REGULATORY UPDATE: FDA Releases Investigational COVID-19 Convalescent Plasma Guidance

The Food and Drug Administration recently released the guidance “Investigational COVID-19 Convalescent Plasma” to provide recommendations to health care providers and investigators on the use of COVID-19 convalescent plasma (CCP) or investigational CCP, and recommendations for blood collection establishments. 

The recommendations outlined in the guidance remain unchanged from the January 2022 guidance that it supersedes. However, FDA removed language limiting the duration of the policy in the guidance to the public health emergency related to COVID-19, declared by HHS in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)), which expired May 11. 

The expiration of the public health emergency does not affect FDA’s ability to authorize medical countermeasures or emergency use under section 564 of the FD&C Act. An emergency use authorization (EUA) issued under section 564 of the FD&C Act (including for CCP) remains in effect for the duration of the relevant EUA declaration, unless FDA chooses to revoke the EUA because the criteria for issuance are no longer met, or revocation is appropriate to protect public health or safety. 

During the recent “Ask the FDA” session at the 2023 AABB Annual Meeting, FDA recommended that, “In preparation for when the EUA is no longer in effect, blood establishments interested in submitting an IND or biologics license application for COVID-19 convalescent plasma may contact the Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR). In addition, we intend to issue a guidance with recommendations for such submissions.” 

Members with questions about the new guidance and its policies are invited to contact AABB’s Regulatory Affairs Department at regulatory@aabb.org.