Navigating Shortages During the COVID-19 Pandemic
As the biopharmaceutical industry continues to research and develop innovative solutions to help combat the COVID-19 pandemic, the FDA and biopharmaceutical companies are working together to ensure continuity in the medicine supply chain. The FDA has proactively worked with manufacturers to prevent and mitigate any potential disruptions due to COVID-19, including expediting the review of a new supplier or manufacturing site as needed to avert shortages.
The Coronavirus Aid, Relief, and Economic Security (CARES) Act, which was signed into law in March 2020, granted the FDA additional authority to address drug shortages. Among other provisions, manufacturers of life-saving medicines, their active pharmaceutical ingredients, and any associated medical device included with a medicine for its preparation or administration are now required to develop a redundancy risk management plan identifying and evaluating risks to the supply of the drug for each establishment in which the drug or active pharmaceutical ingredient is manufactured.
Moreover, the Center for Drug Evaluation and Research has since required biopharmaceutical manufacturers to complete ongoing evaluations of their entire supply chains, including active pharmaceutical ingredients and finished dosage forms.