FDA Collection And Labeling Protocols For Use Of Convalescent Plasma As A Treatment For COVID-19

• Published date: 21 May 2020
• Author: Mr Robert Terzoli, Jamaica Szeliga and Dean L. Fanelli Ph.D.
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Coronavirus (COVID-19), Food and Drugs Law, Government Measures, Reporting and Compliance
• Law Firm: Seyfarth Shaw LLP

The U.S. Food and Drug Administration has provided guidance for health care professionals to use convalescent blood plasma from patients who have recovered from COVID-19 as a potential treatment for currently infected COVID-19 patients. The 'Investigational COVID-19 Convalescent Plasma Guidance for Industry' ('Guidance') explains the investigational new drug application (IND) pathways for this treatment, which Seyfarth has previously addressed in an update. In this article, Seyfarth summarizes the Guidance recommendations on how to properly obtain and label COVID-19 convalescent plasma.

Collection

COVID-19 convalescent plasma INDs must meet FDA's IND regulations relating to chemistry, manufacturing, and control information (see 21 CFR 312.23(a)(7) and 21 CFR 312.305(b)(2)(vi)). To meet these requirements, FDA recommends that IND applications include information that the COVID-19 plasma to be used will be obtained from FDA-registered blood establishments that follow the proper donor eligibility criteria and donor qualifications for the plasma and also that the plasma to be used will have an acceptable concentration of antibodies.

Registered and licensed blood establishments that collect plasma intended for transfusion do not need to supplement their license or obtain their own IND to collect and manufacture COVID-19 convalescent plasma, so long as they 1) follow their standard procedures for plasma collection and all applicable regulations, and 2) collect plasma from individuals that meet the donor qualifications specified in the Guidance, which would be included in the applicable IND(s) held by a health care provider or other sponsor

Donor qualifications for COVID-19 convalescent plasma are provided in detail in the Guidance. These requirements generally require that:

• the donor has a documented case of COVID-19 confirmed from an approved laboratory test,
• the donor has a resolution of symptoms for a specified period of time,
• the donor has a properly tested absence of HLA antibodies, and,
• where available, the donation contains an appropriate amount of neutralizing antibody titers.

Labeling

COVID-19 convalescent plasma must be properly labeled. FDA provided several...