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FDA creates drug shortage plan

Manufacturers required to give early notice of potential shortfall of important medicines
FDA headquarters White Oak

Drug manufacturers will have to provide US regulators early notice of any discontinuance or interruption of manufacturing likely to disrupt the supply of important prescription drugs under new rules set by the Government.

The Food and Drug Administration (FDA) announced the action, which extends to biological products, as part of an improved plan to tackle drug shortages.

This plan is in response to a 2011 order from President Barack Obama after a spate of shortages of crucial drugs, including cancer medicines, affected the US last decade, with the number of shortages quadrupling to 251 between 2005 and 2011.

Changes to the FDA's response have improved things since then, with just 117 shortages in 2012, but the agency says more can be done and has released a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA).

The plan contains details on ways to improve the agency's response to imminent or existing shortages, and for longer-term approaches for addressing the underlying causes of drug shortages.

This includes improved communications, including a new FDA mobile app to access information on shortages, and providing clarity on what is required form a manufacturer.

The plan also acknowledges that poor manufacturing standards, such of those at Ben Venue, is one of the main reasons for drug shortages, and highlights opportunities for companies to promote and sustaining quality manufacturing to prevent future problems.

In addition to the plan, the FDA also implemented the ruling on the need for companies to provide early notification on any possible disruption to the drug supply of important medicines.

This ruling was proposed in the FDASIA and is intended to allow the FDA time to work with the manufacturers on the issues and to identify ways to make up for the shortfall in affected products.

Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), commented that early notification from manufacturers was a “critical tool that helps mitigate or prevent looming shortages”.

She also called for companies to support the FDA”s plans: “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.”

Article by
Thomas Meek

1st November 2013

From: Sales, Regulatory



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