That is going to be difficult because Remdesivir was under an Emergency Use Authorization, and was covered by the "PREP Act"
PREP ACT OVERVIEW
The PREP Act provides immunity from personal injury, business disruption, or property damage claims (except willful misconduct) to individuals or organizations broadly involved in the development, testing, manufacture, distribution, or dispensing of drugs, biologics, and devices intended for use for COVID-19 or program planning around such products.
To be covered by PREP Act immunity, the COVID-19-related activities and products must meet the criteria set forth in the US Department of Health and Human Services (HHS)
declaration of immunity from liability, published March 17, 2020 and
amended on April 15 (the Declaration). HHS also later issued an
advisory opinion on April 17, which was updated on May 19, to provide further clarity on the breadth of the Declaration (the Advisory Opinion).
KEY FACTORS AND DEFINITIONS
The Declaration describes several detailed criteria and definitions for liability immunity under the PREP Act; thus, it is important to assess applicability on a case-by-case basis. Key definitions from the Declaration include, for example, the following:
Covered Countermeasures. PREP Act liability immunity is tied to “covered countermeasures.”
- Covered countermeasures are defined to include the following:
- Any drug, biologic including vaccines, or medical device product or respiratory protective device used to treat, diagnose, cure, prevent, or mitigate COVID-19 or SARS-CoV-2 (or a virus mutating therefrom);
- Any device used in the administration of any such product; and
- All components and constituent materials of any such product.
- Covered countermeasures may include certain products related to, or intended to support, COVID-19 prevention, treatment, or diagnosis, including, for example:
- A product intended to diagnose, mitigate, prevent, or treat a serious or life-threatening disease or condition caused by a COVID-19 therapeutic; or
- A product or technology intended to enhance the use or effect of another COVID-19 covered countermeasure (e.g., drug or vaccine adjuvant).
- To qualify as a covered countermeasure, the drug, biologic, or device must be approved or cleared by FDA, or authorized for investigational or emergency use by FDA, for COVID-19-related purposes.
- Respiratory protective devices must be approved by the National Institute for Occupational Safety and Health (NIOSH).
Covered Persons. PREP Act liability immunity is available to “covered persons,” defined to include the following:
- “Manufacturers,” which is broadly defined to include any contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool, or component or other article used in the design, development, clinical testing, investigation, or manufacturing of a covered countermeasure; and any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.
- “Distributors,” which is defined to include any entity engaged in the distribution of covered countermeasures, such as manufacturers, repackers, common and contract carriers, own-label and private label distributors, jobbers, brokers, warehouses, wholesalers, and retail pharmacies.
- “Program planners,” which can include state or local governments and private sector employers or groups that supervise or administer a program, establish standards, or provide policy guidance relating to a covered countermeasure.
- “Qualified persons,” which includes persons authorized to prescribe, administer, or dispense covered countermeasures, such as physicians, nurses, pharmacists, technicians, and other healthcare providers.
Recommended Activities. PREP Act liability immunity is available to covered persons engaged in “recommended activities,” including the following:
- The manufacture, testing, development, distribution, administration, and use of the covered countermeasures.
- Administration of covered countermeasures includes not only physical administration of products and services, but also activities and decisions directly relating to public and private delivery, distribution and dispensing of the covered countermeasures, management and operation of covered countermeasures programs, or management and operation of locations for purpose of distributing and dispensing covered countermeasures.
