TUESDAY, July 17, 2018 — In a recent statement, U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D., announced the formation of a new drug shortages task force to thoroughly explore the reasons why drug shortages remain a persistent challenge.

The task force will be chaired by Keagan Lenihan, the FDA’s associate commissioner for strategic initiatives, and will include representatives from the Centers for Medicare & Medicaid Services and the Department of Veterans Affairs. The aim of the task force is to continue to advance the agency’s efforts to address shortages which were established under the FDA Safety and Innovation Act of 2012.

Two specific areas the task force is tasked with looking at include low-profit margin generic medicines and under-investment in drug manufacturing facilities. Furthermore, the task force and its work groups will conduct an examination of the FDA’s current authorities and consider how additional authorities from Congress might help better address shortages. Other issues the task force will consider are the development of a critical drugs list and the combination of regulations and financial incentives to encourage marketing of these critical access drugs.

“We are committed to working with manufacturers to resolve quality or manufacturing problems in a sustainable way that will help ensure continued patient access to vital safe and effective drugs,” Gottlieb said.

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Posted: July 2018

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