If you received one or more reminder emails in November 2024 asking your firm to submit 2023 CARES Act reports, you are not alone. In 2024, the FDA emphasized the importance of CARES Act reporting and the Agency’s need for the data contained in those reports at several conferences, but there have continued to be questions as to what the Agency is going to do with the information. The emails seem to provide some clarification but may have also caused confusion.
As a reminder, in February 2024, the FDA finalized the Guidance for Industry (GFI) Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act. This GFI stated that reporting for Calendar Year (CY) 2023 was to be submitted no later than August 5, 2024, then subsequent years’ reporting is to be submitted no later than March 31 of the following year. With the final version of the GFI now in place, the FDA expects that firms will comply with the law, and it is addressing non-reporting and discrepancies via e-mail.
Going back to those emails from November 2024, generally, they stated one of the following and included a list of National Drug Codes (NDCs):
- You have NDCs drug listed for your establishment but did not submit the required CARES Act report for one or more NDCs.
- You submitted a CARES Act report for CY 2023; however, there were discrepancies between the NDCs included in the report and your drug listings.
It’s important to remember that the drug listing and CARES Act reporting requirements are from the same section of the FD&C Act (The Act). What Lachman has observed in these communications is that the FDA is using the information received in drug listings and comparing that information to what is being reported under the CARES Act. If there are discrepancies between the two, the FDA is requesting that the firm resolve the discrepancies. The requirement to submit a CARES Act report is directly tied to a facility’s registration with the FDA as a drug product or a drug substance (DS/API) manufacturer. Therefore, any errors or inconsistencies in the drug listing database that the FDA used to compile the list of NDCs that it compared to the CARES Act submitted reports were carried over into the round of emails it sent. The FDA assumed that the data was correct, but many listings may be out of date or have errors, which could include, for example, failure to discontinue listings, which may have led to discrepancies. This may not be how the FDA or industry thought this notification process would unfold, but it is serving a purpose by revealing these inconsistencies and showing industry the importance of maintaining accurate drug listings. There doesn’t appear to be a timeline requirement for making these corrections; however, your future reporting will be easier if any drug listing discrepancies are resolved quickly.
Lachman is also aware that the FDA included DS manufacturers in the email notifications sent in November. These requested that the DS manufacturers provide CARES Act reporting on finished product NDCs for which they are not responsible. DS manufacturers are only responsible for reporting products that they manufacture and import to the U.S. and they should include “0” values if nothing was manufactured or imported that year for a given NDC; however, some drug listing files for finished drug products may still be using the older “manufacturer” business operation for the DS manufacturer instead of “API manufacturer.” This caused significant confusion with DS manufacturers and should be corrected in future drug listings to prevent CARES Act noncompliance notifications from being sent to DS manufacturers. Unfortunately, this is out of the hands of DS manufacturers and must be corrected by the drug product manufacturers and/or labelers (if different), which is more evident now based on the FDA notifications. If you are a DS manufacturer and received a notification requesting reporting on a finished drug product NDC, we suggest that you send an email detailing your specific situation to DrugAmountReporting@fda.hhs.gov for CDER-regulated products or to ocod@fda.hhs.gov for CBER-regulated products as requested in the original email (word on the street is that you may get agreement to disregard the original communication).
Additional “errors” discovered through these email notifications were old or outdated listings that were not properly inactivated. Some companies presumably thought that they had inactivated or superseded older listings with new NDCs, but they were included in the November email lists as they were still present in the FDA’s database. The hope is that correct registration and drug listing submissions will lessen these issues in the future, and future email notifications will address legitimate omissions by firms that had not submitted their CY 2023 CARES Act reports.
Finally, there appears to be some confusion between application holders, labelers, and manufacturers as to who is doing the reporting. The legal requirement to register and list is the responsibility of the manufacturer and, therefore, the requirement to submit CARES Act reports is also placed on manufacturers. However, reporting can be done by the application holder if this responsibility has been clearly delineated in the quality agreement. If your quality agreements do not specify who is responsible for CARES Act reporting, Lachman suggests that you modify them to include this responsibility so your reports are submitted and not duplicated or omitted.
Hopefully industry’s understanding of CARES Act reporting is improving and the FDA’s communication efforts will continue to get this reporting to a point where meaningful information can be found from it. If you have any questions regarding CARES Act reporting or drug listings, or need assistance with either, please contact Lachman at LCS@LachmanConsultants.com for a free consultation.
