InsideHealthPolicy.com's Daily Briefing - Powered by Dow Jones· US|February 13, 2024·07:34pm FDA drug officials hope their new final guidance asking manufacturers to report the amounts of drugs they manufactured will give more insight into the drug supply chain and help the agency take action to avoid shortages. The guidance implements requirements of the 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) requiring industry report the amount of all drugs “prepared, propagated, compounded, or processed for commercial distribution.”
Jacqueline Corrigan-Curay, principal deputy center director in FDA’s Center for Drug Evaluation and Research (CDER), told Inside Health Policy last week CDER expects the guidance to increase compliance with reporting requirements and help FDA take actions to prevent shortages. FDA officials have repeatedly urged manufacturers to share more information with the agency to help it avert drug shortages before they happen.
“There’s been reporting, but it hasn’t been as robust as it needs to be,” Corrigan-Curay said.
The final guidance, published Feb. 5, is an update of draft guidance from 2021. The final version includes new recommendations on how to report drug products in finished package form, drug products not in finished package form, and active pharmaceutical ingredients; clarifies reporting requirements for contract manufacturers; and clarifies how FDA plans to use data from the program.
“The data FDA receives will support the agency’s efforts to reduce drug shortage risks by providing the agency with a more comprehensive picture of the drug supply chain,” the agency wrote. “With earlier awareness of persistent or emerging supply chain challenges, FDA is better informed and able to take more targeted and timely actions to promote stronger supply chains and reduce drug shortage risks.” READ MORE
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