FDA addresses CARES Act efforts

Jan. 7, 2021

In addition to the COVID-19 response efforts, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) includes authorities intended to enhance the U.S. Food and Drug Administration’s (FDA’s) ability to identify, prevent, and mitigate possible drug shortages by, among other things, enhancing the FDA’s visibility into drug supply chains, stated the agency.

Drug shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Drug manufacturers provide the FDA with most of the drug shortage information the agency receives, and the agency works closely with them to prevent or reduce the impact of shortages.

The specific authorities to enhance the FDA’s ability to identify, prevent, and mitigate drug shortages include:

· CDER’s Implementation of New FDA Authority under the CARES Act

· Notifying the FDA of Manufacturing Discontinuance and Interruptions

· Creating Risk Management Plans for Drugs

· Reporting the Amount of Drugs Manufactured

· Notifying the FDA of Manufacturing Discontinuances and Interruptions

The CARES Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act to expand the requirement for manufacturers of certain drugs to provide information on permanent discontinuances and interruptions in manufacturing that may lead to a meaningful disruption in supply to the FDA.

The FDA plans to issue guidance on reporting these manufacturing discontinuances and interruptions to the FDA.

The CARES Act amended the FD&C Act to include a provision requiring manufacturers of drugs 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.

The FDA plans to issue guidance on risk management plans.

The CARES Act amended the FD&C Act to require drug manufacturers registered under section 510 of the FD&C Act to annually report on the amount of each drug that they "manufactured, prepared, propagated, compounded, or processed” for commercial distribution.

The effective date of this reporting requirement was September 23, 2020 (180 days after the CARES Act was enacted), which represented the earliest the FDA was authorized to begin collecting these data. The FDA has not yet begun collecting these data and does not intend to begin this collection until it is able to do so through an electronic data submission portal. The FDA is still determining the best way to receive these data and will notify drug manufacturers when such an electronic system is in place.

FDA has the notice

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