The US Food and Drug Administration (FDA) has formed a new Drug Shortages Task Force that will be led by Keagan Lenihan, the FDA’s Associate Commissioner for Strategic Initiatives. The task force is being charged to delve into why some drug shortages remain a persistent challenge and to look for solutions to addressing the underlying causes for these shortages.

“Lawmakers have recently urged us to develop new proposals for the actions that we believe could have a more enduring impact on solving these vulnerabilities,” FDA Commissioner Scott Gottlieb said in a July 12, 2018 agency statement. “In that spirit, they’ve asked us to consider whether the FDA or other federal agencies may need additional authorities to help ensure that patients have continued access to their medicine. They have also asked us for recommendations on the policy steps we can implement to address the root causes that give rise to shortages. We are taking up this cause.”

The task force will include senior leaders from the FDA, the Centers for Medicare and Medicaid Services (CMS), and the Department of Veterans Affairs.

“As we stand up the task force, we intend to establish several dedicated workgroups to look at various aspects of this issue,” Gottlieb said in his statement. “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. We’ll be looking at whether it makes sense to develop a critical drugs list, or a list of essential drugs. These are medicines where it would be especially important, from a clinical perspective, to ensure an uninterrupted drug supply.”

Gottlieb also offered an option to expand the FDA’s authority to require applicants of certain drugs to conduct a risk assessment to identify the vulnerabilities in their drug supply that could cause a shortage and to establish risk-mitigation plans to address those weaknesses proactively. Gottlieb says the task force will also be exploring manufacturing issues. The FDA said it is taking steps to support new technologies that can improve manufacturing and help reduce the chance that supply disruptions will occur.

“We intend to engage the public and hold a meeting with stakeholders in the next several months to provide an opportunity for everyone with a stake in addressing drug shortages to come to the table,” Gottlieb said in the July 2018 statement. “We appreciate that lawmakers are also considering this issue. As part of the task force’s work, we’ll consider how additional authorities from Congress might help better address shortages. This engagement will be critical to informing these considerations.”

The FDA has also implemented an emerging technology program and established an emerging technology team to engage with companies about new production technologies that the agency believes could prevent drug shortages caused by product quality and manufacturing problems.

Gottlieb also addressed the FDA’s system to respond to drug shortages caused by storms and said that FDA staff stands ready to mitigate any such shortages. The FDA’s Emergency Operations Center routinely monitors storms in conjunction with other federal agencies. Part of the FDA’s monitoring is identifying FDA-regulated facilities that could be impacted by any storms.

Source: FDA