FDA Provides Guidance on How to Request Authorization to Use Convalescent Plasma as a Treatment for COVID-19

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Convalescent blood plasma from patients who have recovered from COVID-19 is a potential treatment that has gained scientific interest. Because COVID-19 convalescent plasma has not yet been approved by FDA, it is regulated as an investigational new product. In order to legally administer convalescent plasma, a health care provider must do so under an investigational new drug application (IND).

To speed research into COVID-19 convalescent plasma, FDA published “Investigational COVID-19 Convalescent Plasma Guidance for Industry” (“Guidance”) for health care professionals looking to use convalescent blood plasma as a treatment for COVID-19. FDA laid out three pathways under which health care providers may properly administer or study the use of COVID-19 convalescent plasma: clinical trials, expanded access, and single patient emergency INDs. 

IND pathways

Clinical trials

Clinical trials are the traditional pathway under which investigators study most new treatments. The proper way to initiate clinical trials are well laid out in 21 CFR Part 312. Such requests are being reviewed expeditiously by FDA. 

Expanded access

An IND application for expanded access allows for the use of COVID-19 convalescent plasma in patients with serious or immediately life-threatening COVID-19 disease who are not eligible or who are unable to participate in randomized clinical trials (21 CFR 312.305).

FDA has worked with multiple federal agencies and organizations, along with academia, to establish an expanded access protocol to facilitate access to COVID-19 convalescent plasma across the nation. Currently, a nationwide protocol is in place. Health care professionals and patients can access the National Expanded Access Treatment Protocol website to determine eligibility and find additional information about the protocol. Indeed, the website provides information to health care professionals on how to register as a provider, receive COVID-19 convalescent plasma, and how to properly administer treatment, monitor patients, and submit reporting documents. 

Single patient emergency IND

When these pathways are not readily available to a patient in need, a patient’s licensed physician may request a single patient emergency IND (eIND) for the individual patient to receive COVID-19 convalescent plasma under 21 CFR 312.310. 

FDA provided specific instructions to providers applying for a single patient eIND depending on the time of day and urgency of the request. First, a provider applying for a single patient eIND must determine that the probable risk to the person from the COVID-19 convalescent plasma is not greater than the probable risk from COVID-19 (21 CFR 312.310(a)).  Once this has been determined, the provider should complete and submit Form FDA 3926 (https://www.fda.gov/media/98616/download) with as much information as possible (including, for example, diagnosis, current therapy, rationale for using COVID-19 convalescent plasma, and from where the COVID-19 convalescent plasma will be obtained). 

Applications submitted via email to FDA on Form FDA 3926 between 8 a.m. EST and 8 p.m. EST will receive a response within 4 hours. If accepted, a confirmatory email with the emergency IND number will be sent. 

Requests between 8 a.m. EST and 8 p.m. EST where the provider is unable to complete and submit Form FDA 3926 due to extenuating circumstance may contact FDA’s Office of Emergency Operations via telephone (1-866-300-4374) to seek verbal authorization. 

For overnight requests between 8 p.m. EST and 8 a.m. EST, providers may contact FDA’s Office of Emergency Operations via telephone (1-866-300-4374) to seek verbal authorization. In this instance, the requestor must agree to submit an expanded access application within 15 working days of FDA’s authorization of use. 

Patient eligibility for an emergency IND is similar to the eligibility criteria used for the National Expanded Access Treatment Protocol, including laboratory confirmed COVID-19, severe or life-threatening COVID-19, and informed consent provided by the patient or healthcare proxy. 

Records

In addition to the IND requirements laid out above, a health care provider participating in an IND must maintain records for the COVID-19 convalescent plasma unit(s) administered to the COVID-19 patient pursuant to the requirements set forth in 21 CFR 312.62. Among other information, records must indicate the unique identifier for the plasma unit and the dates, quantity, and use of the plasma with patients.  Case histories that record observations and other data for the patients receiving the plasma also must be maintained.

The COVID-19 crisis is a fluid situation generating a multitude of issues on a daily basis. Seyfarth regulatory attorneys are closely monitoring the situation around the clock. 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 COVID-19 Resource Center for more information.