By Arif Noorani, Christopher Fanelli, David Ludlow, and Raj Pai; Sidley Austin LLP
With the remaining COVID-19 travel restrictions slowly being lifted, we are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We expect this trend to continue into 2023 and beyond as FDA and global health authorities work to reduce the backlog of overdue inspections while also staying current on new inspection assignments. This increased inspectional activity has already led to significant compliance and enforcement activity. Meanwhile, there has been a notable and recent increase in whistleblower complaints, prompted by the COVID-19 pandemic.
FDA has now resumed inspections to pre-pandemic levels domestically and is quickly getting up to speed internationally as well. Recent changes to the Federal Food, Drug, and Cosmetic Act (the FDCA) mean that many of FDA’s foreign inspections will be unannounced, especially in India, China, and other countries that are not covered by a mutual recognition agreement (MRA) with FDA.
Unannounced inspections abroad add a layer of complexity to inspection readiness, as most foreign manufacturers have historically had weeks or even months to prepare for an announced FDA inspection. Companies whose pharmaceutical supply chains are reliant on manufacturing sites located abroad, especially in India or China, should take steps to assess these sites’ GMP compliance and...
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