Drug shortages in the U.S. continue to affect patients daily. They range from something as simple as buffered aspirin to life-saving medications such as cancer chemotherapy agents, antibiotics, and epinephrine. In the first piece of our Drug Shortage Series, we provide a brief overview of the history of drug shortages in the U.S. and how they continue to impact the industry today. 

Drug shortages have, are, and continue to cause physicians and patients significant anxiety. The effect on patients has led to many turning to alternative solutions, such as compounding pharmacies or traveling out of the country to obtain needed medication. For physicians, the challenge is the ability to prescribe medication the patient’s insurance will cover and/or that pharmacies have available and in the dosage required. Often, physicians are called to rewrite their orders one or more times due to an inability to locate the medication. These challenges, along with the theme of cost, continue to drive heightened demand for government intervention. 

FDA vs. Business 

Life sciences companies have had a longstanding relationship with the FDA. This began in 1927 when the Bureau of Chemistry from 1901 became the U.S. Food, Drug, and Insecticide Administration, and in 1930, the name shortened to the U.S. Food and Drug Administration. By 1976, the FDA gained authority over new product areas: The Bureau of Biologics, the Bureau of Radiological Health, the Bureau of Medical Devices, and the National Center for Toxicology Research.  

Over its existence, the FDA has remained committed to public health. However, as the public health crisis – along with new laws and court rulings – occurs, its mission has been updated. The crisis related to drug shortages has caused one of the adjustments. Today, according to its mission statement as related to drug shortages, the FDA has a responsibility for the safety, efficacy, and security of “…human and veterinary drugs, biological products, and medical devices; for advancing public health by helping to speed innovations that make medical products more effective, safe, and more affordable; and to get the public the accurate, science-based information on the use of medical products to maintain and improve their health.”    

Drug Shortage History  

Over the past two decades, the U.S. has been plagued by ongoing and increasing drug shortages. Due to increasing constituent pressure, in February 2011, an Executive Order was signed into law amending section 506C of the FD&C Act. This order placed the responsibility for reducing drug shortages on the FDA. It required the FDA to put into place steps to manage, monitor, and prevent drug shortages. Additionally, it further broadened the FDA’s responsibility for overseeing Manufacturing Discontinuations, specifically calling out the requirement for ensuring “adequate notice” is given prior to a drug’s discontinuation (Ex. Ord. No. 13588). 

In July 2015, section 506C was further amended to provide the FDA with clarity around which products should be focused on. The amendment clearly identified who, from a “drug shortage” perspective, must provide information along with what is required to be reported. These can be found in the document “Permanent Discontinuation or Interruption in Manufacturing of Certain Drug or Biologic Products,” which identifies the applicable drug products and biologics that are included and excluded from the current reporting requirements. This ruling requires companies who “manufacture drug products, including those that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery to notify the FDA within a minimum of six months from discontinuation. (Note: This ruling excludes radiopharmaceutical products).”  

Currently, the FDA has issued two additional draft non-binding guidance documents related to the discontinuation or interruption of Finished Products or Active Pharmaceutical Ingredients (API) along with medical devices. While both documents have yet to be approved, there is a high probability that once all public comments have been provided and reviewed, they too, will become law. These draft guidance documents provide recommendations about the requirements for notifications about production changes of certain finished drugs and biological products, APIs, and device manufacturers, as well as outlines information the FDA would like to receive in addition to the requirements. 

Monitoring

The FDA Safety and Innovation Act (FDASIA) brought about a significant change in the responsibility for life sciences companies when it was signed into law on July 9, 2012. This change requires manufacturers to notify the FDA of supply disruptions or discontinuations of products. Previously, notification was voluntary and only required when permanent discontinuations of sole source products were planned.  

Today, drug manufacturers can notify the FDA of new discontinuance, GMP issues, increase in public demand, recalls, supplier interruptions, or other events through the CDER Direct NextGen Portal. Additionally, the public, healthcare providers, and organizations can report new shortages as well as view the current shortages in the Drug Shortage Database.  

Using this reported information, the FDA has established a Drug Shortage Staff (DSS) who review the information, assess market impact and then determine what and how to work with businesses to mitigate the shortages. However, there remain challenges, as the FDA has no direct ability to affect the recovery plans related to shortages nor influence the economic decisions related to the discontinuation of a product by a company.  

Size of the Problem

While the FDA Drug Shortage Database does provide easier access to information not previously available, such as product availability, supply, and the estimated duration of the shortage, it has not reduced the number of drug shortages nor reduced the length of time a drug has remained on the list. At the end of 2023, the United States had 323 active drug shortages, and as of July 2024, this number increased by an additional 32% to 426. Of these drugs, more than half (53%) were generic sterile injectables, while 32% were solid oral drugs.  

Additionally, the average duration of drug shortages has also increased year-over-year. As of December 2023, the average drug shortage duration was 1,202 days, or over three years. Compared to 2020, the average duration of drug shortages increased by almost a full year. Furthermore, 27 of these shortages at the end of 2023 had a duration of more than five years, and six had been in shortage for over 10 years. 

According to USP, “Market forces, particularly pricing, play a significant role in drug shortages. In 2023, more than half of the injectable medications in shortage cost less than $5, and almost one-third cost less than $2. In addition, 66% of solid oral medication shortages were $3 or less. These low prices have also contributed to an increasing number of product discontinuations.” 

What is Causing These Shortages?

There are various articles that have been written on this subject, including a report to Congress on this very topic. For our upcoming series, we will focus on the July 2024 FDA shortage list and four key areas identified during our deeper dive of the items reported. Using our industry experience, along with verification of our assumptions with various outside industry professionals, we were able to categorize the shortages into four focal areas: manufacturing challenges, the discontinuation of products, material shortages required for producing drugs, and quality control issues. 

Throughout this series, we will dive deeper into what’s causing the drug shortage, explore the challenges presented with the shortage, and offer recommendations on how to overcome and improve the drug shortage issues plaguing the United States today.  

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