The Persistent Problem of Drug Shortages in the United States

Public discussions about the U.S. health care system often focus on new and expensive drugs, some of which have low efficacy and significant health risks. At the same time, some inexpensive and highly effective drugs are in such short supply that they are being rationed — a fact that is often ignored.

Of numerous recent examples, the shortages of two essential and inexpensive chemotherapy drugs, cisplatin and carboplatin, poignantly illustrate this disconnect. The drugs are central to treatment regimens for ovarian cancer and testicular cancer, among other malignancies, and have costs per vial of $15 and $23, respectively. As detailed in a disturbing article in the New York Times, the most recent shortages developed after the Food and Drug Administration (FDA) conducted a surprise inspection of a leading manufacturer’s plant in Ahmedabad, India. The plant shut down in late 2022 and had not reopened as of July 2023. FDA inspectors found that “employees were shredding, tearing and pouring acid on quality control records and noted a ‘cascade of failure’.” According to a physician quoted in the article, “This shortage will lead to people dying…There’s just no way around it. You cannot remove these lifesaving drugs and not have bad outcomes.”[1]

The FDA defines a drug shortage as “a period when the demand or projected demand for a drug within the United States exceeds the supply of the drug.”[2] Although exacerbated during the COVID-19 pandemic, drug shortages are a long-standing and complex problem, affecting many commonly prescribed medications. The reasons include manufacturing and quality problems, the economics of generic-drug production, increased demand for certain drugs (such as during the COVID-19 pandemic or when the influenza and respiratory virus season starts early), manufacturing delays and discontinued products. In 2022, there were 49 new drug shortages, down from a peak of 251 new shortages in 2011.[3] On July 18, 2023, the FDA’s drug shortages database listed 137 drugs in shortage and 43 shortages that had been resolved.[4] The drugs in shortage included anesthetics, antibiotics, corticosteroids (the anti-inflammatory medications often known as steroids), diuretics (medications for excess fluid) and pain relievers.

Although resolving the problem of drug shortages is an urgent public health priority, there is no one-size-fits-all approach. When the FDA learns of possible shortages before they occur, it can take preventive steps, such as allowing another company or plant to temporarily supply a drug.[5]

The FDA, however, cannot fix the economic issues for the generic-drug industry.[6] A critical need is for drug manufacturers not to rely on a single facility or geographic region for its products. When plants need to temporarily close, such as to perform routine maintenance or upgrade equipment, alternative manufacturing sites should be available. Less reliance on manufacturing facilities outside the United States, such as those in India and China, seems desirable. U.S. firms, however, also can have quality problems and financial difficulties. The infant formula shortage of 2022 was a domestic, not an international, problem. In 2023, Illinois-based Akorn Pharmaceuticals went bankrupt and abruptly closed, contributing to shortages of 14 drugs, including the asthma medicine albuterol.[7]

The bottom line is that the combined efforts of the FDA, Congress, the White House and the pharmaceutical and health care industries continue to fall short; to resolve the persistent problem of drug shortages, far more needs to be done.
 

References

[1] Jewett C. How the shortage of a $15 cancer drug is upending treatment. New York Times. June 26, 2023. https://www.nytimes.com/2023/06/26/health/cancer-drugs-shortage.html. Accessed July 18, 2023.

[2] U.S. Food & Drug Administration. Report to Congress drug shortages CY 2022. https://www.fda.gov/media/169302/download. Accessed July 17, 2023.

[3] U.S. Food & Drug Administration. Report to Congress drug shortages CY 2022. June 7, 2023. https://www.fda.gov/media/169302/download. Accessed July 17, 2023.

[4] Current and resolved drug shortages and discontinuations reported to FDA. https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm. Accessed July 17, 2023.

[5] U.S. Food & Drug Administration. Report to Congress drug shortages CY 2022. https://www.fda.gov/media/169302/download. Accessed July 17, 2023.

[6] Jewett C. Drug shortages near an all-time high, leading to rationing. New York Times. May 18, 2023. https://www.nytimes.com/2023/05/17/health/drug-shortages-cancer.html. Accessed July 17, 2023.

[7] Becker’s Hospital Review. 5 weeks later, Akorn’s closure racks up 14 swelling drug shortages. April 4, 2023. https://www.beckershospitalreview.com/pharmacy/5-weeks-later-akorns-closure-racks-up-13-swelling-drug-shortages.html. Accessed July 12, 2023.