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Presidential directive addresses drug shortages, but more action needed
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The Endocrine Society commended the executive order issued by President Barack Obama directing the FDA to take action to reduce prescription drug shortages, but said the directive could benefit from ordering mandatory reporting by manufacturers.
From 2005 to 2010, the number of prescription drug shortages has almost tripled, increasing from 61 to 178, according to the Obama administration. These shortages affect critical medicines needed to treat endocrine-related conditions such as diabetes, hypothyroidism and thyroid cancer.
To date, solutions to the problem of drug shortages have been elusive. In a 2007 position statement, The Endocrine Society said federal law "provides limited guidance on how the FDA should handle drug shortages and discontinuations."
The Endocrine Society highlighted the Obama administration's executive order as a step in the right direction. The document falls short, however, because it does not call for mandatory reporting to the FDA, as the position statement recommends, when a brand name or generic drug shortage or discontinuation occurs.
"Manufacturers have demonstrated that, absent regulatory or legislative requirements, they will not consistently and voluntarily share information with the FDA," the position statement said. "As such, the most effective way to ensure that providers and patients obtain this information is to require manufacturers to report shortages and discontinuations to the FDA and to require [it] to collect and disseminate the information."
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