FDA Issues Guidance Documents Directed to Blood Donations as Part of COVID-19 Public Health Emergency Measures

To address critical shortages of blood and plasma during the COVID-19 pandemic, the U.S. Food and Drug Administration (the “FDA”) released several guidance documents on April 2, 2020.  Specifically, the FDA is relaxing procedures associated with the release of blood and blood components by blood/plasma collection facilities, and is expanding who may qualify as a donor by reducing deferral periods for several populations, including gay men, those with tattoos and piercings, and travelers to malaria-endemic countries.

Alternative Procedures Guidance

The FDA’s Guidance, “Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency” (the “Alternative Procedures Guidance”), provides for three exceptions to regulations governing the release of blood and blood components by blood or plasma donation centers:

• The FDA now permits the release of donations made by “ineligible donors” who could have suffered adverse effects from donating their blood, e.g., persons with low blood pressure, low pulse rate, or who are underweight, or those who have donated blood too frequently. Donation centers screen potential donors before drawing blood to make sure their health would not be affected by donation.  The FDA still requires such pre-screening under the new Alternative Procedures Guidance, but if a mistake is made in evaluating donor eligibility and a donation is nevertheless collected, the donation center may now release the donation for use.  Prior to the issuance of the Guidance, such blood or plasma was ineligible for release.
• The quarantine hold time for source plasma from paid donors prior to release is reduced from 60 days to 45 days. This permits donation centers to release source plasma more quickly to meet current needs.
• Donation centers have up to 72 hours from the time a donation is collected to shore up donor records, i.e., confirm that the donor was eligible to donate if their response to screening is unclear or certain information was omitted. Prior to the issuance of the Guidance, the donation center was required to clarify its records within 24 hours of donation.

To implement the change in procedures, licensed donation centers must submit a Changes Being Effected Supplement to the FDA.

HIV Risk Guidance

The “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Product” (the “HIV Risk Guidance”) reduces the amount of time that a potential donor must wait (defer) before donating blood and blood products after engaging in certain activities or potentially being exposed to the HIV virus.

The HIV Risk Guidance reduces the deferral time required prior to donation to three months from the last date of the activity or exposure event.  As support for the shortened deferral, the FDA assessed data regarding the risk of transmission and infection of HIV through blood donation, and the advances in testing that permit HIV, HBV, and HCV to be detected well within three months of infection.  The following potential donors may now donate with a three month deferral: 

• Male donors who have had sex with another man in the prior three months. The previous recommendation was a deferral of 12 months.
• Female donors who have had sex in the prior three months with a man who has had sex with another man in the prior three months.
• Donors who were recently been tattooed or had ear or body piercing. No deferral is required if the tattoo was applied by a state-regulated practice with sterile needles and ink not previously used. Those who have had ear or body piercing also do not need to defer if the piercing was performed with single use equipment.  Previous guidelines relating to tattooing and piercing required a 12 month deferral.
• Donors who have received an allogeneic transfusion of whole blood or blood components.
• Donors exposed to another person’s blood, such as by a needle stick or contact with wounds, etc.
• Donors who perform commercial sex work or have used drugs by injection. Previous guidelines required indefinite deferral.
• Donors who have had sexual contact with a person who has tested positive for HIV, performed commercial sex work, or engaged in non-prescription injection drug use.
• Donors who have completed treatment for syphilis or gonorrhea.

The HIV Risk Guidance continues to recommend indefinite deferral for any donor who has tested positive for HIV, and donation centers also must continue to test donations for evidence of HIV infection.  Donation centers can adopt the recommendations in the HIV Risk Guidance after they revise their donor history questionnaire and related materials as specified in the Guidance.  Licensed centers also must provide a Changes Being Effected Supplement and an annual report to the FDA.

Malaria Risk Guidance[1]

The “Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria” (the “Malaria Risk Guidance”) reduces the recommended amount of time that a potential donor must wait before donating blood and blood products after having malaria or visiting or residing in a malaria-endemic country.

Previous recommendations required indefinite deferral for donors who have had malaria or have possible exposure to the contagion as a result of travel to, or residing in, a malaria-endemic country, with a few exceptions made for areas of Mexico.   Because the FDA has approved devices that can reduce the presence of the pathogen in donated plasma and platelets (“pathogen reduction devices”), and the low risk of transmission, the Malaria Risk Guidance  expands donations as follows:

• For donors who are residents of non-endemic countries, but have traveled to a malaria-endemic area, the FDA recommends a deferral from donation for three months after the departure from the malaria-endemic area. Alternatively, no deferral is needed if a pathogen reduction device is used on the donation.
• For donors who are prior residents of malaria-endemic countries, have resided in a non-endemic country for more than three consecutive years, and have traveled to a malaria-endemic area, the FDA recommends a deferral of three months from the time they return to the non-endemic country. Alternatively, a deferral is not necessary if an FDA approved malaria-reducing device is used on the donation.
• For donors who are prior residents of malaria-endemic countries, have resided in a non-endemic country for less than three consecutive years, and have traveled to a malaria-endemic area, the FDA recommends a deferral of three years.
• For donors who previously resided in malaria-endemic countries, the FDA recommends a three year deferment from donation.
• For donors with a history of malaria, the FDA recommends deferment of three years as long as the donor has been residing in an non-endemic country.

Donation centers can adopt the recommendations in the Malaria Risk Guidance after they revise their donor history questionnaire and related materials as specified in the Guidance.  Licensed centers must report changes in a Changes Being Effected Supplement and submit an annual report to the FDA.

As the COVID-19 crisis evolves, Seyfarth Shaw attorneys are closely monitoring the FDA’s reactions to the situation.  We are available to protect your interests, help you mitigate risks and liabilities, and keep you informed regarding the latest implications related to the COVID-19 crisis. Visit our Resource Center for more information.

[1] The FDA also published guidance relating to Creutzfeldt-Jakob disease (“CJD”) or variant Creutzfeldt-Jakob disease (vCJD) easing restrictions on donation for those potentially exposed to the disease or related to those with the disease.  CJD and vCJD are rare neurogenerative diseases transmitted by prions (misfolded proteins).