It’s that time of year.  Taxes?  Well, yes, but that’s not what I’m talking about.  Instead, I’m referencing the equivalent for those of us in the pharmaceutical industry—CARES Act reporting.  In the last couple of weeks, a flurry of emails arrived for many of us from the FDA, reminding us that:

“Under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), each drug registrant is required to report annually to FDA on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.”

The email continues with the following language:

“With respect to calendar year 2022 data, FDA suggests that registrants submit reports as described in the draft guidance, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.  The draft guidance document recommends that reports for 2022 data be submitted by February 15, 2023.”

So, you may be asking, is CARES Act reporting actually required?  Yes, but the date of February 15th is a recommendation (per FDA guidance).  The FDA’s CARES Act webpage states, in a red box at the top:

“FDA is considering comments to our draft guidance on Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic [FD&C] Act, including comments about the recommended timeframes for submitting the required reports. The draft guidance document is not a binding document and its recommended reporting dates are not required deadlines for submitting such data.  However, registrants are still required under section 510(j)(3) of the FD&C Act to report annually regarding the amount of listed drugs that are manufactured, prepared, propagated, compounded, or processed for commercial distribution.  With respect to calendar year 2022 data, FDA suggests that registrants submit reports as described in the draft guidance, which recommends that reports for 2022 data be submitted by February 15, 2023. 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 We will consider updating the draft guidance’s recommended timeframes for reporting, as appropriate, along with other issues raised by such stakeholder feedback.”

Lachman Consulting Services, Inc. (Lachman) does recommend complying with the FDA’s request to do this reporting through the portal as close to this date as possible.  There were some updates made to CARES Act information reporting since our last blog on the topic (here) in February 2022.  These updates include:

  • A new process for submitting the CSV files that addresses some of the issues of the previous version, including limitations on the number of records and common file or validation errors
  • A new process wherein you can replace existing submissions
  • A new capability for viewing previously submitted reports

Also on the FDA webpage is a link to an updated webinar that will walk the viewer through using the NextGen Portal and through the process of reporting through CARES Act reporting in the system.  It also has a link to the CSV template (updated) and CSV instructions (also updated).  These are all helpful tools, along with the information we presented in the aforementioned blog post, which gives some handy tips to help you figure out why your report may be getting rejected!

In May 2022, a new guidance titled “Risk Management Plans to Mitigate the Potential for Drug Shortages” was issued.  It addresses the CARES Act amendment to the FD&C Act in 2022, which added section 506C(j) and requires certain manufactures to develop, maintain, and implement, as appropriate, a “redundancy risk management plan that identifies and evaluates risks to the supply of the drug, as applicable, for each establishment in which such drug or active pharmaceutical ingredient of such drug is manufactured.”  Risk Management Plans (RMPs) are to be developed for APIs, drug products, and devices in the following categories:

  • Drug products that are:
    • Life-supporting
    • Life-sustaining
    • Intended for use in the prevention or treatment of a debilitating disease or condition or would be considered critical in a public health emergency
  • Any API that would be used in the products listed above
  • Any associated medical device used for preparation or administration of the drug products listed above

In addition, though not required under section 506C(j), the FDA recommends that stakeholders of certain types of products also develop, maintain, and implement RMPs for the following product types:

  • Drug products that treat rare diseases or conditions
  • Drug products that lack appropriate alternatives
  • Medical countermeasures that would be used in the event of a potential public health emergency stemming from a terrorist attack with a biological, chemical, or radiological/nuclear material, or naturally occurring emerging disease, or other threatening agents
  • Sole-sourced products (per the guidance, this is defined as a drug product of a specific strength, dosage form, or route of administration manufactured by only one entity for sale in the U.S.)
  • Drug products and APIs with only one qualified source/manufacturer
  • Drug products produced in a single qualified facility with an inspectional status of Official Action Indicated (OAI) within the last five years

The guidance recommends using the framework outlined in ICH Q9 for your RMP, but also provides an outline in the guidance.

If you have any questions regarding CARES Act reporting or need assistance doing so, please contact r.welton@lachmanconsultants.com.  Happy reporting!