The other session that I was able to monitor was the Cares Act – Additional Reporting Requirements for Manufacturers. The purpose of the new reporting requirements is to proactively identify potential drug or API shortages so that the FDA can begin to act and perhaps institute a flexible regulation approach to mitigate the shortage. The elements of potential drug shortage that are important were presented to include:
- Notification of permanent discontinuance or interruption in manufacturing that is likely to lead to a meaningful disruption in supply.
- Early notification including specific information about the situation that will allow the Agency to evaluate and take appropriate action.
- Early, informative notifications are the best tool the Agency has to mitigate the impact of an unavoidable shortage.
The FDA presenter indicated that “these early notifications helped avert 199 drug shortages in 2020”.
The CARES Act of 2020 requires the applicant to report certain drug and API data to the FDA through the Nextgen portal. The FDA has issued specific guidance here and here to describe how and who must list. The FDA presenters ran through a brief summary of the requirements in terms of who, what, and when the information is to be reported. See bullets below:
For the “Who” need to report and “When”-
- All establishments registered with FDA under Section 510 of the FD&C Act.
- To simplify reporting, FDA has limited reporting for each NDC to the following business operations:
- API manufacturer
- Repacker, relabeler
- Positron Emission Tomography producers
- Reports for calendar year 2020 should be submitted no later than February 15, 2022, and reports for 2021 should be submitted no later than May 16, 2022
Timelines are short and there is a lot of data to be collected and submitted, so start your clock now and be ready for the deadlines.
As for What types of drugs to report –
- RX/OTC (OTC application OTCs and those OTC products with or without a monograph)
- Homeopathic drug products
- Medical gas drug products
There are certain blood and cell and gene product excluded so be sure to read the guidance documents.
What influenced or exacerbated the supply chain problems leading to shortages during the pandemic? The pandemic created a hyper-increase in demand and panic buying for just about everything, from toilet paper to drugs to cars. People feared running out of their prescription medication so they started ordering a 3-month prescription refill so they would not run out or need to go out especially under lockdowns. There was so much demand for things like PPE, hand sanitizers, hand wipes that flew off the shelf as soon as they were stocked, or they were not longer in stores for extended periods of time. As the cases of COVID surged, manufacturers were forced to cut supply or close altogether as they had a shortage of workers, or the materials needed to make the products. We are all feeling the impact of the shortages and supply chain issues even today.
The industry and FDA presenters not only provided a united front in discussing these issues, but most talks overlapped in content because both were speaking with one voice. How rare is that the industry and the Agency are than closely aligned on thinking?
We will try to get you some more information tomorrow when the technical sessions begin but there is still time to take advantage of the meeting, I am sure. Contact AAM directly!