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Gottlieb, Woodcock Highlight FDA’s Efforts to Tackle Drug Shortages

Posted 19 November 2018 | By Michael Mezher 

Gottlieb, Woodcock Highlight FDA’s Efforts to Tackle Drug Shortages

The US Food and Drug Administration (FDA) is working to update its approach to drug shortages in the wake of Hurricane Maria in 2017 and other high profile manufacturing-related shortages that occurred over the last year.
In a blog post Monday, FDA Commissioner Scott Gottlieb and Center for Drug Evaluation and Research Director Janet Woodcock described some of the challenges facing the agency and its plans for addressing those challenges ahead of a public meeting on the topic later this month.
“Ensuring that a necessary drug is available to a patient involves a lot of stakeholders working together at key stages of the development, manufacturing, marketing, and distribution of a medicine,” Gottlieb and Woodcock write.
According to the two FDA leaders, the agency helped avert 132 potential drug shortages in 2017 by prioritizing inspections of critical manufacturing facilities, expediting reviews of sole-source and priority generics and temporarily allowing imports of certain foreign drugs.
While the number of drug shortages is down relative to 2011 when it saw a record 251 shortages, Gottlieb and Woodcock say that investment in new technologies such as 3D printing and continuous manufacturing and expanding collaboration with stakeholders will be key to preventing and addressing drug shortages in the future.
“Over time, these methods could lower drug production costs, enable more rapid scale up of manufacturing, and help prevent drug shortages caused by product quality and manufacturing problems,” Gottlieb and Woodcock write.
With those issues in mind, the two say that FDA’s recently launched Drug Shortages Task Force will play a critical role by engaging with stakeholders to develop potential solutions going forward.
“The work of the task force will be forward-leaning and extensive, including ongoing engagement with stakeholders to consider possible proposals for additions to the FDA’s authorities, evaluate reimbursement policies of payors, explore possible incentives to encourage manufacturing that can expand and ensure a stable drug supply, and evaluate the need for an essential drugs list and incentives for manufacturing critical drugs,” Gottlieb and Woodcock write.

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