Letter to the Hon. Dr. Stephen Hahn, Commissioner of the Food and Drug Administration - Oversight Committee Urges FDA to Revise Policy Preventing Gay and Bisexual Men from Donating Plasma for Coronavirus Research

Letter

Dear Commissioner Hahn:

We urge the Food and Drug Administration (FDA) to immediately modify its donor
deferral recommendations to allow all men who have sex with men (MSM) who have recovered
from coronavirus and can safely donate plasma in support of treatment research efforts to do so.
FDA's current policy--which recommends turning away all MSM if they have been sexually
active in the past three months--stigmatizes gay and bisexual men and undermines critical
research into potential coronavirus treatments.

On April 1, 2020, Chairwoman Carolyn B. Maloney and Representative Alexandria
Ocasio-Cortez sent a letter urging you to revise FDA's donor deferral policy for MSM in light of
the negative long-term impacts coronavirus will have on the United States blood supply. The
next day, FDA announced that it would shorten this deferral period from twelve months to three
months.

Shortening the MSM deferral period was a good first step. However, FDA's policy
continues to exclude gay and bisexual men who can safely donate blood and blood products--
including those who have recovered from coronavirus and can donate plasma to support
treatment research efforts.

Although FDA has not approved any coronavirus treatments, there are currently more
than a dozen ongoing clinical trials evaluating the efficacy of transfusing antibody-rich plasma from patients who have recovered to treat current patients. To further this research, FDA has
been working with the American Red Cross to encourage people who have recovered from
coronavirus to donate plasma.

FDA's current blanket deferral policy--which does not evaluate potential donors on the
basis of individual risk--directly undermines critical efforts to develop an effective treatment for
coronavirus. There is no scientific justification for denying MSM who have recovered from
coronavirus the opportunity to safely donate plasma. Yet, gay and bisexual men who have
recovered from coronavirus and attempted to donate have been turned away in accordance with
FDA's blanket deferral recommendation.

To ensure that efforts to develop an effective coronavirus treatment can proceed
unhindered, we urge FDA to immediately modify its deferral recommendations so that all gay
and bisexual men who have recovered from coronavirus and can safely donate plasma to support
treatment research efforts are able to do so.

The Committee on Oversight and Reform is the principal oversight committee of the
House of Representatives and has broad authority to investigate "any matter" at "any time" under
House Rule X. If you have any questions regarding this request, please contact Committee staff
at (202) 225-5051.