The drug industry is raising concerns about the timeframe of the U.S. Food and Drug Administration’s (FDA) new drug reporting requirements. The requirements, created as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), call for FDA-registered drug establishments to submit annual reports to FDA of the amount of each listed drug that the company manufactured, prepared, propagated, compounded, or processed for commercial distribution. FDA wants companies to submit calendar year (CY) 2020 reports by February 15, 2022, and CY 2021 reports by May 16, 2022.

Drug companies submitted public comments in response to FDA’s guidance detailing these requirements. Many companies are concerned that they can not gather the required information by the February 15 deadline. These establishments are asking FDA to extend the deadline, allowing companies more time to work out the logistical challenges of gathering and preparing the required information.

What are the drug industry’s thoughts about FDA’s drug reporting requirements? Read on to get the specifics.

Not Enough Time

In its comments, generic drug company Viatris noted the complex nature of the information to be included in the CARES Act reports. Because all reports must correspond to a National Drug Code (NDC) number, large companies with an extensive inventory containing multiple NDC numbers per product will need to submit a substantial number of reports.

Viatris stated that, to supply the information requested, the industry would need to “compile, format, and submit over 3.3 million data points to the Agency in less than four months after issuance of the draft guidance.”

Along with other companies, Viatris is asking FDA to consider extending the February 15 deadline. Although establishments have suggested varying dates, most have proposed the deadline to submit CY 2020 reports be moved to April 2022 or later.

Not Enough Staff

Commenting parties also explained their current staff can not feasibly adopt the additional workload necessary to submit the detailed CARES Act reporting. Because companies did not already have people and processes in place to meet the requirement, many are not likely to currently have staff to devote to the complex reporting. Some establishments will need to collect that data from multiple facilities scattered across the globe.

Association for Accessible Medicine (AAM) commented that fulfilling the reporting requirements could take “14 full-time employees working on the reporting project full-time for a seven week period”, estimating that this additional staffing could cost the company up to $100,000. AAM also noted that, in addition to increased staffing, some establishments will need to invest in new or updated software, as compliance with these requirements “is not an instantaneous process that can be readily achieved based on existing systems and processes”.