The U.S. FDA has granted emergency use authorization (EUA) for thousands of products for the COVID-19 pandemic, and the agency is legally required to advise companies of their post-pandemic options for new marketing authorization. Conversely, companies that fail to deal with inventory for expired EUAs may find themselves in the crosshairs of the FDA, whistleblowers, and federal and state attorneys, suggesting that manufacturers of devices should have a plan for dealing with unused inventories once the public health emergency comes to an end.
Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said in November that the agency has a draft guidance in mind that will assist developers of tests in converting their EUAs into conventional premarket filings. However, Stenzel declined to predict when such a guidance might be published despite the intense interest in such a document, largely because OIR was still swamped with applications for tests of various sorts and other related matters.
Teresa Park, of counsel at the D.C. office of Covington & Burling LLP, said on a webinar hosted by the Food and Drug Law Institute (FDLI) that companies that have distributed EUA-only products during the public health emergency (PHE) will have to act to undertake some form of disposition of those products upon termination of the product’s EUA. This could be as simple as a notification to users or as demanding as a withdrawal of unused inventory. Immunity from product liability under the Public Readiness and Emergency Preparedness (PREP) Act is another factor that may create its own timeline. Since the PREP Act confers no authority to lawfully manufacture, distribute or use the affected products, there is no withdrawal of authority, but merely a cessation of protection from liability.
Despite the likelihood that most EUAs will expire simultaneously with the expiry of PREP Act immunity, there may be exceptions. If an EUA is terminated while the PREP Act is still in force, any product still available for use may or may not be immune to liability. Park said there may be some room for discussion between the manufacturer and U.S. federal authorities about the timing of liability in this scenario, but that the wording of the statute will be key to how those discussions unfurl.
If the EUA is still in force after the effective period of the PREP Act has passed, immunity may be unavailable to the manufacturer, Park said, while immunity is decisively unavailable for products for which the EUA has been terminated and the PREP Act is no longer in force. While it is reasonable to expect significant, if not complete, co-incidence of the expiration of EUAs and the expiration of PREP Act shielding against liability, any exceptions could prove extraordinarily problematic for the manufacturer.
One of the difficulties for regulated industries is that there are a number of entities in addition to the FDA that could engage in activities that more or less directly constitute enforcement. The list includes the House and Senate committees of jurisdiction, state attorneys general, and the U.S. Department of Justice. Whistleblowers are another potential source of disclosure regarding product availability after the EUA is no longer in force, Park said.
FDA must communicate re: post-EUA market access
Anne Walsh, director at the Washington office of Hyman, Phelps & McNamara, said the FDA is liable for formally notifying the sponsor of a termination of an EUA triggered by the termination of the PHE, thus removing any element of surprise. The statute also requires that the FDA consult with the manufacturer about a plan to manage the product’s availability via the EUA program in this scenario. The agency is further liable for providing the manufacture with a written explanation of any regulatory requirements for obtaining non-EUA marketing authorization of a product that has been in distribution under an EUA for at least one year at the end of the PHE. Whether the agency would voluntarily communicate with the sponsor about post-PHE access for products with less than a year under the EUA program is not clear, however.
In the past, the FDA has issued letters of termination of an EUA that provided some flexibility to use inventory that is still within the product’s labeled expiry, and Walsh said the FDA will accept data collected under an EUA to support a post-PHE regulatory filing. The agency had offered enforcement discretion in connection with the use of clinical laboratory tests that were distributed during the 2009 H1N1 flu outbreak, Walsh noted, although the products must still have been within expiry and must have already been in inventory at the site of service prior to termination of the EUA. Walsh said it is plausible to imagine the agency will offer a similar mechanism for unwinding inventories of EUA products in this pandemic.
Walsh noted that the National Defense Authorization Act of 2004 provided the FDA with the authority to allow a drug or device on the market based on a reasonable belief that the product in question “may be effective,” the standard for emergency use authorization (EUA). The intended use of any product thus granted market access is premised on labeling and/or the circumstances surrounding the distribution of the item. Walsh noted that the FDA has been working to rewrite the intended use regulation since 2017, when the agency posted a final rule that was blasted for introducing a standard not vetted by the rulemaking process that was part of the 2015 draft. The comment period for the latest draft rule has closed, but the history of the intended use problem suggests the FDA will require some months before bringing this latest draft to final form.
Past PHEs still in force
Walsh said the FDA has received in excess of 300,000 EUA inquiries for a variety of products for the COVID-19 pandemic, a sharp uptick over the handful of inquiries seen in previous communicable disease outbreaks to date in the 21st Century. The EUA for a given product is in force until the public health emergency expires or is withdrawn, or when the EUA is revoked by the FDA, whichever is earlier. However, she noted that of the 11 most recent emergency declarations, only three have been terminated, a fact which suggests that the PHE for the COVID-19 pandemic may prove quite durable. This has left in play all the emergency declarations since the 2013 declaration for Middle East Respiratory Syndrome Coronavirus (MERS-CoV), as well as those for the 2014 Ebola outbreak and the 2016 version for Zika. Two PHE declarations invoked to date in the 21st Century have run at least seven years, including the MERS-CoV declaration.
Walsh pointed out that the FDA can revoke an EUA for several reasons, including “other circumstances” as determined appropriate by the agency, so long as the FDA can reasonably claim it is doing so in the interest of public health. The alternative mechanism to the EUA mechanism has been enforcement discretion, which has been invoked numerous times during this pandemic. Products granted market access via the enforcement discretion mechanism face a greater legal risk than products authorized under the EUA program, Walsh said, because the enforcement discretion mechanism is less formal and is not specifically called out under the PREP Act.