticipating donating blood or blood products should be evaluated based on their actual risk of spreading an infectious disease,” Dr. Jeffrey Klausner, a UCLA professor of medicine and public health, told the station.

Go to Regulations.gov to leave a comment through Friday.