On March 13, 2023, FDA issued a notice regarding guidance documents related to the COVID-19 pandemic, including which of the guidance documents will no longer be in effect after expiration of the declaration of the COVID-19 public health emergency (PHE). The notice followed a Department of Health and Human Services announcement on February 9 that it is planning for the declaration of the PHE to expire on May 11, 2023.1
In particular, FDA is announcing that COVID-19-related guidance documents will fall under one of the following three categories:
- No longer be in effect when the PHE declaration expires
- a) Revised to continue in effect for 180 days after the PHE declaration expires, then will no longer be in effect
b) Revised to continue in effect for 180 days after the PHE declaration expires, during which time FDA plans to further revise these guidance documents
- Will remain in effect when the COVID-19 PHE declaration expires
In more detail
FDA issued a number of guidance documents during the PHE to address the COVID-19 pandemic. Many of these guidance documents were tied to the PHE declaration. FDA’s notice addresses 72 of these COVID-19-related guidance documents that are currently in effect and specifies which of the guidance documents fall into the three categories described further below.
1. No longer be in effect when the PHE declaration expires
In the notice, FDA made clear that of the 72 guidance documents, 22 will no longer be in effect upon expiration of the COVID-19 PHE declaration, which is now expected to expire on May 11, 2023. Notable examples of these FDA guidance documents include:
- Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency (CBER)
- Development of Abbreviated New Drug Applications During the COVID-19 Pandemic—Questions and Answers (CDER)
- Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency (CFSAN)
The notice describes many reasons for why these guidance documents are no longer needed, including that many were issued to address supply chain disruptions which have been stabilized. Other guidance documents were issued to clarify recommendations tailored to specific considerations for the pandemic. FDA also noted that the science behind certain guidance documents has advanced and the agency may want to update these guidance to reflect these advances and new data.
2. Revised to continue in effect for 180 days after the PHE declaration expires
The notice also includes two tables to list the guidance documents that will be revised to continue in effect for 180 days after the PHE declaration expires and then will either (1) no longer be in effect or (2) the agency will further revise them. For the guidance documents that will no longer be in effect after the 180 days, the agency determined that an additional wind-down period is appropriate to allow industry to conduct an orderly transition away from the COVID-19 related guidance. There are 22 guidance documents that fall within this category. Several of these guidance documents relate to the use of remote assessments or monitoring devices or digital or telehealth systems or technologies used during the COVID-19 PHE.
Notable examples of these FDA guidance documents include:
- Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers (CDER)
- Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (CDRH)
- Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (CDRH)
- Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency (CFSAN)
There are 24 guidance documents that FDA intends to continue in effect after the expiration of the PHE, but to revise with any appropriate changes based on comments received and the agency’s prior experience in implementation.
Notable examples of these FDA guidance documents include:
- Emergency Use Authorization for Vaccines to Prevent COVID-19 (CBER)
- COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (CDER)
- Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry (CDER)
3. Will remain in effect when the COVID-19 PHE declaration expires
Finally, the notice includes a table of COVID-19-related guidance documents whose duration is not tied to the COVID-19 PHE and will remain in effect indefinitely when the COVID-19 PHE declaration expires. The guidance documents listed in this table are limited and include only four guidance documents issued by the agency:
- Product-Specific Guidances for Chloroquine and Hydroxychloroquine (CDER)
- Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic (CDER)
- Policy for Coronavirus Disease-2019 Test *Revised (CDRH)
- Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (CDRH)
The notice also addresses FDA’s draft guidance, Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency, that describes a proposed plan for devices that fall within the agency’s enforcement policies. Those enforcement policies are contained in certain device guidance documents issued during the PHE. FDA stated in the notice that it “intends to finalize the draft guidance as soon as practicable.”
- While guidance documents represent the agency’s current thinking on a matter, they do not establish legally enforceable rights or responsibilities. Nonetheless, companies who do not comply with agency guidance documents do so at their own risk and may be subject to increased risk of agency enforcement actions or litigation. Therefore, we recommend reviewing the notice and ensuring current policies and procedures align with the agency’s post-PHE guidance on a given topic.
- Companies should closely monitor FDA’s actions in relation to the guidance documents that the agency plans to revise and ensure that policies and processes are updated accordingly and in line with the future revisions.
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For further information and to discuss what this development might mean for you, please get in touch with the Baker McKenzie contacts provided above.
1 HHS, Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap (February 9, 2023), available at https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html#:~:text=Based%20on%20current%20COVID%2D19,day%20on%20May%2011%2C%202023.