Originally reported Thursday, March 3 and updated Wednesday, June 15 with updated timeline details — Six months after the Food and Drug Administration eliminated a decades-long ban on gay and bisexual men donating blood, the restriction is effectively still in place in St. Louis and across the country.
In a widely publicized move last December, the FDA changed its recommended policy to allow men who have sex with other men to donate blood only if they have abstained from sex for a year.
But for the change to take effect, blood centers across the country — and the St. Louis area — first have to update the questionnaires for screening donors, education materials and other informational documents.
The FDA must approve those changes “that have a substantial potential to affect the identity, strength, quality purity or potency of the product as they relate to the safety and effectiveness of the product,” according to an agency spokeswoman in an email in March.
The FDA said the general timeline for review of those changes is 12 months, but could be completed sooner. The agency also said it was up to individual blood centers to determine how and how long it will take to implement the new recommendations.
Local blood centers vary on timeline
Several organizations in the region could not give a specific deadline for when they will implement the new recommendations. The American Red Cross, likely the biggest organization for blood donations in the St. Louis and Metro East areas, is “working to determine a process for the reinstatement of eligible donors who were deferred under the previous MSM policy,” external communications manager Dan Fox said earlier this year.
“It will take several months for blood centers to update their computer systems, modify processes and procedures, train staff and implement these changes,” he said in an email in March. “We do not have a set date for when these changes will go into effect.”
An email seeking an update sent Wednesday was not immediately returned.
Octapharma Plasma Inc., with a location in Hazelwood, said in March it is reviewing the FDA’s guidance and “working on a timeline and plan for implementation.” An email sent Wednesday seeking more information was not immediately returned.
At least one organization did have an anticipated deadline in place, but has since had to push it back. Mississippi Valley Regional Blood Center, which has donor centers, mobile operations and distribution centers in St. Peters, Crestwood, Maryland Heights and Maryville, Ill., said it had hoped to have its updates completed by the end of June, but the process will take at least another couple of months.
Pete Luxe, senior director of donor services, said his organization uses the donor history questionnaire prepared by the trade organization AABB (American Association for Blood Banks). Approval of those updates to the AABB’s materials, which would then allow any organization using them to begin implementation, were expected by late March or early April.
But Kirby Winn, public relations director, said in an email Wednesday that the FDA approval only came through in late May, "a bit later than what we would have hoped."
"So while it’s good news that we now have the approved UDHQ [Uniform Donor History Questionairre] to work with, we are now targeting late summer (August or September) to implement the changes that will allow us to move forward with the change to the MSM deferral," Winn wrote.
That's because, Luxe explained, the Mississippi Valley Regional Blood Center must now review procedures and train staff “to understand the impact and how to have this discussion with donors” about the FDA’s end of the ban.
Once the changes are implemented, the organization simply must report them to the FDA in its annual report.
Winn also noted Wednesday that the blood center had seen a recent uptick in donations, most likely due to "increased awareness and support for blood donation following the mass shooting in Orlando" in a gay nightclub.
Not many missed opportunities
Even though it will take his organization at least a few more months to implement the new process, Luxe said in March he hadn’t seen very many people go to donate under the new rules and be turned away.
“We haven’t had very many, but we have told them we are modifying those processes…they’ve been okay with it,” said Luxe. “I can think of one who called to find out when it would happen for us, because he did understand it wouldn’t happen overnight.”
Likewise, the National Gay Blood Drive has seen only isolated cases of men going to donate under the new recommendations and being turned away, according to director of communications Jay Franzone.
“This is ending a decades-long lifetime ban on gay men giving blood, so with that we expected it to be a little bit time consuming,” he said in March. “It’s a very complex process.”
Luxe said the policy change still requires a one-year deferral for gay and bisexual men, so he doesn’t anticipate “a flood of new donors” trying to donate immediately.
Still he said the year-long abstinence requirement is “more current with science” than the previous outright ban, since there is more knowledge about how HIV is transmitted, how long it can be present in the body before it is detected, better screening and testing. He said the new 12-month deferral is similar to deferrals in place for other reasons.
“A man who has sex with a woman, who actually has HIV – that’s only a one-year deferral, not a permanent deferral,” he said. “It’s falling in line with the other reasons we defer people for other high-risk behaviors.”
Perceptions of discrimination
But Franzone said the one-year deferral, like the lifetime ban before it, is still “based blatantly on sexual orientation” and not on science or the current testing available.
Dale Wrigley of the St. Louis Effort for Aids agrees: “It stigmatizes a group of people based on who they are not necessarily on their behavior or their sexual risk or health risk.”
Wrigley said in March even men who are in a monogamous relationship or are married would not be able to give blood without a year of celibacy.
“Medically the testing is so much more improved and the window period, the time from testing to infection, is so much lower and that blood is tested at least twice after being donated,” he said.
Wrigley said because many people view even the updated recommendations on blood donor eligibility as discriminatory, he believes people have been donating anyway.
“They want to do that, not to put the system at risk, but they do (donate) because of the discrimination of the rule,” he said. “People did donate because they had been regular donors and they were tested regularly and they were negative and so they knew that.”
FDA outreach
Both Wrigley and Luxe agree that the FDA could have done more to let the public know that the recommendations wouldn’t be implemented immediately. Wrigley said the changes come “without any marketing, without any outreach to gay men.”
Luxe said it has put the onus on the individual blood centers to explain the delay.
“I think it would have been nice for the FDA to say, ‘Although we’ve made this change, it will take up to six months for blood centers to implement this change,’ and unfortunately the FDA I don’t believe has sent out that kind of communication,” he said. “So we are kind of stuck with that explaining to donors or potential donors, ‘Yes, you will be able to donate, but not until we make this change.'”
Franzone said the National Gay Blood Drive has been advising people through its website that the process will take several months. He also said the new recommendations open the doors for even further changes down the line.
“The FDA and (the Department of Health and Human Services) have been much more transparent and committed themselves to looking at these new technologies and these new systems of blood donor deferral processes, such as individualized risk,” he said.
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