Drug Shortages: Certain Factors Are Strongly Associated with This Persistent Public Health Challenge, GAO-16-595: Published: Jul 7, 2016. Publicly Released: Jul 7, 2016.

“When available supplies of prescription drugs are insufficient, patient care may be adversely affected. The number of new shortages has generally decreased since 2011, while the number of ongoing shortages remained high. To help address shortages, the Food and Drug Administration (FDA) prioritized the review of—more quickly reviewed—383 drug applications and supplements during the time period GAO examined. Most were for generic sterile injectable drugs. FDA’s approval of some of these submissions occurred before the shortage was resolved. Although the timing of FDA’s approval does not establish a causal link, it could indicate that FDA’s action helped address some shortages. GAO found that, as part of FDA’s oversight of drug safety and quality, it generally issued an increasing number of warning letters to sterile injectable drug establishments during the time period GAO reviewed for noncompliance with manufacturing standards outlined in federal regulations. However, the percentage of inspections resulting in warning letters remained relatively small as the number of inspections also increased. Moreover, seven establishments that were linked to widespread shortages and received warning letters all had previous indications of difficulty complying with manufacturing standards. Shortages of sterile injectable anti-infective and cardiovascular drugs in 2012, 2013, and 2014 were strongly associated with certain factors GAO examined. Two factors—a decline in the number of suppliers and failure of at least one establishment making a drug to comply with manufacturing standards resulting in a warning letter—suggest that shortages may be triggered by supply disruptions. A third factor—drugs with sales of a generic version—suggests that due to relatively low profit margins for generic drugs, manufacturers are less likely to increase production, making the market vulnerable to shortages. The Department of Health and Human Services (HHS) reviewed a draft of this report and reiterated its commitment to addressing drug shortages. GAO incorporated HHS’s technical comments as appropriate…”