FDA Relaxes Blood Donation Requirements

3 Apr 2020

On April 2, the Food and Drug Administration (FDA) announced that, effective immediately, it is modifying its current policy to shorten the abstinence period, from 12 months to 3 months, for men who have sex with men (MSM), and for women who have sex with MSM, before they can donate blood.  This announcement comes as social distancing and shelter-in-place policies have caused a dramatic reduction in the number of blood donations, causing a shortage in the U.S. blood supply.

In 1983, the FDA enacted a ban on blood donations from MSM.  At that time, there was no way to test whether blood donations contained HIV.  As the knowledge of HIV and scientific technology progressed, the FDA implemented new guidance which allowed MSM to donate blood, but required them to abstain from sex for the prior 12 months.  This time-based restriction has long been criticized for being discriminatory and not scientifically sound.  In response to COVID-19’s impact on the U.S. blood supply, many public health organizations urged the FDA to change this policy and last week a group of Senators wrote a letter to the FDA encouraging it to end the discriminatory blood donation policy and “shift to scientific practices that secure our nation’s blood supply based on individual risk rather than the perpetuation of inaccurate stereotypes.”

In support of its policy change, the FDA stated that it had “concluded that current policies regarding certain donor eligibility criteria can be modified without compromising the safety of the blood supply.”  The relaxed waiting period will continue through the duration of the COVID-19 public health emergency.

Category: Drug Pricing

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