FDA says volume manufacturing deadline is not a requirement after drugmakers lash out
Back in October, the FDA released a controversial draft guidance explaining to drug manufacturers how, beginning on Feb. 15, 2022, the FDA would start collecting annual manufacturing reports.
It would start with 2020 manufacturing data, including the volume or amount of each drug, and the same for active pharmaceutical ingredients.
The reports were created as part of the CARES Act, enacted in May 2020, which aided the Covid-19 response funding and added new provisions, like this one, meant to address pandemic-exacerbated drug shortages, by improving FDA’s visibility into drug/API supply chains.
Drugmakers almost uniformly called for a delay in the timelines of these volume reports, noting they would need more time to set up systems to track this requested info and noting that earlier years’ data might misleadingly suggest shortages that no longer exist.
Industry group BIO inquired into how the FDA might use this new data, and how it will enforce the reporting requirement, and which penalties, if any, would be imposed on establishments that do not report on the quantity of a drug intended for commercial distribution.
“With over 275,000 finished and unfinished drug package NDCs, according to FDA’s NDC directory, the Agency is asking industry 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compile, format, and submit over 3.3 million data points to the Agency in less than four months after issuance of the draft guidance,” generic drugmaker Viatris said in its comment.
Pfizer also raised concerns with FDA that the guidance issued may create problems for companies that have confidentiality agreements with their contract manufacturers.
“Providing reports as required under section 510(j)(3) could be considered a breach of these agreements and may be impactful to the CMO business,” Pfizer wrote.
While the draft guidance said that reports for 2020 should be submitted by this past Tuesday, and that reports for 2021 should be submitted by mid-May, the agency now says those aren’t hard deadlines.
In a rare note, released the day before the first deadline, the FDA signaled that it heard industry’s questions loud and clear, and that this first Feb. 15 deadline is not actually a requirement. FDA explains:
FDA is considering comments to our draft guidance on Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, including comments about the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.