The US Food and Drug Administration (FDA) announced on 31 October 2013 that it is taking two important actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages.
For the first action, 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 strategic plan also describes efforts FDA is considering to address the manufacturing and quality issues that are most often the root cause of drug shortages. These include:
- broader use of manufacturing metrics to assist 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 FDA’s Center for Drug Evaluation and Research (CDER), and
- risk-based approaches to identify early warning signals for manufacturing and quality problems.
For the second action, FDA has issued a proposed rule requiring manufacturers of certain drugs and biologicals considered as medically important to notify FDA at least six months before they believe a product may be permanently discontinued or may experience an interruption in manufacturing. The agency says if six months’ notice is not possible, drugmakers should notify the agency about any potential shortages ‘as soon as practicable thereafter, but in no case later than five business days after the permanent discontinuance or interruption in manufacturing occurs’.
FDA states that early notification gives the agency 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 prevent or mitigate a shortage.
Drug shortages remain a major problem for FDA. Most drug shortages involve generic, sterile injectables; in 2011, these accounted for 73% of all reported drug shortages [1]. But the good news is that FDA reports that the notifications received under the existing requirements helped prevent 195 drug shortages in 2011 and 282 drug shortages in 2012, leading to a reduced number of new shortages in 2012. The agency believes that the expanded early notification requirements will further enhance FDA’s ability to address issues prior to the occurrence of a shortage.
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Source: www.gabionline.net
