The Food and Drug Administration has announced a pair of new measures to prevent and resolve drug shortages, which the agency called a "significant public health threat" that can impact patient access to critical medications.

Food and Drug Administration, FDA, drug shortages, Food and Drug Administration Safety and Innovation Act, FDASIA, Janet Woodcock, Center for Drug Evaluation and Research, CDER, drug manufacturers, early notification, Office of Pharmaceutical Quality

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FDA takes aim at drug shortages

November 1st, 2013

WASHINGTON – The Food and Drug Administration has announced a pair of new measures to prevent and resolve drug shortages, which the agency called a "significant public health threat" that can impact patient access to critical medications.

The FDA said Thursday that it's releasing a strategic plan to improve its response to imminent or current shortages and to provide longer-term approaches to address the causes of drug shortages.

The plan, called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, also spotlights opportunities for drug manufacturers and others to prevent drug shortages by promoting and sustaining quality manufacturing.

In addition, the FDA proposed a rule that would require all manufacturers of certain medically important prescription drugs to notify the agency of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply. The rule also extends this requirement to manufacturers of medically important biologic medicines.

The proposed rule, too, implements the expanded early notification requirements included in FDASIA.

The FDA noted that the measures build on progress made by President Obama's 2011 executive order on reducing drug shortages. Last year, the number of new shortages fell to 117 from 251 in 2011.

"The complex issue of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), said in a statement. "The FDA continues to take all steps it can within its authority, but the FDA alone cannot solve shortages. Success depends upon a commitment from all stakeholders."

According to the FDA, early notification gives the agency time to work with drug makers to investigate the causes of a manufacturing disruption, identify other manufacturers who can make up all or part of the shortfall, and expedite inspections and reviews of submissions from the makers of drugs that may prevent or mitigate a shortage.

Early notification from manufacturers about possible shortages, as requested in the President’s Executive Order 13588 of Oct. 31, 2011, and then signed into law in FDASIA, has allowed the FDA to work with manufacturers to restore production of many life-saving medications, the FDA noted, adding that it has seen a sixfold increase in notifications since the order.

That has led to "real progress" in addressing drug shortages, the FDA said. The agency helped prevent 195 shortages in 2011 and 282 shortages in 2012, resulting in fewer new shortages in 2012. The expanded early notification requirements would further enhance the FDA’s ability to address issues prior to the occurrence of a shortage.

The strategic plan, which is being sent to Congress, describes actions that the FDA will take to improve its efforts to respond to early notifications of a potential shortage. Those include improving the agency's communications about shortages — such as launching a new mobile application — so that individuals can immediately access drug shortage information via their smartphones; clarifying manufacturer roles and responsibilities by urging them to engage in certain practices that will reduce the likelihood of a shortage; and updating the FDA's internal procedures for responding to early notifications of potential shortages.

Also in the plan are initiatives that the FDA is considering to address manufacturing and quality issues that are most often the root cause of drug shortages. Those efforts include wider use of manufacturing metrics to aid in the evaluation of manufacturing quality, as well as incentives for high-quality manufacturing; internal organization improvements to focus on quality, including a proposed Office of Pharmaceutical Quality within CDER; and risk-based approaches to identify early warning signals for manufacturing and quality problems.