Mitigating Drug Shortages: FDA Moves to Address Challenges

Regulatory NewsRegulatory News | 31 May 2018 | By

Building off lessons learned from the destruction caused by Hurricane Maria in Puerto Rico last year, the US Food and Drug Administration (FDA) said Thursday it has committed to taking new steps to address the root cause of drug shortages.
Allowing temporary importation of IV saline products—many of which are manufactured on the island by companies such as Baxter—is just one of the unconventional steps FDA took to address the shortage that was exacerbated by the hurricane’s destruction. FDA Commissioner Scott Gottlieb indicated FDA intends to continue considering this alternative going forward in the interest of public health.
FDA’s ability to mitigate shortages is contingent on manufacturers reporting “any disruptions, such as manufacturing changes, production or shipping delays, and product discontinuations likely to affect their supply of prescription drugs for serious illnesses,” Gottlieb noted. “This vital information allows the FDA to execute other actions within our authority to help avert impending shortages or lessen their impact,” he added.
New ways in which the agency is looking to address existing challenges and encourage companies to share more timely information about potential disruptions include providing clarifications on the information-sharing requirements, a newly implemented platform in support of production technologies such as continuous manufacturing, as well as expanding on FDA’s regulatory authority to begin requiring risk assessments of supply vulnerabilities to be conducted for certain drugs, Gottlieb said.
“Mitigating drug shortages requires a sustained effort by industry, the FDA, and other partners to return to production levels that adequately meet the needs of patients,” Gottlieb said, adding that more information on this front can be expected to come in upcoming months.


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