Faced with tremendous pressure during the coronavirus crisis to lift its policy barring gay men from donating blood, the Food & Drug Administration announced on Thursday it has eased the restrictions.
While the previous policy, established in 2015, barred men who have had sex with men in the 12 months from making a donation, the new policy would shorten the deferral period, requiring abstinence for only three months.
The FDA indicated it would make a change in a notice to stakeholders on Thursday, indicating the decision was based on “evaluation of the totality of the scientific evidence available.”
“To help address this critical need and increase the number of donations, the FDA is announcing today that based on recently completed studies and epidemiologic data, we have concluded that the current policies regarding the eligibility of certain donors can be modified without compromising the safety of the blood supply,” the notice says.
In addition changing the recommended deferral period for men who have had sex with men from 12 months to 3 months, the FDA informs stakeholders of other changes.
Among them are easing ban on donations for women who have had sex with men who, in turn, previously have had sex with a man. For these women the deferral period has similarly been changed from 12 months to 3 months.
Further, the new policy eases recommended 12 month deferral for individuals with recent tattoos and piercings to three months, and eases from an indefinite ban to a three month ban for donations from people who have a past history of sex in exchange for money, or injection drug use.
Other changes are implemented easing policy related to blood donors who have travelled to malaria-endemic areas, such as countries in Africa, or to European countries where the donors faces potential risk of transmission of Creutzfeldt-Jakob Disease or Variant Creutzfeldt-Jakob Disease.
The FDA issued the notice to stakeholders at the same time it published on its website a 17-page official memo outlining the changes, declaring they were made to address the shortage in the blood supply amid the COVID-19 crisis and therefore would not wait for a public comment period.
“As a result of this public health emergency, there is a significant shortage in the supply of blood in the United States, which early implementation of the recommendations in this guidance may help to address (even though the recommendations in this guidance are broadly applicable beyond the COVID-19 public health emergency),” the memo says.
The three month deferral period is consistent with recommendations from the American Red Cross, which before the coronavirus had called on the FDA to shorten the deferral period.