Government and Regulations
The Food and Drug Administration announced finalized blood-donor deferral guidance that includes cutting the deferral for men who have sex with men from indefinitely to 1 year from the most recent sexual contact of this type.
The finalized guidance, which had been in development since its initial announcement in December 2014, contains 10 recommended questions that the blood industry should pose to potential donors to exclude those at greatest risk for potentially transmitting HIV in their blood.
In addition to reducing the deferral period for men who have had sex with men, the finalized guidance also cuts the deferral period for a woman who has had sex with a man who had sex with men from indefinitely to 12 months, and also reduces the deferral period for any person who has had sex with someone with a history of a positive test for HIV from indefinitely to 12 months.
The new guidance continues to recommend indefinite deferral for people who have ever tested positive for HIV, those who have exchanged sex for money or drugs, and those with a history of nonprescription injection drug use.
The FDA’s guidance document highlights that these are recommended steps for the blood products industry to take and are not required by law or legally enforceable.
The finalized guidance, which followed a public comment period on essentially unchanged draft guidance issued last May, received quick support in a statement from Dr. Andrew W. Gurman, president-elect of the American Medical Association.
“The American Medical Association commends the U.S. Food and Drug Administration for ending the lifetime ban that prohibits men who have had sex with men from donating blood,” Dr. Gurman said. “The AMA has been a strong advocate for eliminating public policies that do not align with scientific evidence and best ethical practices in public policy. The FDA’s final guidance takes important steps to improve the balance among ensuring health equity, engaging with high-risk populations, and protecting the safety of the national blood supply.”
However, a highly critical comment came from Daniel Bruner, senior director of policy for Whitman-Walker Health, a Washington-based health center focused on the LGBT community and HIV care.
“Although some may argue that a 12-month ban is better than a grossly outdated lifetime ban, the updated policy is still discriminatory and not rooted in the reality of HIV testing today,” Mr. Bruner said in a statement. “As we called for in our recommendations, the deferral period should be no longer than 30 days, given that with current testing technology an HIV infection can be detected in donated blood within several weeks of exposure.
“And even then, those that would be subject to the deferral period should be able to donate blood if they agree to return for an HIV test 30 days after donating,” Mr. Bruner said. “Sadly, and also not in line with modern science, the new guidelines continue the discriminatory lifetime bans on individuals who have ever engaged in sex work or ever used nonprescription injection drugs.”
Mr. Bruner added, “We are also disheartened that the FDA has failed to give clear guidance to prevent discrimination against transgender individuals, which occurs too often at blood donation centers. The FDA must do better than this slow chipping away at antiquated bans.”
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