On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency related to the novel coronavirus (SARS-CoV-2). On the basis of the February 4, 2020 HHS determination, FDA began exercising its Emergency Use Authorization (EUA) powers.
An EUA is a tool that allows FDA to facilitate availability and unapproved uses of “medical countermeasures” needed to prepare for and respond to chemical, biological, radiological, and nuclear threat agents. In the context of SARS-CoV-2, the EUA authority allows FDA to authorize the use of unapproved medical products or unapproved uses of approved products to detect and prevent the spread of SARS-CoV-2.
EUAs help address emergencies by lowering the barriers for bringing products to market. Throughout the years there have been several amendments to the legal basis for FDA’s EUA authority; section 564 of the FD&C was amended by the Project Bioshield Act of 2004, which was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017. In January 2017, FDA issued its current EUA guidance, which lays out when FDA can exercise EUA authority and the process for requesting an EUA.
Under the 2017 guidance, medical products may be considered for an EUA if FDA determines that the product “may be effective” to prevent, diagnose, or treat serious or life-threatening disease or conditions caused by chemical, biological, radiological, and nuclear threat agents identified in the HHS Secretary’s declaration of a public health emergency. Notably, the EUA standard (“may be effective”) is lower than the “effectiveness” standard that FDA requires for product approvals. Further, a product may be considered for an EUA if FDA determines that the known and potential benefits of the product, when used to diagnose, prevent, or treat life-threatening disease or conditions, outweigh the known and potential risks of the product. In making the determination of whether to grant an EUA, FDA will look at the totality of the scientific evidence related to the product. One important factor in FDA’s determination to grant an EUA for a given product is the availability of alternatives, which includes an examination of the adequacy of supply.
When submitting an EUA, FDA recommends including any available relevant scientific evidence related to the product. To date, FDA has issued EUAs for the following types of products in response to SARS-CoV-2: in vitro diagnostic products, personal protective equipment and decontamination systems, ventilators and “other medical devices,” and therapeutics. A list of all current EUAs is available on FDA’s website.
In Vitro Diagnostics EUAs
On February 29, 2020, FDA issued guidance on Diagnostic Tests for Coronavirus, which was updated on March 16, 2020. This guidance provides the requirements for SARS-CoV-2 testing and the process for FDA to issue EUAs for individual tests.
Under the EUA guidance, laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high-complexity tests may seek an EUA to develop and perform diagnostic tests to detect SARS-CoV-2. Notably, according to current FDA policy, the laboratory developed tests (LDTs) for detecting SARS-CoV-2 can be validated in a CLIA laboratory and used immediately, so long as the appropriate EUA is submitted to FDA within 15 business days.
Further, under the Diagnostic Test EUA guidance, commercial manufacturers may seek an EUA to develop and distribute diagnostic tests to detect SARS-CoV-2 to clinical laboratories or to healthcare workers for point-of-care testing. Notably, however, this policy does not apply to at-home testing. As with LDTs, under current FDA policy, the commercial manufacturer developed tests can be validated by the manufacturer and distributed immediately, so long as the appropriate EUA is submitted to FDA within 15 business days.
Finally, in the same guidance, FDA issued a policy explaining that FDA does not intend to object when developers of serological tests market or use their tests without prior FDA review where: (1) the tests are validated by the developer to determine that they are accurate and reliable, (2) notification of the developer’s validation is provided to FDA, and (3) the tests are labeled appropriately, including that they are not to be used as a sole basis for diagnosis. Therefore, when serological tests are conducted within the limited purposes outline by FDA, an EUA is not required.
As of April 21, 2020, FDA has issued 42 EUAs to test kit manufacturers and commercial laboratories, including the EUA Morrison & Foerster obtained for client BGI Genomics Co. Ltd, as well as 17 EUAs to LDTs. Templates for these EUA submissions are available online:
- “Accelerated” Template for Laboratories Certified to Perform High-Complexity Testing Under CLIA: EUA Template (updated March 6, 2020)
- Test Kit Manufacturer: EUA Template (updated March 12, 2020)
Personal Protective Equipment EUAs
On March 2, 2020, the HHS Secretary stated that current circumstances justify the authorization of emergency use of personal respiratory protective devices during the SARS-CoV-2 pandemic. Under this declaration, FDA has authorized the use of NIOSH-approved respirators; imported, non-NIOSH-approved respirators; non-NIOSH-approved respirators manufactured in China; face shields; and non-surgical facemasks.
On March 2, 2020, FDA authorized the use of all NIOSH-approved respirators for use in healthcare settings during the SARS-CoV-2 emergency. The authorization is specifically for HCPs and does not permit use of the authorized respirators by the general public. The authorization covers the use of:
- Non-powered air-purifying particulate filtering facepiece respirators (FFRs or “respirators”) and reusable respirators such as elastomeric half and full facepiece respirators, approved by NIOSH and listed on the NIOSH Certified Equipment List for non-powered air-purifying respirators with particulate protection;
- Other powered air-purifying respirators (PAPRs) approved by NIOSH and included on the NIOSH Certified Equipment List for PAPRs with particulate protection;
- FFRs that were NIOSH-approved but have since passed the manufacturers’ recommended shelf-life, are not damaged, and have been held in accordance with manufacturers’ storage conditions in strategic stockpiles; and
- Any authorized respirator under (1) or (3) above that has been decontaminated based on the terms and conditions of the authorized decontamination systems.
FDA updated its authorization on March 28, 2020 to include respirators decontaminated by authorized decontamination systems and to no longer require manufacturers of NIOSH-approved FFRs and strategic stockpilers to submit requests for authorization of their products to FDA. Instead, all manufacturers are authorized under the EUA, and they may contact FDA to withdraw some or all of their authorized model numbers from the EUA.
On March 24, 2020, FDA authorized the use of non-NIOSH-approved disposable FFRs by HCPs that either meet the performance standards of foreign jurisdictions or have marketing authorization in either Europe, Australia, Canada, or Japan. In contrast to the March 2, 2020 authorization for NIOSH-approved FFRs, this authorization is limited to the manufacturers listed in Exhibit 1, and manufacturers must send a request to FDA by email of their intent to import non-NIOSH-approved respirators. As of April 21, 2020, Exhibit 1 includes 5 authorized respirator models.
The March 24, 2020 authorization excluded non-NIOSH-approved FFRs manufactured in China; however, on April 3, 2020, FDA authorized the use of imported disposable FFRs manufactured in China that are not NIOSH-approved, and for which data exists that supports the respirators’ authenticity. Again, manufacturers must request to be added to Appendix A, which lists the authorized respirators. As of April 21, 2020, Exhibit A includes 87 authorized respirator models.
FDA has also authorized the use of face shields by HCPs and the use of non-surgical facemasks by both HCPs and the general public. Manufacturers of face shields and non-surgical facemasks covered by the authorizations do not need to contact FDA to request inclusion, but they must comply with the requirements of the authorization.
Ventilators and Other Medical Device EUAs
On March 24, 2020, the HHS Secretary declared that circumstances justify the authorization of emergency use of medical devices, including alternative products used as medical devices due to shortages during the SARS-CoV-2 outbreak. Under this declaration, FDA has authorized the use of ventilators and ventilator accessories; devices for decontaminating and reprocessing other devices; extracorporeal blood purification devices; and others.
On March 24, 2020, FDA authorized the emergency use of ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories. Products authorized under this EUA are added to Appendix B upon submission and review of a request from a sponsor as described in the Scope of Authorization included in the Letter of Authorization. As of April 21, 2020, FDA has added 33 ventilators, 3 ventilator tubing connectors, and 2 ventilator accessories to Appendix B.
On March 28, 2020, FDA authorized the use of the Battelle Decontamination System as the first system for decontaminating compatible N95 or N95-equivalent respirators for reuse by healthcare personnel. As of April 21, 2020, FDA has authorized the use of a total of 4 respirator decontamination systems.
As of April 21, 2020, FDA has authorized the use of 3 extracorporeal blood purification devices. FDA has authorized these devices based on the conclusion that they may effectively remove pro-inflammatory cytokines from the plasma to provide clinical benefit.
As of April 21, 2020, FDA has also authorized the use of:
- B. Braun Medical, Inc.’s infusion pumps for use in tracheal delivery of continuous nebulized medications into nebulizers to treat patients with SARS-CoV-2 and to decrease the exposure of HCP to such patients;
- Synapse Biomedical, Inc.’s diaphragmatic pacing stimulator system to assist in weaning patients off of ventilators in order to reduce the risks of prolonged mechanical ventilation and increase the availability of ventilators; and
- Lungpacer Medical USA, Inc.’s diaphragm pacing therapy system also to assist weaning patients off ventilators.
On March 27, 2020, the HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the SARS-CoV-2 pandemic. On March 28, 2020, FDA issued an EUA to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and used on select SARS-CoV-2 patients. As of April 21, 2020, FDA has only issued this 1 therapeutics EUA.
When the February 4, 2020 EUA declaration is terminated, any EUAs issued based on that declaration will no longer remain in effect. The HHS Secretary’s EUA declaration will terminate if SARS-CoV-2 circumstances cease or if the product for which the EUA was issued is no longer unapproved for the sought use. Before an EUA declaration terminates, the Secretary of HHS must provide advance notice to allow for the disposition of unapproved products and of labeling related to an unapproved use of an approved product. Although products like test kits may no longer be in existence because they were used already, products like ventilators may need to be recalled and destroyed. However, companies should consider the possibility of re-marketing products such as ventilators for approved uses.
Bringing products to the market in this post-market regulatory scheme may increase litigation risks. In response to these increased risks, and as we previously reported, on March 17, 2020, the Secretary of HHS issued a declaration pursuant to the Public Readiness and Emergency Preparedness (PREP) Act granting tort immunity to entities involved in creating and distributing “covered countermeasures” that address the current pandemic. 85 FR 15198. HHS issued an advisory opinion on April 14 to clarify the scope of the PREP Act declaration.
This declaration covers “any claim of loss caused by, arising out of, relating to, or resulting from” “covered countermeasures” for SARS-CoV-2. The term “covered countermeasures” is defined as any “qualified pandemic or epidemic product,” or a “security countermeasure,” or a drug, biological product, or device authorized for investigational or emergency use. Following amendment by the CARES Act, the PREP Act now also includes certain respirators as covered countermeasures. This declaration applies to “manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees, and the United States.” The declaration covers manufacturing, testing, development, and distribution from February 4, 2020 to (1) October 1, 2024 or (2) when the emergency declaration ends, whichever comes first.
Under the declaration, companies with SARS-CoV-2-related EUAs should qualify for protection. The declaration defines “qualified persons” as: “(a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction . . . to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency; (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act; and (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act” (emphasis added). However, immunity does not apply to serious physical injury proximately caused by willful misconduct and claims that do not arise directly from the development and distribution of a covered countermeasure. Immunity is also not available for claims where the U.S. has no jurisdiction.
Companies looking to understand their tort immunity protections under the PREP Act should consult legal counsel.
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