Recent HHS Reports Highlight Need to Address Drug Shortages

John Warren, JD; James Cohen, JD; Michael Ryan, JD

May 2014, Vol 5, No 4 - Health Policy

In recent years, an increasing number of drug shortages have threatened public health by reducing—if not eliminating—patient access to critical pharmaceuticals. As such, drug shortages have been the subject of considerable federal activity, including an October 31, 2011, executive order (ie, Executive Order 13588) that directed the US Food and Drug Administration (FDA) to “take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines” (eg, requiring broader reporting of manufacturing discontinuances and expediting regulatory reviews),1 and a December 2011 interim final rule issued by the FDA that amended the FDA’s early notification requirements.2

FDA Safety and Innovation Act
Perhaps most important, however, is that the FDA Safety and Innovation Act (FDASIA) significantly enhances the FDA’s ability to identify and mitigate the effects of drug shortages, by 3:

  • Requiring all manufacturers of all covered prescription drugs (ie, drugs that are life-supporting, life-sustaining, or are intended for use in the prevention or treatment of debilitating disease or condition, including any such drug used in emergency medical care or during surgery [except for radiopharmaceuticals and other products designated by the Secretary of the US Department of Health & Human Services (HHS)]) to notify the FDA of permanent discontinuation or temporary interruption in manufacturing (before the FDASIA, this requirement applied only to sole product manufacturers)
  • Authorizing the FDA to require (by regulation) that biologic product manufacturers provide notice of permanent discontinuation or temporary interruption (previous law excluded all biologics from the reporting requirements)
  • Requiring the FDA to send a noncompliance letter to companies that fail to provide the required notice of permanent discontinuation or temporary interruption
  • Expressly permitting the FDA to continue expediting reviews and inspections that may mitigate a shortage
  • Requiring the improvement of internal and external communications by the FDA regarding shortages
  • Mandating the development and implementation of a strategic plan to help the FDA mitigate and respond to shortages
  • Triggering the initiation of a new rulemaking process (which will replace the December 2011 interim final rule) to incorporate the new requirements set forth in FDASIA.

The FDASIA also requires the HHS to submit an annual report regarding drug shortages to the Congressional Committees of Jurisdiction. On February 5, 2014, the FDA submitted its first annual report, in which it discussed actions it has taken to identify and prevent or mitigate prescription drug shortages, and described the impact drug shortages have on the healthcare system—particularly on patients and healthcare providers.4 With respect to the efficacy of the agency’s activities, the report stated that the total number of actual drug shortages decreased from 250 in 2011 to 117 in 2012, with 280 other drug shortages prevented in 2012. The FDA attributes these results to the above-described presidential, congressional, and agency activities, which have resulted in manufacturers providing the FDA with earlier notice of potential shortages, and the agency having additional time to work with sponsors and other groups to maintain patient access to critical medication.

The report also highlighted the mitigation efforts that the FDA can implement when faced with a potential shortage. Mitigation efforts may include allowing other manufacturers to increase production to make up for the shortfall; expediting reviews and inspections relating to manufacturers attempting to restore production, competing manufacturers interested in starting new production, and competing manufacturers interested in increasing the existing production of products in shortage; and exercising the temporary enforcement discretion for new sources of drugs. The FDA also noted that it exercised its regulatory flexibility in order to prevent 140 drug shortages in the first 9 months of 2013.

GAO Report
The FDASIA also requires the US Government Accountability Office (GAO) to issue a report that examines the causes of drug shortages, and formulates recommendations to prevent or minimize them. On February 10, 2014, the GAO released this analysis.5 To create this report, the GAO reviewed data, interviewed stakeholders, and performed a meta-analysis of 20 different studies and FDA data.

The GAO found that, despite the efforts of the FDA, the number of drug shortages remained high. The GAO report noted that 44% of the shortages were sterile injectable generic drugs, 17% were sterile injectable brand-name drugs, and the remainder were oral drugs. Even more disturbing, the GAO found that during the period from 2007 to 2012, nearly 50% of the reported shortages were for drugs that were in shortage multiple times.

According to the report, 4 categories of drugs—anesthetics, anti-infectives, cardiovascular agents, and nutritive drugs—accounted for 53% of critical drug shortages.5

The GAO’s analysis indicates that the majority of drug shortages (70%) are related to manufacturing quality, delays, or capacity issues. Although the report identified additional underlying factors, such as payer-related issues, particularly Medicare Part B pricing, and market-based price competition, the report did not present any of these factors as being significant causes of shortages.5

Providers indicated to the GAO that drug shortages can affect patient care beyond just the inability to access drugs in short supply. Provider groups highlighted the risks stemming from the inability to find suitable and effective alternative drugs, rationing care when drugs have limited availability, and the increased cost of short-supply drugs. Provider groups also noted that their practices were required to devote additional staff and provider time and costs on managing drug inventory instead of on providing direct patient care.5

The GAO report lauded the FDA’s efforts to identify and mitigate drug shortages. However, it noted that many contributing factors are beyond the FDA’s control. The GAO recommends that the FDA streamline its existing processes by better and more consistently using the information it collects to further enhance its ability to identify, track, and prevent drug shortages.5

Patients, providers, manufacturers, and payers alike will be encouraged by the FDA’s report of reductions in and the prevention of drug shortages. Nevertheless, the GAO’s report and remaining shortage concerns suggest that significant progress remains to be made. Therefore, where required to more fully address shortage-related issues, the FDA’s regulatory policy may evolve over time—at least to the extent required and permitted under the FDASIA.

For example, as mentioned above, the FDA intends to replace the 2011 interim final rule with regulations consistent with the FDASIA’s requirements. The comment period for the proposed replacement rule closed in early January 2014, so the FDA could promulgate the final regulations as soon as later in 2014. Therefore, interested entities—especially manufacturers—should carefully monitor communications regarding the final rule from the FDA, as well as other FDA activities under its drug shortage program.


  1. US Food and Drug Administration. Executive Order 13588—reducing prescription drug shortages. October 31, 2011. prescription-drug-shortages. Accessed May 5, 2014.
  2. US Department of Health & Human Services. Applications for Food and Drug Administration approval to market a new drug; revision of postmarketing reporting requirements—discontinuance. Fed Regist. 2011;76:78530-78540.
  3. Food and Drug Administration Safety and Inno-vation Act, Pub L No 112-144, 126 Stat 993. Accessed May 5, 2014.
  4. US Food and Drug Administration. First annual report on drug shortages for calendar year 2013. Report to Congress. February 5, 2014. Accessed May 5, 2014.
  5. US Government Accountability Office. Drug shortages: public health threat continues, despite efforts to help ensure product availability. Report to Congressional Addressees. GAO-14-194. February 2014. Accessed May 5, 2014.