Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts

02/26/2024 - Registrants of drug establishments (or their authorized agents) who have not submitted their calendar year 2023 report of the amount listed drug and biological products can now report through the updated CARES Act Amount Information Reporting application in the NextGen Portal. The recommended time frame for submitting 2023 calendar year reports is no later than July 31, 2024. Reports for subsequent years are recommended to be submitted no later than March 31 of the following calendar year.

The final guidance FDA issued on 02/05/2024 is now being implemented and FDA has issued revisions to the Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide to assist in reporting.

Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Background

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.

In addition to the COVID-19 response efforts, the CARES Act included authorities intended to enhance FDA’s ability to identify, prevent, and mitigate possible shortages of human and animal drugs by, among other things, enhancing FDA’s visibility into the drug and medical product supply chains. Drug shortages can occur for various reasons, including manufacturing and quality problems, delays, and discontinuations. Drug manufacturers provide FDA with most of the drug shortage information the agency receives, and the agency works closely with manufacturers to prevent or reduce the impact of shortages.

The specific authorities to enhance FDA’s ability to identify, prevent, and mitigate drug shortages are summarized below.

Implementation of New FDA Authorities added by the CARES Act

Notifying FDA of Permanent Discontinuances and Interruptions in Manufacturing

The CARES Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act to expand the requirement for manufacturers of certain drugs to notify FDA about permanent discontinuances in manufacturing or interruptions in manufacturing that are likely to lead to a meaningful disruption in supply in the United States, and the reasons for such discontinuances or interruptions.

FDA issued a draft guidance for industry titled, “Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients (API) Under Section 506C of the FD&C Act” to assist applicants and manufacturers in providing FDA with timely, informative notifications about changes in the production of certain finished drugs and biological products and certain APIs. Timely notifications that include detailed information allow the agency to evaluate the situation and determine an appropriate course of action to help prevent or mitigate drug shortages.

The CARES Act amended the FD&C Act to include a provision requiring each manufacturer of a drug described in section 506C(a) of the FD&C Act or of any active pharmaceutical ingredient (API) or any associated medical device used for preparation or administration included in the drug 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 the drug or API of the drug is manufactured.

FDA issued a draft guidance for industry titled, “Risk Management Plans to Mitigate the Potential for Drug Shortages” intended to help manufacturers develop, maintain, and implement, as appropriate, risk management plans to proactively assist in the prevention of human drug product and biological product shortages. This draft guidance is relevant to any person or entity who has oversight and control over the manufacture of drugs to ensure quality or owns or operates an establishment that manufactures a drug or biological product.

Creating Risk Management Plans for Drugs

The CARES Act amended the FD&C Act to include a provision requiring each manufacturer of a drug described in section 506C(a) of the FD&C Act or of any active pharmaceutical ingredient (API) or any associated medical device used for preparation or administration included in the drug 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 the drug or API of the drug is manufactured.

FDA issued a draft guidance for industry titled, “Risk Management Plans to Mitigate the Potential for Drug Shortages” intended to help manufacturers develop, maintain, and implement, as appropriate, risk management plans to proactively assist in the prevention of human drug product and biological product shortages. This draft guidance is relevant to any person or entity who has oversight and control over the manufacture of drugs to ensure quality or owns or operates an establishment that manufactures a drug or biological product.

Reporting the Amount of Listed Human and Animal Drugs and Human Biological Products Manufactured

The CARES Act amended the FD&C Act to require that each person (including repackers and relabelers) who registers with FDA under section 510 of the FD&C Act with regard to a human or animal drug must report annually to FDA the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.

Through the NextGen Portal, FDA has established a way through which drug registrants and their authorized agents should report the required data. There are guides and videos to provide instructions for how to use the portal. Further information about reporting can be found in the Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act Guidance for Industry and the Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide.

The reporting requirements apply to each person who registers with FDA under section 510 of the FD&C Act with regard to a listed drug (including a finished dosage form product, an active pharmaceutical ingredient (API), and other types of listed drugs, except for biological products or categories of biological products exempted by an order under section 510(j)(3)(B)). In addition to human drugs approved under section 505 of the FD&C Act, and animal drugs approved under section 512, conditionally approved under section 571 or indexed under section 572 of the FD&C Act, the process described in the guidance also applies to such reporting with respect to other listed drugs including medical gases, as defined in section 575 of the FD&C Act, drugs labeled as homeopathic, drugs marketed in accordance with requirements under section 505G of the FD&C Act, often referred to as Over-the-Counter Monograph drugs, and animal drugs that are not approved, conditionally approved, or indexed under sections 512, 571, and 572 of the FD&C Act.

NextGen Resources