Prescription drug shortages: Endocrine Society calls for mandatory reporting by manufacturers

The Executive Order President Obama issued Monday directing the U.S. Food and Drug Administration (FDA) to take action to reduce prescription drug shortages is a commendable first step, but the White House could strengthen its directive and address the full scope of the problem by ordering mandatory reporting by manufacturers, which The Endocrine Society calls for in its Position Statement on drug shortages.

The prescription drug shortage problem has been growing in severity and, as the Obama Administration noted, the number of shortages have nearly tripled between 2005 and 2010, going from 61 to 178. These shortages include critical medicines for endocrine-related conditions and diseases such as diabetes, hypothyroidism and thyroid cancer. The unanticipated drug shortages potentially put patients at risk because they may be unable to obtain life-sustaining prescriptions or optimal medications. Finding a solution to the drug shortage problem has proven difficult, as according to The Endocrine Society Position Statement, federal law "provides limited guidance on how the FDA should handle drug shortages and discontinuations."

The Obama Administration's Executive Order is a step in the right direction for ensuring that the FDA broadens its reporting to inform healthcare providers about drug shortages. However, the Executive Order does not adopt a key element of the Society's policy recommendation: "mandatory reporting to the FDA by drug manufacturers when a brand name or generic drug shortage or discontinuation occurs, regardless of the availability of alternative medications."

As the Society stresses, "manufacturers have demonstrated that, absent regulatory or legislative requirements, they will not consistently and voluntarily share information with the Agency (FDA). 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 the Agency (FDA) to collect and disseminate the information."

Source:

 The Endocrine Society

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