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FDA to Form New Drug Shortages Task Force

Posted 12 July 2018 | By Zachary Brennan 

FDA to Form New Drug Shortages Task Force

As the number of new drug shortages has steadily declined since 2011, the US Food and Drug Administration (FDA) on Thursday announced the creation of a new drug shortages task force, led by Keagan Lenihan, the FDA’s associate commissioner for strategic initiatives, and including leaders from the Centers for Medicare and Medicaid Services (CMS) and the Department of Veterans Affairs. 

The task force will delve into why certain shortages remain a challenge for long periods of time – ideas Focus explored last week – particularly as some shortages are tied to sterile, parenteral drugs, which can be challenging and expensive to manufacture.

“The task force will expand upon the work of a group that was created by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA),” FDA Commissioner Scott Gottlieb said in a statement. “As we stand up the task force, we intend to establish several dedicated workgroups to look at various aspects of this issue. These will include an examination of the FDA’s current authorities. It will also evaluate the reimbursement policies from CMS and other payors that could be making it difficult for companies to manufacture certain drugs profitably.”

Gottlieb also said he wants the task force to explore possible incentives for encouraging the expansion of manufacturing capacity.

“We’ll be looking at whether it makes sense to develop a critical drugs list, or a list of essential drugs,” he added.  
 

Categories: Regulatory News

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