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Drug Shortage Reporting Rules Prompt Questions as Deadlines Loom

Nov. 10, 2021, 9:07 PM

The meaning of a “life-saving” drug and how quickly supply chain data can become available are among the questions pharmaceutical companies are raising as they work to comply with expanded reporting rules aimed at combating pandemic-fueled shortages.

The goal of the updated rules is to bring efficiency to drug shortage reporting so that the Food and Drug Administration can be better equipped to handle public health crises in the future. But concerns remain that the scope of the requirements, along with the timelines for meeting them, are becoming too arduous a task for drugmakers that are already working to meet the heightened demand for certain medications and supplies during the pandemic.

Companies must now report to the FDA the annual amount of each listed drug manufactured for commercial distribution. They also must report shortages of any active pharmaceutical ingredient (API) for covered drugs, as well as details on the potential cause, expected duration, and potential impacts. That’s on top of a pre-pandemic requirement that they notify the FDA of any interruption to the manufacture of a finished product.

Drugs subject to shortage reporting requirements include any life-saving drug “that is critical to the public health during a public health emergency declared by” the health and human services secretary, according to the coronavirus relief measure that expanded the requirements.

That could create “a huge endeavor for industry to comply with,” given the large volume of prescription drugs in the U.S. marketplace, said Sandra D’Agostino-Ferlisi, director of global regulatory intelligence and policy at pharmaceutical company Apotex Inc.

“One could argue that the majority of prescription drugs may fall into this definition,” she said this week at the Association for Accessible Medicine’s Generics and Biosimilars Conference.

Congress expanded the reporting requirements through the Coronavirus Aid, Relief, and Economic Security, or CARES, Act, which was signed into law in March 2020 as part of the government’s efforts to address the pandemic’s economic impacts.

FDA officials this week sought to clarify industry questions, but cautioned that it will take a period of coordination and additional conversations before an efficient system of reporting drug shortages is realized.

“The sooner that we know there’s an issue or supply gap, the better off we are at trying to be able to mitigate the situation,” Capt. Christine Bina, a team leader on the FDA Center for Drug Evaluation and Research’s drug shortage staff, said at the conference. Bina added that in 2020 alone, notifications helped avert 199 drug shortages.

CARES Act Changes

The annual volume and drug shortage reporting changes took effect 180 days after the CARES Act became law. As the FDA continues to implement the expanded requirements, manufacturers are citing challenges in gathering the necessary information in time to meet reporting deadlines.

The first batch of product volume reports from the 2020 calendar year must be submitted to the FDA’s NextGen Portal by Feb. 15, 2022, while reports from 2021 must be uploaded no later than May 16, 2022.

Manufacturers must notify the FDA of a drug or API shortage at least six months prior to the date of the permanent discontinuance or interruption. If a drugmaker isn’t able to provide advance notice, it must submit a report no later than five business days after the production end or pause.

Industry representatives lauded the FDA’s work to increase transparency on drug shortages, but said logistical questions remain on how to meet the reporting requirements, as well as how the FDA will use the volume of data to track industry shortages.

“When you look at the supply chain of an organization, it can become, or be, a very complicated web,” D’Agostino-Ferlisi said. She added it will take time for manufacturers to work with their suppliers to put together both the annual volume data and information on drug and API shortages.

With regard to the shortage reporting requirements, additional guidance is needed to clarify which treatments meet the definition of life-saving drug, D’Agostino-Ferlisi said. She also pointed out that details on the origins and impact of a potential shortage may not be “readily available to the applicant in a timely manner,” thus leading to potential delays in reporting.

Veda Walcott, vice president of global regulatory affairs and compliance at Catalent Pharma Solutions, expressed similar concerns over the deadlines for reporting supply pauses to the FDA.

“The tight timelines for reporting does cause some concern for the hundreds of products in which we will need to submit data, as it does take some time to update contractual agreements,” with suppliers, she said.

Walcott called for flexibility when reporting the possible impact of a disruption or discontinuance “when we don’t have clarity of the intended market or if the product is intended for clinical or commercial supply.”

‘Learning Process’

The FDA is expected to receive an influx of data on Feb. 15, but Ashley Boam, director of the Office of Policy for Pharmaceutical Quality, said the agency will be well-prepared to “immediately jump into looking at the data and seeing what’s in there to make comparisons,” and identify potential disruptions in pharmaceutical supply chains.

FDA officials worked to clarify other aspects of the reporting requirements for industry members, including which actor would be required to report a shortage.

The reporting requirements under the CARES Act falls solely to the manufacturer of a specific drug or component experiencing a disruption, and not the sponsor of a particular drug application submitted to the FDA, Obinna Ugwu-Oju, divison director of CDER’s surveillance office within the Office of Pharmaceutical Quality, said.

D’Agostino-Ferlisi told Bloomberg Law that Apotex, the largest Canadian manufacturer of generic drugs, is “encouraged by the agency’s guidance on this topic” and looks forward to “working with the FDA as a we implement the reporting requirements.”

The agency released draft guidance in October to help registrants with the new requirements for reporting the annual volume of covered drugs manufactured, and is accepting public comments on the proposed document until Dec. 29.

In the coming months, the FDA plans to release additional guidance on notifying the FDA of a discontinuance or disruption in line with the CARES Act. Other guidance is also forthcoming on how a manufacturer of a specific drug, active pharmaceutical ingredient, or medical device can develop a risk management plan to evaluate the impacts of shortages on supply chains.

Even with the efforts to clarify agency guidance, Boam said the “first year of reporting is going to be a learning process for all of us.”

“Industry will help us recognize where maybe there’s some pieces where we need to provide additional guidance or where we need to clarify, or maybe there’s some unintended pieces that we didn’t think about,” Boam said. “Our goals are really to learn, so that we put the agency in a position to have the most accurate data possible going forward.”

To contact the reporter on this story: Celine Castronuovo at

To contact the editor responsible for this story: Alexis Kramer at