As noted in our client alert in November, FDA released a draft guidance and a final guidance on October 29, 2021, related to the reporting manufacturing volume data for drugs and biologics as required under the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”). In the draft guidance, FDA advised registrants that the 2020 calendar year production volume reports were due by February 15, 2022, and 2021 calendar year reports were due by May 16, 2022. For the years thereafter, the reports are due annually by February 15 of the following calendar year.
On February 14, 2022, FDA updated its CARES Act Drug Shortage Mitigation Efforts website with the following note:
FDA is considering comments to our draft guidance on Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, including comments about the recommended timelines for submitting the required reports. The draft guidance document is not a binding document, and the recommended February 15, 2022 reporting date for 2020 data is not a requirement. We are carefully reviewing all issues raised by stakeholder comments to the docket, including regarding the recommended reporting timeframes. We will consider updating the draft guidance's recommended timeframes for reporting, as appropriate, along with other issues raised by such stakeholder feedback.
While FDA guidances are generally non-binding documents, this note confirms that FDA will continue to exercise enforcement discretion for reporting manufacturing volume data under the CARES Act. The relevant provision of the Act went into effect on September 23, 2020.
In response to its draft guidance, FDA received many comments, including those related to the reporting timeframes, from various stakeholders.
While this will give registrants additional time to prepare, registrants should continue preparations for compliance with the volume reporting requirements. It is worth noting that the America COMPETES Act passed by the House, if enacted, would change the reporting requirements from annually to quarterly (the Senate has yet to take up this bill).
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.
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