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:
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
Implications 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.
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