Kristin Brooks, Managing Editor, Contract Pharma03.31.23
In 2022, the pharmaceutical industry saw the most units recalled than in the past six years, with 567.3 million, a 114% increase over the 264.6 million units recalled in 2021, according to new data from the recent Sedgwick 2023 State of the Nation Recall Index report.1
The report provides insight and analysis for mitigating recall risk along with key perspectives on past and present recall data and product safety trends. The index also shares insights and guidance into the economic, regulatory and legal developments shaping product safety in the pharmaceutical sector.
As supply chains become more diverse, and regulatory environments more complex, companies face increased liability, if proper measures are not taken. Chris Harvey, Senior Vice President, Sedgwick brand protection, discusses findings from the Recall Index report, including 2022 recall data, what it means for the pharmaceutical industry, and predictions for 2023. –KB
Contract Pharma: What do you anticipate the FDA’s top product safety priorities will be in 2023?
Chris Harvey: The Biden Administration released the Fall 2022 Unified Agenda of Regulatory and Deregulatory Actions in January 2023. The FDA listed 74 short-term actions and 13 long-term actions across all FDA-regulated product categories including drugs, biologics, dietary supplements, and tobacco products. We can expect the agency to continue its aggressive stance on tobacco products and closer monitoring of supplements in 2023.
We also anticipate guidance and further clarification on the new Food and Drug Omnibus Reform Act of 2022 (FDORA), the Modernization of Cosmetics Regulation Act of 2022 (MOCRA), and other changes that were included as part of the December 2022 omnibus appropriations bill.
CP: What types of pharmaceutical products are being recalled and what are these recalls attributed to?
CH: There were 11 categories for which pharmaceutical products were recalled in 2022 including Current Good Manufacturing Practice (cGMP) deviations, contamination, failed specifications, leakage, and sterility. These categories applied to both prescription and over-the-counter (OTC) drugs and health products.
Accounting 83 of the 363 events and 437.5 million units – 77.1% of all pharmaceutical units recalled for the year – cGMP deviations was the most common reason for recalls in this sector. Impacted products included OTC pain relievers, a variety of hand sanitizers, antibiotic ointment and several brands and strengths of losartan potassium tablets.
The FDA has the authority to waive some of the cGMP requirements for products that receive emergency use authorization (EUA), as many did during the COVID-19 public health emergency (PHE). As the PHE ends, there may be a further increase in cGMP violations. Smaller companies that started manufacturing products during the pandemic are less familiar with the strict requirements of cGMP. If they want to continue marketing products once the EUA period ends, they could face some tough challenges.
Sterility and failed specifications both accounted for 68 recalls each, making them the joint second reason for pharmaceutical recalls in 2022. Impacted products included sodium bicarbonate injections, magnesium citrate, eye drops, and allergy relief tablets. Despite both recording the same number of recall events, there were far more units recalled over sterility issues (96.1 million) than failed specifications (11.4 million).
CP: What are some key FDA reform changes can we expect to see?
CH: One area to watch is cannabidiol (CBD), an active ingredient in cannabis. Despite being used in everything from foods to topical products, the FDA denied three citizen petitions requesting rulemaking to allow CBD products to be marketed as dietary supplements. The FDA determined it is not clear how these products could meet current safety standards and that a new regulatory pathway for CBD products was needed.
The agency also issued final guidance for using cannabis and cannabis-derived compounds in clinical research, detailing standards and requirements for investigational new drug applications.
Another key area will be the FDA’s position on artificial intelligence (AI) in drug manufacturing. A discussion paper issued in March 2023 looked at possible applications and benefits. It also identified regulatory questions and asked for feedback in five areas such as the need for standards in developing and validating AI models used for process control and to support release testing.
CP: How might changes to the FDA’s authority under the new Omnibus Reform Act affect pharmaceutical companies and contract manufacturers?
CH: Pharmaceutical companies and contract manufacturers will be impacted by the FDA’s accelerated approval process for drugs and biologics. Under the Omnibus Reform Act, the FDA can require a post-approval study to be underway prior to granting accelerated approval for drugs and biologics. It also expands the agency’s current expedited withdrawal procedures and allows the use of accelerated procedures if a sponsor fails to conduct any required post-approval study of the product with due diligence. In fact, this failure, or the failure to submit timely reports for the product, would be considered prohibited acts under the Food, Drug & Cosmetics Act (FD&C Act).
Under the new accelerated approval provisions, sponsors must submit progress reports every 180 days for any post-approval study. These reports will be published on the FDA’s website. This transparency will create potential risk for sponsors if they fail to meet the schedule.
1. https://marketing.sedgwick.com/acton/media/4952/us-sotn-2023-index-report-download-pr
Chris Harvey is senior vice president of brand protection at Sedgwick. With 15 years’ experience, he is recognized as an expert in the recall industry and routinely speaks on best practices at trade shows, conventions, and conferences. Throughout his career, Chris has managed more than 1,200 recall and in-market remediations, including hundreds for the largest U.S. and global brands. He also serves on the board of directors of the International Consumer Product Health and Safety Organization (ICPHSO).
The report provides insight and analysis for mitigating recall risk along with key perspectives on past and present recall data and product safety trends. The index also shares insights and guidance into the economic, regulatory and legal developments shaping product safety in the pharmaceutical sector.
As supply chains become more diverse, and regulatory environments more complex, companies face increased liability, if proper measures are not taken. Chris Harvey, Senior Vice President, Sedgwick brand protection, discusses findings from the Recall Index report, including 2022 recall data, what it means for the pharmaceutical industry, and predictions for 2023. –KB
Contract Pharma: What do you anticipate the FDA’s top product safety priorities will be in 2023?
Chris Harvey: The Biden Administration released the Fall 2022 Unified Agenda of Regulatory and Deregulatory Actions in January 2023. The FDA listed 74 short-term actions and 13 long-term actions across all FDA-regulated product categories including drugs, biologics, dietary supplements, and tobacco products. We can expect the agency to continue its aggressive stance on tobacco products and closer monitoring of supplements in 2023.
We also anticipate guidance and further clarification on the new Food and Drug Omnibus Reform Act of 2022 (FDORA), the Modernization of Cosmetics Regulation Act of 2022 (MOCRA), and other changes that were included as part of the December 2022 omnibus appropriations bill.
CP: What types of pharmaceutical products are being recalled and what are these recalls attributed to?
CH: There were 11 categories for which pharmaceutical products were recalled in 2022 including Current Good Manufacturing Practice (cGMP) deviations, contamination, failed specifications, leakage, and sterility. These categories applied to both prescription and over-the-counter (OTC) drugs and health products.
Accounting 83 of the 363 events and 437.5 million units – 77.1% of all pharmaceutical units recalled for the year – cGMP deviations was the most common reason for recalls in this sector. Impacted products included OTC pain relievers, a variety of hand sanitizers, antibiotic ointment and several brands and strengths of losartan potassium tablets.
The FDA has the authority to waive some of the cGMP requirements for products that receive emergency use authorization (EUA), as many did during the COVID-19 public health emergency (PHE). As the PHE ends, there may be a further increase in cGMP violations. Smaller companies that started manufacturing products during the pandemic are less familiar with the strict requirements of cGMP. If they want to continue marketing products once the EUA period ends, they could face some tough challenges.
Sterility and failed specifications both accounted for 68 recalls each, making them the joint second reason for pharmaceutical recalls in 2022. Impacted products included sodium bicarbonate injections, magnesium citrate, eye drops, and allergy relief tablets. Despite both recording the same number of recall events, there were far more units recalled over sterility issues (96.1 million) than failed specifications (11.4 million).
CP: What are some key FDA reform changes can we expect to see?
CH: One area to watch is cannabidiol (CBD), an active ingredient in cannabis. Despite being used in everything from foods to topical products, the FDA denied three citizen petitions requesting rulemaking to allow CBD products to be marketed as dietary supplements. The FDA determined it is not clear how these products could meet current safety standards and that a new regulatory pathway for CBD products was needed.
The agency also issued final guidance for using cannabis and cannabis-derived compounds in clinical research, detailing standards and requirements for investigational new drug applications.
Another key area will be the FDA’s position on artificial intelligence (AI) in drug manufacturing. A discussion paper issued in March 2023 looked at possible applications and benefits. It also identified regulatory questions and asked for feedback in five areas such as the need for standards in developing and validating AI models used for process control and to support release testing.
CP: How might changes to the FDA’s authority under the new Omnibus Reform Act affect pharmaceutical companies and contract manufacturers?
CH: Pharmaceutical companies and contract manufacturers will be impacted by the FDA’s accelerated approval process for drugs and biologics. Under the Omnibus Reform Act, the FDA can require a post-approval study to be underway prior to granting accelerated approval for drugs and biologics. It also expands the agency’s current expedited withdrawal procedures and allows the use of accelerated procedures if a sponsor fails to conduct any required post-approval study of the product with due diligence. In fact, this failure, or the failure to submit timely reports for the product, would be considered prohibited acts under the Food, Drug & Cosmetics Act (FD&C Act).
Under the new accelerated approval provisions, sponsors must submit progress reports every 180 days for any post-approval study. These reports will be published on the FDA’s website. This transparency will create potential risk for sponsors if they fail to meet the schedule.
1. https://marketing.sedgwick.com/acton/media/4952/us-sotn-2023-index-report-download-pr
