Regulatory Open Forum

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020, to aid response efforts and ease the economic impact of COVID-19. Included in law was a requirement for manufacturers to report quantities of products distributed during a calendar year. FDA issued a guidance providing "deadlines" for submitting the information thru the CDER NextGen Portal. The industry raised a ruckus and FDA issued a statement related to the February 2022 deadline for reporting 2020 records indicating that it was not a "requirement". I have not seen an update to the information since then.

How are other manufacturers dealing with this "request" from FDA. All in all it seems like a pretty typical process where Congress tells FDA to do something that they are not really prepared to do and then don't give the industry enough time and notice for them to comply.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Just a few days ago (Google says 3 days ago or May 3, despite the FDA March date), FDA posted:

03/21/22 - FDA announced updates to the CDER NextGen Portal CARES Act Amount Information Reporting process. These updates include:

• A new process to submit a CSV file, which will address limitations on the number of records in a CSV file and also address common file/validation errors
• A new process to replace existing submissions
• A new capability to view previously submitted reports

------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Senior Counsel, Wilson Sonsini

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and as a RAPS Fellow.
This is not intended as legal advice. Consult a lawyer for your specific matter.

Maryland
United States
------------------------------

Original Message:
Sent: 04-May-2022 08:53
From: Glen Park
Subject: CARES Act Amount Information Reporting

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020, to aid response efforts and ease the economic impact of COVID-19. Included in law was a requirement for manufacturers to report quantities of products distributed during a calendar year. FDA issued a guidance providing "deadlines" for submitting the information thru the CDER NextGen Portal. The industry raised a ruckus and FDA issued a statement related to the February 2022 deadline for reporting 2020 records indicating that it was not a "requirement". I have not seen an update to the information since then.

How are other manufacturers dealing with this "request" from FDA. All in all it seems like a pretty typical process where Congress tells FDA to do something that they are not really prepared to do and then don't give the industry enough time and notice for them to comply.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Hi Glen,
We still reported our 2020 records even though the FDA released the statement indicating that it was not a "requirement". We had already gathered all the information and had it ready for submission so we decided to still report. We have not seen an update to the information since the FDA statement either.
Original Message:
Sent: 04-May-2022 08:53
From: Glen Park
Subject: CARES Act Amount Information Reporting

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020, to aid response efforts and ease the economic impact of COVID-19. Included in law was a requirement for manufacturers to report quantities of products distributed during a calendar year. FDA issued a guidance providing "deadlines" for submitting the information thru the CDER NextGen Portal. The industry raised a ruckus and FDA issued a statement related to the February 2022 deadline for reporting 2020 records indicating that it was not a "requirement". I have not seen an update to the information since then.

How are other manufacturers dealing with this "request" from FDA. All in all it seems like a pretty typical process where Congress tells FDA to do something that they are not really prepared to do and then don't give the industry enough time and notice for them to comply.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------