Executive Summary
 
This report is based on work of a Federal task force chaired by the 

U.S. Food and Drug Administration (FDA). FDA is grateful for the valuable contributions of all 

participating and consulting agencies and for their assistance in developing this report. The full version 

of this report is available on the FDA website at http://www.fda.gov/media/131130/download.

FDA thanks the following agencies for their participation in the Drug Shortages Task Force:

• Centers for Medicare and Medicaid Services, Department of Health and Human Services

• Department of Defense

• Department of Veterans Affairs

• Federal Trade Commission

• Office of the Assistant Secretary for Preparedness and Response, Department of Health

and Human Services

FDA thanks the following agencies for consultations in preparing this report:

• Defense Advanced Research Projects Agency

• U.S. Department of the Treasury

• Drug Enforcement Administration, U.S. Department of Justice

The following FDA centers and offices were instrumental in developing and producing this report:

• Office of the Commissioner

• Center for Drug Evaluation and Research

- Office of the Center Director

- Office of Compliance

- Office of Executive Programs

- Office of Generic Drugs

- Office of Pharmaceutical Quality

- Office of Regulatory Policy

- Office of Strategic Programs 

• Center for Biologics Evaluation and Research

• Center for Devices and Radiological Health

• Center for Veterinary Medicine

ACKNOWLEDGMENTS

• Office of Regulatory Affairs
A Report by the Drug Shortages Task Force 

2019 Executive Summary 

Drug Shortages:
 

Root Causes and Potential Solutions 

The full version of this report is available on the FDA website at 

http://www.fda.gov/media/131130/download 

1 
II 

Drug Shortages Pervade Many Aspects of Patient Care 

Shortages can worsen patients' health outcomes by causing delays in treatment or changes in 

treatment regimens. such as substituting less effective therapies. when a drug of choice is not 

available. Even when alternatives to the preferred drug are available. a patient's care may be 

compromised. According to a recent study. 56 percent of hospitals reported they had changed 

patient care or delayed therapy in light of drug shortages: 36.6 percent said they had rescheduled 

non-urgent or emergent procedures. 

Childhood Cancer 

Drug shortages can have a drastic impact on the 

most vulnerable patients. An estimated 90 percent 

of the 3.000 children afflicted with T-cell acute 

lymphoblastic leukemia (ALU are curable (5-year 

event-free survival). However. many of the drugs 

used to treat children with ALL (the most common 

childhood cancer) are older drugs. potentially 

making them more vulnerable to shortage. From 

2009-2019. 9 of the 11 drugs used to treat ALL were 

in and out of shortage. Despite recent evidence that 

adding nelarabine to children's treatment regimens 

improves survival rates and is thus becoming the 

new standard of care. nelarabine has been in 

shortage recently. causing much anguish and grief 

for patients. parents. and clinicians. 

'' 

"I am caring for a 12-year-old girl with newly diagnosed T-cell acute 

lymphoblastic leukemia. As soon as the diagnosis was confirmed. 

I reached out to pharmacy colleagues who confirmed that our hospital 

had no nelarabine. Nelarabine was recently proven to improve 

survival in children like my patient with T-cell ALL. Through their 

herculean efforts. enough nelarabine was secured for at least the first 

cycle of treatment. It remains to be seen whether we will be able to 

obtain enough drug for subsequent cycles." 

- Yoram Unguru, MD, MS, MA, The Children's Hospital at Sinai, Johns Hopkins Berman Institute of Bioethics 

2 
Palliative Care 

Bleomycin is used for palliative treatment of a 

number of forms of cancer including Hodgkin 

and non-Hodgkin lymphoma. In 2016. a severe 

shortage of bleomycin led to use of alternative 

treatment regimens. Although just as effective. 

the alternatives require inpatient stay. 

increasing stress for patients and families. 

potentially exposing patients to pathogens in 

the hospital environment. and substantially 

increasing costs. 

II 

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1.	 The Drug Shortages Task Force brings together officials not only from the U.S. Food and Drug Administration, but also 

from several partner agencies including the Centers for Medicare and Medicaid Services, the Department of Defense, the 

Department of Veterans Affairs, the Federal Trade Commission, and the Office of the Assistant Secretary for Preparedness 

and Response within the Department of Health and Human Services (HHS). In addition, the Task Force consulted with 

officials from the Defense Advanced Research Projects Agency, the U.S. Department of the Treasury, and the Drug 

Enforcement Administration within the U.S. Department of Justice. This Task Force is not to be confused with a previously 

established drug shortage task force, which was formed in 2012 to implement some provisions of FDASIA and has focused 

its activities on preventing and mitigating actual drug shortages. 

2.	 The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines a “drug shortage” as “a period of time when the demand or 

projected demand for the drug within the United States exceeds the supply of the drug.” FD&C Act s. 506C(h)(2) (21 U.S.C. 

356c(h)(2)). The statutory definition of “drug shortage” is not limited to medically necessary drugs. 

3.	 Section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)) provides that the term “drug” means: “(A) articles recognized in 

the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National 

Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, 

or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any 

function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in 

clause (A), (B), or (C).” 

4.	 Under certain conditions, the Animal Medicinal Drug Use Clarification Act of 1994 allows for the use of approved human 

drugs in animals. Because veterinarians, especially those in the companion animal field, often use human drugs in their 

patients, shortages of human drugs can affect veterinary medicine. 

Drug Shortages: Root Causes and Potential Solutions 

2019 Executive Summary 

I

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Information from health care providers, patients, and 

research studies suggests that the clinical and financial 

effects of shortages are substantial. 

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5.	 For purposes of this analysis, FDA defined a drug as a unique combination of active ingredient(s), route of administration, 

and dosage form — potentially grouping together multiple strengths, types of packaging, and manufacturers. These 163 

drugs corresponded to 130 shortages as defined by FDA. 

6.	 About half (47 percent) of the 163 drugs studied that went into shortage between 2013 and 2017 were both generics and 

sterile injectables. 

7.	 FDA analysis of IQVIA data. The prices are the average 12-month price prior to the shortage start date with a 3-month 

leave-out period. The prices are inflation-adjusted to August 2018 based on the Producer Price Index for Pharmaceuticals. 

Per unit means per injection for injectables, and per pill or capsule for orally administered drugs. IQVIA, formerly Quintiles 

and IMS Health, Inc., is an American multinational company serving the combined industries of health information 

technology and clinical research. 

8.	 These percentiles were calculated by comparing the earlier prices of shortage drugs to the prices of all other drugs with 

the same dosage form sold during that period. The aggregate numbers are then the mean of these percentiles within each 

group (injectables, orally administered, all drugs). 
ECONOMIC FORCES ARE THE ROOT CAUSES OF DRUG SHORTAGES 

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AND THE CONTRACTING PRACTICES THAT MAY CONTRIBUTE TO THEM 

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drug shortage list is accessible at https: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cberregulated-products-current-shortages 

10. 	 FDA publishes data on current shortages on its website and makes annual reports to Congress on the number of new 

shortages and the number of continued shortages by year, however. See https://www.fda.gov/media/130561/download 

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RECOMMENDATION 3: PROMOTE SUSTAINABLE PRIVATE SECTOR CONTRACTS 

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8 
FDA INITIATIVES TO PREVENT AND MITIGATE DRUG SHORTAGES 

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9 
CONCLUSION 

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thus reducing the risk of supply disruptions and shortages. Finally, changes in how drugs are paid for, 

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10 
CITATIONS 

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and Data Policy 

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https://aspe.hhs.gov/report/economic-analysis-causes-drug-shortages 

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https://www.ncbi.nlm.nih.gov/pubmed/21930639 

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https://www.Modernhealthcare.Com/Finance/Drug-Shortages-Drain-Least-359m-Health-Systems 

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https://www.aiche.org/resources/publications/cep/2018/december/pharmaceutical-manufacturingFXUUHQWWUHQGVDQGZKDWVQH[W

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KWWSVZZZKLGDRUJ$SSB7KHPHV0HPEHUGRFV*$Industry-Issues/Emergency-Pandemic/ 

Dept-Commerce-Study_Healthcare-Foreign-Sourcing.pdf 

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