Regulatory Insights on COVID-19 Updates From FDA

Mar 26, 2020

For Sponsors with Products Intended to Treat Indications Other than COVID-19

Posted by Veristat, LLC

In this unique time, with many health authorities, governments and pharmaceutical companies focused on the global pandemic and how to prevent, diagnose and treat COVID-19, it is important to remember the number of therapies currently in development or already approved for the multitude of other diseases affecting people worldwide.  FDA has issued several press releases and guidance that affect Sponsors running or planning clinical studies, those planning marketing applications and those with products already on the market.  We summarize here valuable information that is important for drug and biologic companies to be aware of as they continue to try to make these therapies available to patients. 

22 March 2020 – Coronavirus (COVID-19) Update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency

FDA is communicating with sponsors and prescribers that they are providing additional flexibility in terms of handling REMS requirements. “FDA recognizes that during the COVID-19 public health emergency, completion of REMS-required laboratory testing or imaging studies may be difficult because patients may need to avoid public places and patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine.” Health care providers and prescribers are being asked to use their judgment regarding REMS requirements for laboratory testing or imaging during this time, and to communicate with their patients regarding these judgments, including the risks associated.

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19 March 2020 – Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic – FDA Guidance for Industry

For Sponsors with products that are already on the market, the FDA acknowledges that workforces will be reduced during the current pandemic.  This guidance discusses FDA’s intended approach to enforcement of adverse event reporting requirements during a pandemic.  FDA has revised the final guidance for industry entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic”, which was finalized in 2012, to become applicable to any pandemic. FDA states in this guidance that “normal adverse event reporting processes should be maintained to the maximum extent possible”

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19 March 2020 – Updated Instructions for Submitting Lot Release Samples and Protocols for CBER-regulated Products During the COVID-19 Pandemic

The Center for Biologics Evaluation and Research intends to pause certain lot release activities and will not be receiving biological product samples or protocols in physical form.  CBER’s Office of Compliance and Biologics Quality (OCBQ) has provided manufacturers with logistical information to assist with continuation of the lot release process during this period.

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18 March 2020 – FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

In recognition of the difficulties of running clinical trials during the COVID-19 pandemic, FDA has issued guidance for Sponsors conducting these studies.  Please see Veristat’s summary of this guidance here for additional information.

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18 March 2020- FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections – FDA Statement

With the fast-rising number of COVID-19 cases around the world resulting in travel restrictions, FDA announced on March 10th that it is postponing inspections through the end of April. FDA has said domestic travels will be limited to “mission critical only” and foreign inspections will be considered on a case by case basis. On March 18th, with the growing incidence of cases in the US, FDA announced that all routine domestic inspections will be halted but the agency will use all available authorities to ensure the safety and quality of products for the protection of public health. For those awaiting pre-approval inspection, the delay and uncertainty of when the inspections will resume affects the timeline for the approval and may have many consequential impacts. 

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16 March 2020- Public Meetings; Postponement, Cancellation, or Remote – Federal Register

The FDA Center for Drug Evaluation and Research (CDER) has announced that it would be canceling, postponing, or virtually hosting upcoming meetings due to the COVID-19 pandemic as well as for all “non-essential” meetings through April.  It has been Veristat’s experience that FDA is converting formal meetings with Sponsors from face-to-face to teleconferences.

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