COVID-19 and Use of Investigational Drugs

Please note that information and guidance can evolve rapidly as part of the COVID-19 pandemic. Please visit the U.S. Food and Drug Administration (FDA) website for the latest information and contact the HRPP with any questions. 

Please note that the FDA regulations for clinical investigations of drugs (21 CFR 312) do not apply to the use in the practice of medicine for an unlabeled indication of an FDA approved drug or biological product. 21 CFR 312.2(d)

Emergency Use of an Investigational Product

Emergency use means the use of an investigational product on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval. Emergency use of an investigational product is permitted without IRB review so long as the emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review.

See HRPP Manual Section 7-3, Emergency Use of Investigational Drugs and Devices for the MSU HRPP requirements. 

NOTE: THIS USE REQUIRES IRB REVIEW OR NOTIFICATION. CONTACT THE MSU HRPP REGARDING THIS USE.

Expanded Access

The FDA permits expanded access of an investigational product to facilitate the availability of such drugs to patients with serious disease or condition when there is no comparable or satisfactory alternative therapy. An expanded access submission is required for each type of access (individual, intermediate, treatment) and may be a new IND or an amendment to an existing IND. IRB review is required, either prospectively or in the case of an emergency request, treatment may begin without prior IRB approval, provided the IRB is notified of the emergency treatment within 5 working days of treatment.

  • Individual patient, including emergency use, permits use of the investigational drug in the treatment of an individual patient by a licensed physician.

  • Intermediate-size patient populations permits use of the drug for a patient population smaller than the typical treatment IND or treatment protocol.

  • Treatment IND or treatment protocol permits use of the drug for widespread treatment.

COVID-19

Although participation in clinical trials is one way for patients to obtain access to convalescent plasma, these may not be readily available to all patients in potential need. Therefore, given the public health emergency that the expanding COVID-19 outbreak presents, while clinical trials are being conducted, FDA is facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug Applications (eINDs) for Individual patients.

For the process, visit the FDA Investigational COVID-19 Convalescent Plasma - Emergency INDs website. It includes the process for both requests that are not highly time sensitive and the event of an emergency that is highly time sensitive (response required in less than 4 hours).

Other drug sponsors may also be making investigational products available through expanded access. Contact the sponsor for the process.

NOTE: THESE USES REQUIRE IRB REVIEW OR NOTIFICATION. CONTACT THE MSU HRPP REGARDING THIS USE.

Developing Therapeutic Products to Treat COVID-19

Submission to, and review by, the FDA of an investigational new drug application (IND) is needed to conduct a clinical investigation of an investigational drug, unless the activity meets an FDA exemption. Any use of a drug except for the use of a marketed drug in the course of medical practice is a clinical investigation. IRB review and approval is required for clinical investigations.

See HRPP Manual Section 7-1, Research Involving Investigational Drugs and Devices for the MSU HRPP requirements. 

COVID-19

If an investigator would like to participate in a collaborative clinical investigation being conducted under a master protocol, contact the MSU HRPP. While a central IRB may be used for the study, reliance on a central IRB still requires submission to the MSU HRPP and sign off. Please notify use as soon as possible so we can quickly move forward on the reliance process.

If an investigator would like to develop a new therapeutic drug for use in a clinical investigation, including a new unapproved use or indication of an already FDA approved drug product, contact the FDA and the MSU HRPP as soon as possible. The MSU HRPP may consider use of a central IRB for these kinds of studies. Visit the FDA COVID-19 Therapeutics: General Information for Interested Stakeholders website for information.

NOTE: THIS REQUIRES IRB REVIEW. CONTACT THE MSU HRPP REGARDING THIS USE.

Emergency Use Authorizations

The Emergency Use Authorization (EUA) authority allows the FDA to help strengthen the nation’s public health protections against chemical, biological, radiological and nuclear threats by facilitating the availability and use of medical countermeasures needed during public health emergencies.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological and nuclear threat agents when there are no adequate, approved, and available alternatives.

COVID-19

FDA Emergency Use Authorizations are updated frequently during the COVID-19 pandemic, so please visit the FDA website for Emergency Use Authorization for the latest information. 

Emergency use authorizations would not require IRB review if used in the practice of medicine for an unlabeled indication of an FDA approved drug. Contact the MSU HRPP with any questions.

Webpage last updated: 9/28/2020