It’s a burning question: when will we return to normal? And although the answer is hugely subjective, this post focuses on the date the official emergency declaration for COVID-19 will terminate. Despite the general sentiment that we want to be back to normal sooner rather than later, precedent reveals that the termination of an emergency declaration can take years. Indeed, many public health crises that now seem historic, like Ebola or Zika, remain subject to a Public Health Emergency Declaration, with some extending over seven years. This lengthy duration is not a bad thing, however, as the emergency status supports the continued distribution of medical products subject to an Emergency Use Authorization (EUA).
As background, in 2004, through the National Defense Authorization Act, Congress established a program to permit during times of emergency the sale of a drug, biologic, or medical device that lacks FDA approval, license, or clearance. This program, codified in section 564 of the Federal Food, Drug, and Cosmetic Act, allows FDA to authorize the use of an unapproved drug, biologic or medical device when alternative therapies are not available. The criteria for issuance of an EUA are lower than the standards FDA typically requires for product approval and, among things, only requires a showing that there is a “reasonable belief” that a product “may be effective.” 21 U.S.C. § 360bbb-3(c).
The Secretary of HHS published a statement in February 2020 declaring that there is a public health emergency involving the virus that causes COVID-19. See 85 Fed. Reg. 7316 (Feb. 7, 2020). This Declaration serves as the basis for hundreds of EUAs, including face masks and other personal protective equipment, ventilators, remdesivir, convalescent plasma, and most recently vaccines.
Companies have relied on these EUAs, some of which are tied to a specific product and others that provide an “umbrella” authorization for whole product categories, to build up infrastructure and distribution chains to bring these necessary products to market. But there is uncertainty about how long these companies can rely on the EUA as its marketing authorization. Under the statute, an EUA is effective until 1) the Secretary terminates the declaration or the company obtains approval for the product; or 2) FDA revokes or revises the EUA based on its determination that the circumstances supporting the EUA no longer exist. See 21 U.S.C. § 360bbb-3(f)(1). This post provides perspective on when the first criterion might occur.
Since 2005, there have been 11 declarations of a public health emergency under the FDC Act. The chart below lists in chronological order the type of emergency and the date HHS issued its declaration.
|Public Health Emergency||Section 564 Declaration|
|H1N1 Influenza (Swine Flu)||4/27/2009|
|H7N9 Influenza (Bird Flu)||4/19/2013|
|Middle East Respiratory Syndrome Coronavirus (MERS-CoV)||5/29/2013|
|Enterovirus D68 (EV-D68)||2/6/2015|
|Freeze Dried Plasma||7/9/2018|
Of the 11 public health emergencies since 2004, HHS has terminated only three: two for Anthrax and one for H1N1. The other public health emergency declarations remain open, and products marketed under EUAs for these emergencies continue to be available to the public.
The bar chart below shows the duration of each recent public health emergency (the data were run back in November 2020). In context, the short tenure of the COVID-19 emergency (just shy of a year) in comparison with Bird Flu (approaching 8 years), makes us reasonably confident that HHS will not terminate the COVID-19 declaration any time soon. The pace in which vaccines and treatments have become available could change the calculus, of course.
And even if the Secretary decides to terminate the emergency declaration, the statute provides some comfort to companies selling products pursuant to an EUA that they will not be left in the lurch with huge inventories of unapproved product. The Secretary must provide advance notice that a declaration will be terminated, and that period of advance notice must reasonably provide sufficient time for disposition of the product or relabeling, as needed. 21 U.S.C. § 360bbb-3(b)(3). Thus, the program has built-in a safety mechanism for companies to manufacture and distribute unapproved products pursuant to EUAs without fear that the rug could be pulled out from underneath them.