FDA submits final recommendations for adjusting MSM blood donation deferral periods
Presently, blood donation rules state men who have had sexual contact with another man any time after 1977 are excluded from blood donation as a means of quelling HIV transmission through donated blood products. The U.S. Food and Drug Administration (FDA), however, is looking to change that deferral period to 12 months.
"The FDA's responsibility is to maintain a high level of blood product safety for people whose lives depend on it," FDA acting commissioner Dr. Stephen Ostroff said. "We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply."
Final recommendations on the matter were issued by FDA officials on Dec. 21. With that, the agency has requested that blood donation facilities revise any materials to reflect the new guidelines.
The recommendation was made after extensive studies of epidemiological data.
An April letter to FDA's consumer affairs branch, which was penned by American Academy of Family Physicians' then-board chair Dr. Reid Blackwelder, called the blood donation standards regarding MSM "not scientifically justifiable" and noted many potential donors were turned away because of them.
"In reviewing our policies to help reduce the risk of HIV transmission through blood products, we rigorously examined several alternative options, including individual risk assessment," Dr. Peter Marks, deputy director of the FDA's Center for Biologics Evaluation and Research, said in the news release. "Ultimately, the 12-month deferral window is supported by the best available scientific evidence at this point in time, relevant to the U.S. population. We will continue to actively conduct research in this area and further revise our policies as new data emerge."
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