With U.S. drug shortages reaching record numbers, President Obama issued an executive order on Monday, directing the FDA to take steps to reduce current shortages and prevent future disruptions.
In the order, President Obama stated that, “Shortages of pharmaceutical drugs pose a serious and growing threat to public health. While a very small number of drugs in the United States experience a shortage in any given year, the number of prescription drug shortages in the United States nearly tripled between 2005 and 2010, and shortages are becoming more severe as well as more frequent. The affected medicines include cancer treatments, anesthesia drugs, and other drugs that are critical to the treatment and prevention of serious diseases and life threatening conditions.”
The President ordered the FDA to require drug manufacturers to “provide adequate advance notice of manufacturing discontinuances that could lead to shortages of drugs that are life supporting or life sustaining, or that prevent debilitating disease.”
The order also calls on the FDA to expedite “reviews of new drug suppliers, manufacturing sites and manufacturing changes” that could help avoid future shortages.
In addition, the order directs the FDA to “communicate to the Department of Justice (DOJ) any findings that shortages have led market participants to stockpile the effected drugs or sell them at exorbitant prices.”
In August, Premier healthcare alliance released an analysis of gray market prescription drug vendors that showed high price mark-ups are common on drugs that are in short supply. According to the research, 96 percent of gray market drugs were at least double the normal price; 45 percent were at least 10 times the normal price; and 27 percent were at least 20 times the normal price.