On October 31, President Obama issued an Executive Order directing the U.S. Food and Drug Administration (FDA) to take critical steps to reduce prescription drug shortages. The Executive Order broadens the FDA’s ability to provide early notifications of potential shortages to healthcare providers and to expedite regulatory reviews that would help prevent and respond to shortages. The Administration also requested that drug manufacturers provide early notifications to the FDA regarding potential shortages and reminded them of the mandatory reporting requirements for all drug discontinuations.
The FDA released a comprehensive report in conjunction with the Executive Order that summarizes its approach to medical product shortages. The report outlines the FDA’s work with manufacturers to mitigate and prevent this significant public health problem and provides an overview of recommendations for addressing this issue in the future. Specifically, these recommendations include:
Providing additional staffing resources at the FDA to accommodate increases in drug shortage notifications from manufacturers;
Supporting legislation that makes early notification of drug shortages mandatory; and
Developing guidance to clarify information on drug shortages that are submitted by manufacturers.
The FDA’s recommendations are in line with The Endocrine Society’s position statement on monitoring and reporting drug shortages that calls for the mandatory reporting of drug shortages and the expansion of federal law to enable the FDA to distribute information to the physician community. The Society issued a press release commending the Obama Administration for its work to reduce prescription drug shortages and reiterating its support for further action that would require manufacturers to notify the FDA of potential drug shortages.