FDA Policy: Men Who Have Sex With Men (MSM)

MSM Policy Video June 9, 2017
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Men Who Have Sex With Men (MSM) Fact Sheet

  • OneBlood’s role is to provide safe, available and affordable blood to its hospital partners and their patients.

  • The blood center is regulated by the Food and Drug Administration (FDA). As a regulated agency, OneBlood, like all blood centers in the United States, is required by law to follow all rules, guidelines and deferral policies put in place by the FDA.

  • If a blood center does not follow all of the FDA rules, the center would be in jeopardy of losing its license and could be shutdown.

  • Often people think it is the blood center that puts the rules in place, but in actuality, it is the FDA.

  • This includes the Men Who Have Sex with Men policy, or as it is commonly referred to as the MSM policy.

  • There are a number of FDA restrictions currently in place that mandate who can and cannot donate. The MSM policy is one of many policies.

  • Upwards of 60% of the population is not eligible to donate blood for one reason or another.  Travel, medication, sickness, high blood pressure or low iron, are a few of the other reasons a person may be deferred from donating.

  • In 2015, the FDA lifted its lifetime ban on men who have sex with men and moved to a one year MSM deferral policy.  A decision that OneBlood supported and has implemented.

  • OneBlood is one of four large blood centers who have received a multi-center research agreement to identify and further characterize risk factors in blood donors who are infected with HIV and hepatitis. This research will permit an effective and focused assessment of risk for all potential blood donors, regardless of their sexual orientation.

  • OneBlood is also actively participating in the development of research studies on individual donor risk assessments, rather than blanket policies that cover all MSM who present to donate.  These studies will collect additional information to guide future blood donation policy rules, including the practicality of individual risk assessment for all donors.

  • Persons who were deferred under the previous lifetime deferral policy for MSM and now may meet the new one year MSM deferral policy, must contact the OneBlood Donor Advocacy team to have their donor profile updated in our computer system. If the donor’s profile is not updated accordingly, the person will remain deferred.  It is strongly recommended that people contact Donor Advocacy before attempting to donate so the most current information is reflected in our computer system in advance of a donation attempt. 

  • The Donor Advocacy team can be reached at 1.888.936.6283 extension 33858.  Team members are available Monday – Friday between 8:00am and 4:30pm.

  • Donors and the general public can contact the FDA’s Center for Biologics Evaluation and Research toll free at 1 (800) 835-4709.

  • Or write to:

Office of Communications
CBER/OCTMA (HFM-40)
Food and Drug Administration
1401 Rockville Pike, Suite 200
North Rockville, MD 20852

For the Food and Drug Administration’s position on the MSM policy visit: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/QuestionsaboutBlood/ucm108186.htm

 

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