Over the course of 2020, the Food and Drug Administration (FDA) released numerous guidance documents covering diverse areas and aimed at increasing the availability of various medical products to prevent, treat, and diagnose COVID-19. Some of our prior blog posts on those pandemic response activities implemented by FDA can be found here and here. In all of those actions, FDA made clear that the agency’s enforcement discretion policy was temporary, or that an emergency use authorization (EUA) was being granted pursuant to statutory criteria that include a requirement that there be “no adequate, approved, and available alternative to the product,” which by definition renders the EUA temporary, as well. Accordingly, several EUAs granted to diagnostic tests, therapeutic products, and medical devices have been revoked based on a determination that all of the criteria necessary to support emergency authorization under the statute can no longer be met. And although the public health emergency is not over even as 2021 comes to a close, FDA has kept its promise to continually reassess circumstances and needs on the ground in the United States and to modify policies and emergency authorizations as necessary.
Notably, early on in the pandemic FDA’s Center for Drug Evaluation and Research (CDER) developed and released multiple enforcement discretion policies intended to increase the supply of alcohol-based hand sanitizer by, in part, allowing non-traditional manufacturers to produce these non-prescription drug products. In mid-October 2021, the agency announced via a statement by the CDER Director that “the supply of alcohol-based hand sanitizer from traditional suppliers has increased, and now, most consumers and healthcare personnel are no longer having difficulty obtaining these products. Therefore…it’s appropriate to withdraw the temporary guidances and [we] are providing manufacturers time to adjust their business plans related to production of these products under these temporary policies.” (A Federal Register notice announcing the withdrawal of those enforcement discretion policies was also published and is available for review here.) It’s also worth pointing out that CDER has identified a significant amount of serious adulteration in alcohol-based hand sanitizers over the past year or so, leading to many recalls and import alerts, which almost certainly contributed to this regulatory decision as well.
Unless they plan to stay in the business and to comply with all applicable drug manufacturing requirements starting next year, however, non-traditional hand sanitizer producers do not need to wind down these operations as quickly as they most likely created and ramped them up back in 2020. FDA’s recent announcement offers not only advance notice to those entities but also a post-withdrawal grace period during which any remaining stocks of hand sanitizer produced under the temporary policies can be sold and distributed. In particular:
- All of the temporary COVID-19 guidance documents pertaining to hand sanitizers are withdrawn effective December 31, 2021.
- Companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of such products by that date.
- Any entities wishing to continue producing hand sanitizer after December 31, 2021 must do so in compliance with the Tentative Final Monograph for Topical Antiseptics and with good manufacturing practice regulations for human drugs, among other potentially applicable requirements.
- Any entities ceasing their production of hand sanitizer in parallel with FDA’s withdrawal of the temporary policies must deregister and delist to ensure that public records are updated to show that those products are no longer in commerce.
- Hand sanitizers produced before December 31, 2021 under the temporary guidances must no longer be sold by their manufacturers to wholesalers or retailers by March 31, 2022. Any remaining undistributed hand sanitizers produced under the temporary policies after March 31, 2022 should be destroyed, according to a Q&A for Industry also published by the agency concurrently with the announcement and Federal Register notice.
- On the other hand, retailers who may have purchased and are in possession of hand sanitizers manufactured under the temporary policies do not have to take any actions after the March 31, 2022 sell-through deadline for manufacturers. The Q&A for Industry states clearly that even after April 1, 2022, “retailers may continue to sell their stock of hand sanitizer produced under the guidances. Withdrawing the guidances is not a requirement to recall all hand sanitizer produced under the temporary policies.”
Another example of FDA’s shifting focus towards ending some of the regulatory flexibilities it put into place to respond to the emerging public health emergency last year is the recent posting of upcoming guidance document priorities for the Center for Devices and Radiological Health (CDRH). Two of the draft guidance documents CDRH plans to issue over the next 12 months are entitled “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency” and “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the COVID-19 Public Health Emergency.” Recent public remarks by policymakers within CDRH have indicated that some of the agency’s goals are to ensure that these transitions are orderly, transparent, and risk-based.
Entities who took advantage of any FDA enforcement discretion policies or have been granted emergency authorizations to market medical countermeasures in response to the COVID-19 pandemic should make note of these announcements by the agency and take appropriate steps to prepare for the end of those temporary pathways. This is especially the case for entities that are interested in continuing to market those products when the relevant temporary policy or authorization is no longer available to them.