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FDA measures take aim at drug shortages.

WASHINGTON -- The Food and Drug Administration has outlined a new plan to prevent drug shortages and, for the first time, the measures apply to makers of biological medicines. The agency also announced that the number of new shortages fell to 117 last year, down from 251 reported in 2011.

"The FDA is releasing a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the agency's response to imminent or existing shortages and for longer-term approaches for addressing the underlying causes of drug shortages. The plan also highlights opportunities for drug manufacturers and others to prevent drug shortages by promoting and sustaining quality manufacturing," the agency said in a statement.

The FDA also issued a proposed rule requiring all manufacturers of certain medically important prescription drugs to notify the FDA of a permanent discontinuance or a temporary interruption of manufacturing that is likely to disrupt their supply. The rule would also extend this requirement to manufacturers of medically important biologic products. The proposed rule implements the expanded early notification requirements that are included in FDASIA.

"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," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER). "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 agency, early notification gives the FDA time to work with manufacturers to investigate the issue leading to the manufacturing disruption; identify other manufacturers who can make up all or part of the shortfall: and expedite inspections and reviews of submissions from manufacturers of drugs that may pre vent or mitigate a shortage.

"Early notification from manufacturers about possible shortages, as requested in the President's Executive Order 13588 of October 31, 2011, and then codified into law in FDASIA, has enabled the FDA to work with manufacturers to restore production of many lifesaving therapies. Since the executive order, there has been a sixfold increase in notifications to the FDA," noted the FDA statement.

"The notifications received under the existing requirements have resulted in real progress in addressing shortages. The FDA helped prevent 195 drug shortages in 2011 and 282 drug shortages in 2012, leading to a reduced number of 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 was required by FDASIA and has been sent to Congress, describes actions the FDA will undertake to improve its current efforts to respond to early notifications of a potential shortage. "These include improving the FDA's communications about shortages, such as launching a new mobile app, so that individuals can instantaneously access drug shortage information via their smartphones," said the statement.

Other plans include clarifying manufacturers' roles and responsibilities by encouraging 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.

The strategic plan also describes efforts the FDA is considering to address the manufacturing and quality issues that the agency asserts are most often the root cause of drug shortages, including broader use of manufacturing metrics to assist in the evaluation of manufacturing quality.
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Title Annotation:RX/Government
Publication:Chain Drug Review
Date:Nov 25, 2013
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