March 17, 2021
ASHP applauds President Obama for signing an executive order Oct. 31, 2011, taking action on the public health crisis of prescription drug shortages. The President’s order directs the Food and Drug Administration (FDA) to broaden reporting of potential shortages, expedite regulatory reviews, and increases staffing resources for the FDA’s Drug Shortages Program.
The President also expressed support for bipartisan legislation that would require drug manufacturers to notify the FDA six months ahead of a potential shortage so that the FDA can help facilitate increased product availability from other manufacturers.
ASHP has advocated strongly in support of this legislation together with the American Hospital Association and co-conveners of a drug shortages summit last year. “The President’s leadership to address this public health crisis is an encouraging signal that we might fix the problems that are causing patients to go without life-saving drugs,” said Henri R. Manasse, Jr., Ph.D., Sc.D. “ASHP has been working hard to focus public attention on this national health crisis and we applaud President Obama for taking action today.”
The Executive Order reflects actions that ASHP has been advocating for some time, including requiring reporting of expected shortages and attention to the secondary market. “We hope this action today will help Congress move forward with the bipartisan legislation (H.R. 2245 and S. 296) as soon as possible,” said Manasse.
ASHP has also been advocating for increased FDA funding to address this and other issues through its work with the Alliance for a Stronger FDA,. “The FDA has been working hard to address drug shortage for some time, but needs more people and more funding to address the broad-based issues that cause drug shortages,” added Manasse.
ASHP reports 232 shortages in 2011 on its drug shortages resource center, which tracks shortages and provides information about alternative treatment options.
