Orlando, Florida
May 11, 2023
OneBlood supports the U.S. Food and Drug Administration’s (FDA) decision to implement a gender-inclusive, individual assessment of all donors to reduce the risk of HIV in the blood supply. The change has been decades in the making and means restrictions that make it challenging for gay and bisexual men to donate blood will be eliminated.
The current FDA policy known as Men Who Have Sex with Men (MSM) requires gay and bisexual men to wait three months following their last sexual contact with another man to donate blood. The new FDA policy will eliminate the time-based restriction of three months and instead screen all potential donors equally, using a series of questions that will assess their individual risk of HIV, regardless of gender or sexual orientation.
“The FDA’s shift in policy is the start of a new era of blood donor eligibility,” said Susan Forbes, senior vice president of corporate communications and public relations. “Individual assessment of all donors will maintain the safety of the blood supply, make blood donation more inclusive, ensure all donors are treated equally and enable more people the opportunity to donate blood.”
-Susan Forbes
Senior VP of Corporate Communications & Public Relations
The FDA’s new donor eligibility policy is in line with blood donation policies currently in place in the United Kingdom and Canada.
Safety of the blood supply is OneBlood’s top priority. All blood donations undergo more than a dozen tests to ensure donations are safe for patients, including HIV, Hepatitis B and C, West Nile and other infectious diseases. Testing takes place at OneBlood’s state-of-the-art testing facility, Creative Testing Solutions (CTS). Click HERE for our story about the CTS Laboratory.
Timeline to Implement New Policy
OneBlood has been anticipating the FDA’s announcement and has already begun to make the required changes to their regulated software platform to implement the new Donor History Questionnaire (DHQ) and will soon begin the required training for frontline team members.
“OneBlood looks forward to implementing the FDA’s new guidance and is moving as quickly as possible to make the necessary changes. We anticipate being ready to begin accepting donors under the new policy in the coming months. In the meantime, the current three-month restriction for men who have sex with men will remain in effect,” said Forbes.
OneBlood Helped Lead the Way
Three of the nation’s largest blood centers, OneBlood, Vitalant and the American Red Cross enrolled nearly 1,600 gay and bisexual men into the groundbreaking ADVANCE Study. The data gathered from the two-year study was provided to the FDA and contributed to the FDA’s decision to eliminate the time-based restriction and move to an individual assessment of HIV for all donors.
OneBlood partnered with the LGBTQ+ Centers in Orlando and South Florida to enroll participants into the study.
“OneBlood is proud to have helped lead the way towards a new era in donor eligibility. We are grateful to the LGBTQ+ community for their partnership and are grateful to the study participants for their willingness to be enrolled. They should take great pride in knowing they were part of a groundbreaking study that contributed towards making blood donation more inclusive while maintaining the safety of the blood supply,” said Forbes.
Next Steps
History of FDA’s MSM Policy