On July 12, 2018, the US Food and Drug Administration (FDA) announced the creation of a new drug shortages task force, led by Keagan Lenihan as well as leaders from the Centers for Medicare and Medicaid Services (CMS). Kaegan is the FDA’s associate commissioner for strategic initiatives. Despite a steadily decreasing number of new drug shortages since a peak in 2011, ongoing shortages of medically necessary products continue.
In FDA Commissioner Scott Gottliebs’ statement, he acknowledges that FDA has not fully identified the underlying concerns that give rise to the shortages. Therefore, the new Drug Shortages Task Force will “delve more deeply into the reasons why some shortages remain a persistent challenge” and “look for holistic solutions to addressing the underlying causes for these shortages.”1
The task force is an expansion upon the work of a group that was created by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA). Gottlieb says, “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. I also want the task force to explore possible incentives to encourage expansion of manufacturing capacity and enhanced quality.”1
FDA intents to engage the public and hold a meeting with stakeholders in the next several months to provide everyone the opportunity with a stake in addressing drug shortages to come to the table.
In early July, FDA announced a rise in drug shortages that ranged from Mylan’s EpiPen to mundane IV fluids. To learn more about the recent rise in drug shortages visit our latest blog.