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Analysis

FDA Forms Task Force to Solve Drug Shortages

By John Commins  
   July 12, 2018

Federal officials to consider enhanced regulation and notifications from pharmaceutical companies, coupled with 'financial incentives' to ensure continued access to critically needed drugs.

Food & Drug Administration Commissioner Scott Gottlieb has formed a task force to address the nation's ongoing drug shortages.

"I'm charging the shortages task force to delve more deeply into the reasons why some shortages remain a persistent challenge," Gottlieb said Thursday in prepared remarks. "The charge to this new task force is to look for holistic solutions to addressing the underlying causes for these shortages."

Related: 5 Strategies to Deal with ER Drug Shortages

The Drug Shortages Task Force will be led by Keagan Lenihan, the FDA's associate commissioner for strategic initiatives, and it will include senior officials from the FDA, the Centers for Medicare & Medicaid Services, and the Department of Veterans Affairs, Gottlieb said.

The taskforce will break into workgroups focusing on specific factors leading to the drug shortages, which will include a review of FDA's current authority over drug shortages, and reimbursement policies from CMS and other payers, Gottlieb said.

"One possibility might be to look at regulations coupled with additional financial incentives to market these critical access drugs," he said. "We want to make sure we aren't discouraging investment for manufacturing drugs that are more likely to go into shortage, and thus working against our own goals."

Gottlieb said those incentives could be coupled with requirements for sharing critical information from the pharmaceutical industry when they notify FDA about shortages.

"We'll be looking at whether it makes sense to develop a critical drugs list, or a list of essential drugs," he said. "These are medicines where it would be especially important, from a clinical perspective, to ensure an uninterrupted drug supply. For these medicines, we may want to consider more significant interventions than we currently employ to avert shortages."

In June, the American Medical Association declared the drug shortages an "urgent public health crisis," and urged the federal government to review the issue as national security initiative.

A recent survey found that 91% of emergency medicine physicians had recently experienced a drug shortage.   

Jim Augustine, MD, a board member at the American College of Emergency Physicians, said the shortages "affect almost all types of drugs used every single day in the ED—local anesthetics, injectable pain medications used for broken bones or trauma, common anti-nausea medications, heart medications, and even IV fluids used to deliver life-saving treatments."

Blair Childs, senior vice president of public affairs at Premier, welcomed the creation of the taskforce, and said it comes as 96% of hospitals in his network report that drugs shortages are a top priority.

"Drug shortages have serious implications for essential patient care, and simultaneously lead to higher prices for drugs at a time when provider margins are at an all-time low," he said. "We applaud the FDA for taking proactive action and for considering market incentives as a way to drive continued production of critical drugs."

John Commins is a senior editor at HealthLeaders.

Photo credit: (at top) FDA Commissioner Scott Gottlieb, MD, on May 12, 2017. (Photo by Food & Drug Administration)


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