“Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so,” said FDA Commissioner Dr. Robert Califf on Friday. The Washington Post reported the news earlier.
The American Medical Association had criticized the FDA’s restrictions on gay men donating as discriminatory.
“At issue is the need to evaluate all potential blood donors on an equal basis based on their individual risk factors and without regard to their sexual orientation or gender identity,” said Dr. Gerald Harmon with the AMA in January of 2022.
The Human Rights Campaign, the nation’s largest organization that advocates for LGBTQ rights, said the FDA proposal is a step in the right direction, but more needs to be done to to remove restrictions.
“We urge the Biden administration to prioritize removing remaining barriers and ask the FDA to move expeditiously while ensuring the safety of the blood supply and a blood donation policy in-line with the science,” said HRC President Kelley Robinson in a statement.
People who are taking oral medications to prevent HIV infection would not be allowed to donate blood for the three months following their most recent dose. Those taking injections to prevent HIV would not be allowed to donate blood for two years following their most recent injection.
These medications, called pre-exposure prophylaxis or PrEP, can result in false negatives on HIV tests, according to the FDA.
Under the proposed FDA policy, anyone who has tested positive for HIV or taken medicine to treat an HIV infection would be banned from donating blood. People who have engaged in sex work or used illicit intravenous drugs recently would have to wait three months to donate.
Blood banks would still be required to test all donations for HIV as well hepatitis C and B, according to FDA.
Dr. Peter Marks, a senior FDA official, said the agency is evaluating the science to increase the number of people who are eligible to donate blood while maintaining safeguards that ensure the supply is safe for recipients.
“We will continue to follow the best available scientific evidence to maintain an adequate supply of blood and minimize the risk of transmitting infectious diseases and are committed to finalizing this draft guidance as quickly as possible,” Marks said on Friday.
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