GAO Looks at Drug Shortages, Underlying Causes, and Potential Solutions
If you have ever been told by a pharmacy that a drug prescribed for you is “unavailable,” you may find interesting a new report by the U.S. Government Accountability Office (GAO), “Drug Shortages: Threat to Public Health Persists, Despite Actions to Help Maintain Product Availability.” The GAO looks at the scope of the drug shortage problem, its underlying causes, and how the Food and Drug Administration (FDA) is attempting to respond.
The GAO reports that while new drug shortages declined in 2012, the total number of shortages each year (both new and ongoing) has increased each year since 2007. Here is GAO’s chart showing the number of active drug shortages from January 2007 through June 2013.
GAO found that many shortages are of generic sterile injectable drugs. Based on information from the University of Utah Drug Information Service, approximately 57 percent of drug shortages (219 out of 382) reported during a 13-month period ending in June 2013 were “critical shortages” because alternative medicines were not available. GAO determined that 44 percent of the critical shortages were for sterile injectable drugs. And four therapeutic classes – anti-infective, anesthetic and central nervous system, cardiovascular, and nutritive – comprised 53 percent of critical drug shortages.
In looking specifically at shortages of sterile injectable drugs, GAO found that quality problems resulting in supply disruptions and constrained manufacturing capacity were frequently cited as the immediate causes of recent drug shortages. The most frequently cited immediate cause of a drug shortage was when a manufacturer halted or slowed production after a quality problem was identified (e.g., bacterial contamination), resulting in a supply disruption. However, quality problems were not necessarily the only trigger of supply problems causing shortages. Two studies and three drug manufacturers suggested that changes in FDA inspections of manufacturing establishments also played a role. GAO concluded that other factors such as permanent product discontinuations and unavailability of raw materials play a relatively small role overall in drug shortages.
Digging deeper, GAO noted that constrained manufacturing capacity of the few existing sterile injectable drug manufacturers allows for little flexibility to increase production to respond to shortages. And GAO found that the quality problems that were the immediate causes of drug shortages were often caused by the underlying economics of the generic sterile injectable drug market. According to GAO, “The potential underlying causes cited in the literature were that competition in the generic drug market focuses primarily on price; the possible role of group purchasing organizations; and a change in Medicare Part B reimbursement policy.” The studies reviewed by GAO said all of these causes led to low profit margins, which limited infrastructure investments or led some manufacturers to exit the market.
For the last several years, the U.S. Food and Drug Administration (FDA) has focused on the problem of drug shortages. Last October, the FDA released its “Strategic Plan for Preventing and Mitigating Drug Shortages.” The FDA says it “is well positioned to play a significant role as manufacturers work to restore lost production of life-saving medications.” And FDA says it is most effective when manufacturers notify it as soon as possible when manufacturing disruptions are expected. Section 1001 of the “Food and Drug Administration Safety and Innovation Act” enacted in 2012 requires manufacturers of “life-saving” drugs to report to FDA a permanent discontinuance in the manufacture of a drug or a manufacturing interruption that is likely to lead to a meaningful disruption in U.S. supply of a drug. Under the law, these reports are due at least 6 months prior to the discontinuance or interruption or, if that isn’t possible, as soon as practicable. Under regulations proposed last November, the “as soon as practicable” requirement would be interpreted to mean “within five business days.”
An earlier Executive Order issued by President Obama had requested increased notifications by drug manufacturers. And, with these notifications, FDA said it helped prevent close to 200 drug shortages in 2011 and more than 280 in 2012. The FDA says that if notified of a potential disruption in production, it can take a number of steps, including:
- Determine if other manufacturers are willing and able to increase production;
- Expedite inspections and reviews of submissions;
- Exercise temporary enforcement discretion for new sources of medically necessary drugs;
- Work with the manufacturer to ensure adequate investigation into the root cause of the shortage; and
- Review possible risk mitigation measures for remaining inventory.
GAO found that the FDA was able to prevent 89 potential shortages in 2011, 154 potential shortages in 2012, and 50 potential shortages through June 2013. However, GAO reported that there are shortcomings in the FDA’s management of drug shortage data that are inconsistent with federal internal control standards. For example, GAO said, the FDA has not created policies or procedures governing the management of the data and has not conducted routine analyses using these data. Such shortcomings could ultimately hinder FDA’s efforts to understand the causes of specific shortages as well as undermine its efforts to prevent them from occurring.