The FDA Eases Its Lifetime Ban on Blood Donations Based on Sexuality

In late December of 2014, the U.S. Food and Drug Administration (“FDA”) released a statement that it will be easing the lifetime ban on blood donations by gay and bisexual men. [1]  Under this new program, the deferral period for men who have sex with men to donate blood will be one year since their last sexual contact. [2] 

The lifetime ban on blood donations was put in place in the early 1980’s to prevent the spread of AIDS. [3]  The FDA’s former policy stated that any man who had sexual contact with another man after 1977 could not donate blood or plasma for the rest of his lifetime, whether or not he identified as homosexual or bisexual. [4] 

In June of 2013, the American Medical Association (“AMA”) passed a policy in opposition to the FDA’s lifetime ban on blood donations from men who have sex with men. [5]  To protect the blood supply and prevent the spread of HIV and AIDS through blood transfusions, the AMA supports a policy of imposing bans or deferral periods based on individualized risk levels, not sexual orientation alone.  [6] In this statement, AMA Board Member Dr. William Kobler, stated that the lifetime ban was, “discriminatory and not based on sound science.” [7]

Such an individualized risk assessment policy was enacted in Italy in 2001; the previous policy had been a lifetime ban on blood donations from men who have sex with men. [8]  A study by the National Institute of Health indicates this policy did not lead to a statistically significant increase in HIV-positive blood donations from men who have sex with men. [9]  Thus, this change in policy did not have an effect on the nation’s blood supply.  Under such an individualized policy, donors are evaluated based on the riskiness of their health decisions, regardless of their sexual orientation; for example, donors are evaluated based on their number of sexual partners with unknown sexual histories and their occurrences of unprotected sex. [10] 

With medical advances since the 1980’s, HIV can now be detected in blood donations much earlier and with greater accuracy. [11]  However, there is still a window period between infection and when the virus may be detected by blood tests. [12]  According to the American Red Cross, this period when an HIV-infected donor may not be detected through blood screening tests is seven to ten days. [13] 

While the original stated purpose of the lifetime ban on blood donations by men who have sex with men was to prevent the spread of AIDS, the FDA’s currently stated purpose for a deferral period is not only to prevent the spread of HIV and AIDS, but also to prevent the spread of Hepatitis C and Hepatitis B. [14]  Modern blood screening tests for these viruses impose one week and three to four week waiting periods, respectively, for which an infected donor may not be detected.  [15]

While the importance of these waiting periods between the last date of possible infection and blood donation is clear and serves to protect the integrity of the blood supply, there is a disparity between the twelve-month deferral period and the time periods for which these viruses may not be detected in an infected donor.  The FDA’s new deferral policy seems both under and over inclusive.  The policy is under inclusive by failing to limit the blood donations of high risk heterosexuals, and over inclusive by limiting donations from gay men in monogamous relationships and men whose potential infections would be detected by modern blood screening tests.  The FDA intends to issue guidance on this proposed change in policy sometime in 2015, in which the public will have an opportunity to comment. [16] 

Leah Sibbio is a student at DePaul University College of Law in Chicago and is a Fellow of the Jaharis Health Law Institute. Leah completed her undergraduate degree at the University of Pittsburgh in economics.


References:

[1] Margaret A. Hamburg, Press Announcements, U.S. Food and Drug Administration (Dec. 23, 2014), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427843.htm.

[2] Id.

[3] Revised Public Health Service Definition of Persons Who Should Refrain from Donating Blood and Plasma, Centers for Disease Control and Prevention (Sept. 6, 1985), http://www.cdc.gov/mmwr/preview/mmwrhtml/00000606.htm.

[4] Id.

[5] AMA Adopts New Policies on Second Day of Voting at Annual Meeting, American Medical Association (June 18, 2013),http://www.ama-assn.org/ama/pub/news/news/2013/2013-06-18-new-ama-policies-annual-meeting.page.

[6] Id.

[7] Id.

[8] Suligoi B. et al., Changing Blood Donor Screening Criteria from Permanent Deferral for Men Who Have Sex with Men to Individual Sexual Risk Assessment, National Institute of Health (July 11, 2013) http://www.ncbi.nlm.nih.gov/pubmed/23867178.

[9] Id.

[10] Kumanan Wilson et al., Three Decades of MSM Donor Deferral Policies. What Have We Learned? 18 Int’l J. Infectious Diseases 1, 1-3 (2014).

[11] Infectious Disease Testing for Donated Blood, American Red Cross,http://www.redcrossblood.org/learn-about-blood/blood-testing (last visited Mar. 24, 2015).

[12] Id.

[13] Id.

[14]  Blood Donations from Men Who Have Sex with Other Men Questions and Answers, U.S. Food and Drug Administration, http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/QuestionsaboutBlood/ucm108186.htm (last updated Dec. 23, 2014).

[15] Infectious Disease Testing for Donated Blood, American Red Cross,http://www.redcrossblood.org/learn-about-blood/blood-testing (last visited Mar. 24, 2015).

[16] Margaret A. Hamburg, Press Announcements, U.S. Food and Drug Administration (Dec. 23, 2014), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427843.htm.