Over the past month, in response to the COVID-19 pandemic, the US Food and Drug Administration (“FDA”) has invoked its statutory authority to issue a series of Emergency Use Authorizations (“EUAs”) that allow the distribution of certain products for use in the diagnosis, prevention, and treatment of COVID-19 that could not otherwise be distributed for those purposes. Manufacturers and distributors of such products should be aware of the (sporadically updated) EUAs and their limits.
In general, products that are intended to diagnose and treat disease may not be distributed in the United States absent FDA authorization. Although authorization to distribute drugs and medical devices may be obtained via various regulatory routes depending on the product in question, obtaining such authorization is usually a time-consuming endeavor, as the manufacturer must demonstrate the product’s safety and efficacy under the conditions stated in the product’s proposed labelling.
Moreover, although the law regarding so-called “off-label” promotion is unsettled, the FDA has taken the position that distribution of an authorized drug or device for a use other than one specified on its FDA-approved label can constitute evidence of unlawful “misbranding” under 21 U.S.C. § 352(f), which could expose the distributor to civil and criminal enforcement actions.
Given the current shortage of ventilators, masks, diagnostic tests, and other items needed to combat COVID-19, adherence to the generally applicable authorization rules would impede efforts to end the pandemic. For example, although there is a severe shortage of N95 masks, which the CDC recommends that healthcare workers wear to avoid contracting COVID-19, it could be considered unlawful to distribute N95 masks for use in a healthcare setting if those masks were originally intended for industrial rather than medical uses and had been approved by the National Institute for Occupational Safety and Health (“NIOSH”) rather than the FDA.
To alleviate that problem, the FDA has recently issued several EUAs permitting the distribution of products that could not otherwise be distributed lawfully for use in combatting COVID-19. The EUAs cover certain masks, ventilators, diagnostic tests, and drugs. It is important for companies considering the manufacture and distribution of such items to understand what the EUAs allow and what they require.
To gain that understanding, a quick overview of the statutory regime governing EUAs is helpful. EUAs are governed by 21 U.S.C. § 360bbb-b. Before an EUA may be issued, there must be a determination by a designated agency head that there is a domestic, military, or public-health emergency. Once the requisite emergency determination has been made, the Secretary of Health and Human Services is authorized to issue EUAs permitting the manufacture and distribution of otherwise unauthorized products for use in combatting the declared emergency. To issue an EUA, the Secretary must make certain findings in consultation with other officials. Among other things, the Secretary must find, “based on the totality of scientific evidence available to the Secretary,” that the product “may be effective in diagnosing, treating, or preventing” the disease in question; that “the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by” the disease; and that “there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease.” When issuing an EUA, the Secretary must, “to the extent practicable” under the circumstances, impose conditions on the distribution and use of products covered by the EUA that are “necessary or appropriate to protect the public health.”
On January 31, 2020, the Secretary of Health and Human Services issued a determination that a public-health emergency exists—and has existed since January 27—as a result of the COVID-19 pandemic. Pursuant to that determination, the Secretary has issued EUAs covering different products for use in diagnosing, treating, and stopping the spread of COVID-19. The EUAs cover products falling into four categories: personal protective equipment; other medical devices; diagnostic products; and, therapeutics.
Some EUAs—those covering personal protective equipment and other medical devices—address entire categories of devices. Others—those covering diagnostic products and therapeutics—are specific to a particular test or drug. Each EUA defines the otherwise unauthorized product or products that may be lawfully distributed during the declared emergency and the conditions imposed on such distribution. The EUAs that address categories of products define the classes of products that are eligible for emergency use authorization, establish streamlined processes for obtaining FDA emergency use authorization to distribute a particular product within a defined class, and (in principle) list the particular products that have received emergency use authorization. Each EUA imposes certain conditions on the distribution of the product or products in question—conditions that typically involve labelling, recordkeeping, and reporting requirements. At the same time, each EUA expressly waives certain otherwise applicable requirements, such as those requiring adherence to the FDA’s Current Good Manufacturing Regulations (codified at 21 C.F.R. Part 820) and the FDA’s registration and listing requirements (codified at 21 C.F.R. Part 807).
COVID-19-related EUAs are available on the FDA website, which has been regularly updated as new EUAs are issued. For several weeks, the website had also contained links to the associated lists of particular products approved for distribution pursuant to the respective EUAs. Unfortunately, as of today at least, most of those links have disappeared.
Thus far (this is written on April 6, 2020), the FDA has issued four EUAs for personal protective devices, three that cover certain categories of respirators (i.e., masks) and another that covers a particular decontamination process for such respirators. An EUA originally issued March 2 and reissued on March 28 in expanded form authorizes—subject to certain conditions—the distribution of certain NIOSH-approved respirators. Another EUA, originally issued March 24 and also reissued on March 28 in expanded form, authorizes—again, subject to certain conditions—the distribution of certain respirators that have not been approved by NIOSH but have been approved by certain other regulatory agencies. Finally, the most recent EUA, permits the distribution of certain masks without NIOSH approval that are manufactured in China.
As of now, one EUA has been issued permitting, subject to various conditions, the distribution of certain ventilators and associated accessories. The products covered by the EUA are either not currently marketed in the US or are marketed in the US but require modification for use against COVID-19. Although the links to other such lists have (at least for the moment) disappeared from the FDA website, the list of products currently approved for distribution under this EUA is still available (at least for the moment).
To date, thirty-two diagnostic products have received EUAs. Of those, twenty-eight are in vitro products and four are molecular-based tests. As noted above, each diagnostic EUA is specific to a particular product.
Finally, the FDA has issued an EUA authorizing the use of chloroquine phosphate and hydroxychloroquine sulfate distributed from the Strategic National Stockpile to public health authorities for administration to patients by a licensed healthcare practitioner.
The EUAs described above give manufacturers who want to distribute products that could help fight COVID-19 but are not otherwise authorized for such use by the FDA the opportunity to do so. Before distributing such products, however, manufacturers must be sure to consult the requirements and limitations set forth in the relevant EUA. Manufacturers that fail to do so risk possible liability.
If you wish to receive periodic updates on this or other topics related to the pandemic, you can be added to our COVID-19 “Special Interest” mailing list by subscribing here. For any other legal questions related to this pandemic, please contact the Firm’s COVID-19 Core Response Team at FW-SIG-COVID-19-Core-Response-Team@mayerbrown.com.