“Drug Shortages: Root Causes and Potential Solutions” – Insight from a FDA Task Force

While there have been significant drug shortages in the past as a result of unforeseen circumstances, such as Hurricane Maria’s effect on Puerto Rico’s drug manufacturing facilities in 2017, drug shortages often crop up and continue despite no obvious reason. The ongoing shortage of vincristine, an older, traditional chemotherapy agent used for several cancers, has compelled tough decisions by providers and families. In some cases, there are few other treatment options for patients or the treatment regimen is incomplete without vincristine. Other shortages, including those for heparin, critical antimicrobials, and immunoglobulin, have also made national news. The United States (US) Food and Drug Administration (FDA) monitors and reports drug shortages and has historically worked with manufacturers and public health partners to mitigate the impact of shortages. For instance, during Hurricane Maria, the FDA allowed temporary importation of certain products from select manufacturers and worked to expedite reviews of drug applications that could alleviate shortages of affected medications. According to the FDA, the biggest causes for drug shortages are quality or manufacturing issues (37%), lack of raw materials (27%), and manufacturing delays and capacity concerns (27%).

Due to the ongoing issues associated with drug shortages and prompting from a bipartisan Congressional group in June 2018, the FDA developed an interagency Drug Shortages Task Force. This group was tasked with studying shortages, determining their root causes, and developing strategies to limit the occurrence and widespread effect of drug shortages. The Task Force evaluated products that were affected by a shortage between 2013 and 2017 and solicited public and key stakeholder feedback. In late October 2019, the FDA issued a press release announcing the publication of a report from the Task Force entitled, “Drug Shortages: Root Causes and Potential Solutions.” Notably, the Task Force confirmed that drug shortages not only persist but also have continued to rise again recently since falling from their peak in 2011. As an example of their impact, the group highlighted select medications whose shortages have had a significant clinical impact (e.g., pediatric oncology medications, medications for septic shock). Of the 163 drugs in shortage they analyzed, 63% were sterile injectables and 67% were products available as a generic. The median time since first approval was nearly 35 years and most were considered relatively “cheap,” as they were several years off-patent (median price of $2.27/unit for oral drugs and $11.05 for injectables).

The Task Force identified 3 root causes associated with drug shortages: (1) lack of incentives for manufacturing less profitable drugs; (2) lack of recognition and incentives for mature quality and production management, as well as production contingency plans; and (3) logistical and regulatory hurdles that limit production responsiveness. Moreover, the Task Force proposed solutions to alleviate the impact of drug shortages. The first recommendation is to create a shared understanding of the impact of drug shortages, including quantifying costs, frequency, persistence, and intensity, as well as improving transparency of contracted price and stipulations. The group also recommends the development of a rating system to incentivize a manufacturer’s investment in maturing quality management, beyond the minimum threshold of Current Good Manufacturing Practices (CGMPs), to improve voluntary transparency. Finally, the group recommends the promotion of sustainable private sector contracts. This recommendation would involve providing incentives for manufacturers that would mitigate the financial risk of introducing or keeping products on the market, in addition to quality-based manufacturing financial incentives. The Task Force further identified legislative proposals that could limit product availability interruptions (including improved data sharing), risk assessment to identify vulnerabilities, and additional expiration date/shelf-life data. Likewise, the Task Force also stated that the FDA plans to publish guidance for the industry. These would be regarding FDA notification of permanent or temporary manufacturing of a product and risk management plans to prevent and limit shortages.

In addition, other legislation has been proposed, such as the Mitigating Emergency Drug Shortages (MEDS) Act, introduced to legislation by Senator Susan Collins (R-ME) and Senator Tina Smith (D-MN). According to Collin’s office, shortages can add approximately $230 million in drug costs and $216 million in labor costs annually in the US. Key priorities of the Act include strengthening transparency to disclose causes, expected impact, and estimated durations of shortages; extending reporting requirements to include active ingredients (not only the finished product); requiring contingency and redundancy plans for critical medications; and incentivizing manufacturing of products in shortage. Furthermore, the proposed legislation would require the Department of Health and Human Services (DHHS) and Department of Homeland Security (DHS) to conduct a risk assessment associated with shortages of critical drugs that could affect national security. So far, the MEDS Act has support from several healthcare organizations, including the American Pharmacist’s Association (APhA), American Society of Health-System Pharmacists (ASHP), American Society of Clinical Oncology (ASCO), and the American Hospital Association (AHA).

In the meantime, drug shortages continue to creep into national news. While a lack of drug accessibility is often linked to cost, drug shortages are a reminder that cost is not the only roadblock to treatment. Despite the innovation of the US healthcare system, and the novel drug and biologic discoveries that have dramatically altered care, some Americans, because of a variety of factors and causes, still find themselves scrambling to obtain routine or essential medications.

The Drug Shortages Task Force’s report may be found here: https://www.fda.gov/media/131130/download.

 

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