The Food and Drug Administration (FDA) is not exactly an agency that I associate with doing a job well done. Multiple FDA regulations got in the way of this country's response to the pandemic. Then there is the FDA's e-cigarette regulations, drug importation laws, and the FDA exacerbating the continuing baby formula shortage. And what about its proposals to ban trans fats or menthol cigarettes? As much as I have criticized the FDA over the years, the FDA actually did something good last week.
Since 1985, the FDA had a policy to ban blood donations from gay and bisexual men, also known as men who have sex with men (MSM). This ban was implemented in the heyday of the newly emerging human immunodeficiency virus (HIV). Blood services need to ensure that any blood for transfusion purposes is safe. Back then, the FDA saw a strict donation ban on the MSM population to be a way to ensure that safety. Since the MSM population continues to have a higher incidence of HIV, it is the main reason as to why the ban has remained for years.
In 2015, that went from a lifetime ban to a one-year ban due to improved screening quality. In 2020, that ban was decreased to three months because of the shortage of blood during the pandemic. As of last week, the FDA has been completely eliminated, which makes me happy with the FDA. Donors will no longer be discriminated based on their sexual orientation.
Instead, each individual donor will be asked about their sexual history in the past three months, regardless of their sexual orientation. First, a potential donor will be asked if they have had more than one sexual partner or a new sexual partner within the past three months. If they answer in the affirmative, they will then be asked if they had anal sex. If they respond yes, their donation will be deferred.
Not only eliminating the ban is something that the Red Cross and American Medical Association have supported, but this move by the FDA is actually based in science. I had made the argument back in 2014 that we should get rid of this ban, and I will reiterate much of it here today.
As of now, the window period for HIV to show up on a HIV test is three months, hence the three-month period of the current screening. It also did not make sense to ban monogamous homosexual individuals from donating blood while allowing promiscuous heterosexual individuals to donate blood. This new FDA regulation resolves the double standard by focusing on individual behavior instead of sexual orientation.
Another area where I feel better about this choice is with the risk of HIV infection vis-à-vis transfusion. When I reported on this topic in 2014, the probability of infection was about 1 in 2,000,000. With improved screening since then, it stands to reason that the probability is lower than it was back then. As a matter of fact, I came across a paper that calculates that it can be as low as 1 in 8,000,000 for developed nations (Robbins Scott and Wu, 2019). As technology gets better, the risk of infection will get lower.
The truth is that the blood supply is always vulnerable and there is always going to be demand for blood donations. The most recent FDA regulation strikes the balance between safety of the blood supply and maximizing the blood supply. I could end with a "better late than never" attitude, but I am glad to see we can end a form of discrimination against the MSM population while helping greater society by alleviating blood shortages.
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