DRUG SHORTAGES

FDA’s Ability to Respond 

Should Be Strengthened

Statement of Marcia Crosse 

Director, Health Care

Testimony 

Before the Committee on Health, 

Education, Labor, and Pensions, U.S. 

Senate

For Release on Delivery 

Expected at 10:00 a.m. EST

Thursday, December 15, 2011

GAO-12-315T

United States Government Accountability Office

GAO
 

Page 1 GAO-12-315T

Mr. Chairman and Members of the Committee:

I am pleased to be here today to discuss the Food and Drug 

Administration’s (FDA) response to prescription drug shortages. 

According to FDA, a record number of drugs were in short supply in 2010, 

and the number of drug shortages has continued to grow throughout 

2011. A variety of factors can trigger drug shortages, such as disruptions 

in the supply of the active pharmaceutical ingredients required to 

manufacture the drug, manufacturing problems, manufacturers’ business 

decisions, and increased demand for products. Drug shortages directly 

threaten public health by preventing patients from accessing medications 

that are essential to their care. During shortages, physicians may have to 

ration their supplies, delay treatments, or use alternative medications that 

may be less effective for the condition, carry unwanted side effects, or 

cost more. Consistent with its mission of protecting the public health, 

FDA, an agency within the Department of Health and Human Services

(HHS), established a Drug Shortage Program to help prevent, alleviate, 

and resolve shortages.

Drug shortages may be reported to FDA by manufacturers, health 

professionals, or the public. FDA also obtains information from the 

American Society of Health-System Pharmacists (ASHP), which tracks 

and makes information publicly available about nationwide drug 

shortages through a partnership with the University of Utah Drug 

Information Service (UUDIS).1

My statement will highlight key findings from our November 2011 report, 

which is being released today, that reviews trends in prescription drug 

shortages and FDA’s response.2

 

1

ASHP posts information about drug shortages on its website. See

In that report, we (1) reviewed trends in 

prescription drug shortages that occurred from January 2001 through 

June 2011, (2) identified the reported causes of selected drug shortages 

that occurred from January 2009 through June 2011, (3) described FDA’s 

response to drug shortages, and (4) evaluated the extent to which FDA is 

able to protect the public health through its response to drug shortages.

http://www.ashp.org/menu/PracticePolicy/ResourceCenters/DrugShortages.aspx. 

2

See GAO, Drug Shortages: FDA’s Ability to Respond Should be Strengthened, 

GAO-12-116 (Washington, D.C.: Nov. 21, 2011). 

 
 

Page 2 GAO-12-315T

To identify trends in drug shortages, we analyzed UUDIS data on the 

number and duration of prescription drug shortages reported to ASHP 

from January 2001 through June 20, 2011. We examined these data 

because FDA did not have a database containing information on drug 

shortages for the time period we reviewed, and UUDIS is generally 

regarded as the most comprehensive and reliable source of such 

information. Using these data, we identified the number of drugs that had 

been in short supply on multiple occasions and the collective duration of 

these shortages. Using Red Book data, we examined the characteristics 

of 269 critical drug shortages that were identified during a shorter time 

period, January 1, 2009, through June 20, 2011.3

To identify the reported causes of selected drug shortages that occurred 

from January 2009 through June 2011, we focused our analysis on a 

nongeneralizable sample of 15 drug shortages that have had a significant 

impact on public health. The drugs involved in these shortages—all sterile 

injectables—are from three therapeutic classes: anesthesia, oncology, 

and anti-infective drugs.4

To describe FDA’s response to drug shortages, we interviewed FDA 

officials and reviewed agency documents, including policies and 

procedures. To describe how FDA responded to the 15 selected drug 

shortages we reviewed in detail, we examined information the agency 

We asked FDA officials to provide information 

on the causes of these 15 drug shortages, as reported to the agency by 

manufacturers. For additional information on the causes of shortages, we 

obtained information from four manufacturers of sterile injectable drugs—

APP Pharmaceuticals, Bedford Laboratories, Hospira, and Teva 

Pharmaceuticals. All of these manufacturers produce drugs that recently 

were in short supply, and all of the 15 drug shortages we selected for 

review involved drugs that were manufactured by one or more of these 

manufacturers.

 

3

Red Book is a compendium published by Thomson Reuters that includes information 

about the characteristics of drug products. UUDIS recognized these shortages as critical 

because alternative medications were unavailable, the shortages affected multiple 

manufacturers, or the shortages were widely reported; because the shortages were 

determined to be critical, they were posted to ASHP’s website.

4

Specifically, we reviewed information about shortages for five anesthesia drugs 

(epinephrine, neostigmine, propofol, thiopental, and succinylcholine), five oncology drugs 

(cisplatin, cytarabine, doxorubicin, etoposide, and vincristine) and five anti-infective drugs 

(acyclovir, amikacin, cefotetan, clindamycin, and sulfamethoxazole-trimethoprim). Most of 

these drugs have been available in generic form for over 15 years.
 

Page 3 GAO-12-315T

provided about its response to these shortages. We also analyzed FDA 

information on potential drug shortages the agency prevented from 

January 2010 through June 2011.

To evaluate the extent to which FDA is able to protect public health 

through its response to drug shortages, we analyzed FDA’s authority 

under the Federal Food, Drug, and Cosmetic Act, and reviewed relevant 

FDA regulations, policies, procedures, and documents. In addition, we 

evaluated FDA’s approach to managing its response to drug shortages 

using standards for internal control—including those for information and 

communications, monitoring, and risk assessment.5

In brief, we found that the number of drug shortages has grown 

substantially in recent years, and FDA is constrained in its ability to 

protect the public health from the impact of these shortages.

We also interviewed 

a variety of stakeholders—including drug manufacturers, health 

professional associations, and others involved in drug production and the 

drug supply chain—to obtain information about FDA’s response to drug 

shortages. Our work was performed in accordance with generally 

accepted government auditing standards.

• The number of drug shortages has grown substantially since 2006, 

and many shortages involved generic injectable drugs. In total, 1,190 

shortages were reported from January 1, 2001, through June 20, 

2011, according to UUDIS data. From 2006 through 2010, the number 

of drug shortages increased each year and grew by more than 200 

percent over this period. A record number of shortages (196) were 

reported in 2010, and 2011 is on pace to surpass 2010’s record, with 

146 shortages reported through June 20, 2011. Over half (64 percent) 

of the 1,190 shortages represent 283 drugs that were in short supply 

more than once. On average, these 283 drugs were each in short 

supply between two and eight times during this period, with an 

average of 2.7 times per drug. While the duration of all reported 

shortages varied considerably, most shortages lasted 1 year or less. 

On average, shortages lasted 286 days (over 9 months). Over half of 

shortages reported from January 1, 2009, through June 20, 2011, that 

UUDIS identified as critical—because, for example, alternative drugs 

were not available—involved generic injectable drugs. Certain 

 

5

See GAO, Standards for Internal Control in the Federal Government, 

GAO/AIMD-00-21.3.1 (Washington, D.C.: November 1999).
 

Page 4 GAO-12-315T

therapeutic classes (such as anesthetic, oncology, and anti-infective 

drugs) were among those most often in short supply.

• The drug shortages we reviewed in detail were generally caused by 

manufacturing problems and exacerbated by multiple difficulties. 

Twelve of the 15 drug shortages we reviewed in detail were primarily 

caused by manufacturing problems, including those that resulted in 

manufacturing shutdowns, according to information provided by FDA 

and by manufacturers. For example, one manufacturer shut down a 

facility that produces sterile injectable drugs in order to improve the 

facility’s manufacturing capabilities. While the manufacturer expected 

that the upgrade would take 3 months, it instead it took one year to 

complete, and as a result, multiple drugs that were produced at this 

facility went into short supply. The remaining 3 shortages we reviewed 

were reportedly caused by disruptions in the supply of active 

pharmaceutical ingredients. Officials from FDA and manufacturers 

explained that sterile injectable drugs are complex to make, and as 

such, can be prone to manufacturing and quality problems. In 

addition, certain types of sterile injectable drugs, such as anti-infective 

and oncology drugs, can be particularly challenging to manufacture. 

FDA also pointed out that sterile injectable drugs are being made by a 

decreasing number of aging facilities, which may contribute to the 

recent increase in manufacturing problems. In addition to the initial 

problems that caused the shortages, over half of the shortages we 

reviewed (8 of 15) were subsequently exacerbated by multiple other 

difficulties that arose after the shortages began. These 8 shortages 

were each affected by an average of four distinct difficulties that 

occurred in addition to the primary cause of the shortage and 

generally affected multiple manufacturers. During these shortages, 

multiple manufacturers sometimes experienced the same 

exacerbating issues once a shortage was already ongoing. For 

example, 9 of the 15 shortages we reviewed were extended as a 

result of manufacturing problems that occurred in addition to the 

shortages’ primary causes. It is also important to recognize that some 

drugs may only be produced by a few manufacturers. The drugs 

involved in the 15 shortages we reviewed were produced by an 

average of three manufacturers at the time the drug went into short 

supply. According to officials from FDA and industry officials, when 

only a few manufacturers make a drug and one cannot maintain 

production, it can be difficult for the other manufacturers to 

substantially increase production to ensure that demand for a drug is 

met—even in the absence of any other problems. Officials from one 

manufacturer described recent shortage situations as a perfect storm 
 

Page 5 GAO-12-315T

of several manufacturers coincidentally experiencing manufacturing 

problems all at the same time.

• FDA responds to known drug shortages by taking actions to address 

their underlying causes and to enhance product availability. FDA 

officials explained that they respond to all of the shortages of which 

the agency becomes aware, and they determine how to address each 

shortage based on its cause and the public health risk associated with 

the shortage. For example, the agency may provide assistance to 

manufacturers to resolve manufacturing or quality problems that can 

result in a shortage. Our review of FDA’s response to 15 shortages of 

sterile injectable drugs showed that FDA typically used two or more 

types of actions to respond to each shortage, and for 8 shortages, the 

agency responded with four or more types of actions. FDA most 

frequently offered assistance to manufacturers to prevent, alleviate, or 

resolve the shortage, or notified other manufacturers to expect 

increased demand or encouraged them to increase production. FDA 

has demonstrated that it can prevent the majority of shortages from 

occurring when it learns of potential supply disruptions in advance.

FDA prevented 50 potential shortages during the first half of 2011—

about 1.5 times the number of potential drug shortages (35) prevented 

during all of 2010. To prevent these potential shortages, FDA took 

some of the same types of actions it uses to alleviate and resolve 

shortages. As part of its response to drug shortages, FDA 

communicates information about shortages to the public via its 

website, which lists both current and resolved shortages.6

• FDA is constrained in its ability to protect public health from drug 

shortages. Specifically, FDA is constrained by its lack of authority to 

require manufacturers to provide the agency and the public with 

information about shortages, or require that manufacturers take 

certain actions to prevent, alleviate, or resolve shortages. FDA’s sole 

authority related to manufacturers’ reporting of drug shortages 

pertains to the discontinuation of approved drugs that are lifesupporting, life-sustaining, or for use in the prevention of a debilitating 

disease or condition, when such drugs are produced by only one 

 

6

See http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm. 
 

Page 6 GAO-12-315T

manufacturer.7 In such instances, companies are required to provide 

FDA with at least 6 months notice of discontinuations. However, such 

discontinuations have not been the primary cause of most recent drug 

shortages. As a result of these constraints, the agency’s approach to 

managing drug shortages is predominately reactive. While FDA has 

encouraged manufacturers to report supply disruptions to the agency, 

according to agency officials, less than half of all shortages are 

reported to the agency by manufacturers. Instead, FDA is most often 

notified by ASHP, health care providers, or consumers when they are 

unable to purchase a drug—a point at which the shortage is already 

affecting public health. FDA’s ability to protect public health is also 

constrained by management challenges that weaken its ability to 

respond to drug shortages. Specifically, FDA does not maintain data 

on drug shortages, such as their causes and the agency’s response. 

Without such data, FDA is unable to systematically monitor trends and 

enhance its ability to address the causes of drug shortages. In 

addition, despite the increase in the number of drug shortages 

reported in recent years, FDA has not identified drug shortages as an 

area of strategic importance for the agency. It has consistently staffed 

its Drug Shortage Program with a small number of employees. While 

FDA has recognized the significant public health consequences that 

can result from drug shortages, the agency has not developed a set of 

results-oriented performance metrics related to drug shortages, and 

has not identified drug shortages as an area of strategic importance 

for the agency. Without such management tools, FDA may be unable 

to effectively evaluate its work and improve its ability to protect the 

public health.

In conclusion, the number of drug shortages has substantially increased 

in recent years—including those for life-saving medications such as 

oncology drugs—a situation that has jeopardized the public health. While 

FDA may not always be able to prevent shortages from occurring, the 

agency’s response to drug shortages is constrained by its lack of 

authority to require manufacturers to report potential or current shortages 

to the agency. FDA has demonstrated that when it learns of shortages in 

advance, it can prevent the majority of such shortages from occurring. 

 

7

See 21 U.S.C § 356c; 21 C.F.R. § 314.81(b)(3)(iii) (2011). FDA does not have the 

authority to enforce this requirement, for example, by seeking civil monetary penalties. To 

the maximum extent possible, FDA is to distribute information on the discontinuance of 

these products to appropriate physician and patient organizations. 
 

Page 7 GAO-12-315T

However, it does not currently have the authority to require manufacturers 

to provide it with information about potential or current shortages, and 

therefore it can only prevent the shortages that it becomes aware of 

through voluntary reporting. FDA’s ability to protect the public health is 

also constrained by its own management challenges. The agency has not 

elevated the priority it places on its response to drug shortages, despite 

the rapid escalation of these shortages. Not only have its resources not 

kept pace with this escalation, the agency has not developed the metrics 

to manage this growing public health problem. Without data and resultsoriented performance measures, FDA cannot systematically monitor drug 

shortages and their causes, nor can it adequately track or assess its own 

success in preventing or mitigating shortages. Although FDA recognizes 

the serious threat these shortages pose, we believe the agency can and 

must do more to protect the public health.

Our report includes a matter for Congressional consideration that would 

establish a requirement for manufacturers to report to FDA any changes 

that could affect the supply of their drugs. In addition, our report 

recommends that FDA take steps to strengthen its ability to respond to 

drug shortages by (1) assessing the resources allocated to the Drug 

Shortage Program; (2) developing an information system to enable the 

Drug Shortage Program to manage its daily workload in a systematic 

manner, track data about drug shortages—including their causes and 

FDA’s response—and share information across FDA offices regarding 

drugs that are in short supply; (3) ensuring that FDA’s strategic plan 

articulates goals and priorities for maintaining the availability of all 

medically necessary drugs; and (4) developing results-oriented 

performance metrics to assess and quantify the implementation of the 

agency’s goals and FDA’s response to drug shortages.

In commenting on a draft of the report upon which this testimony is 

based, HHS stated that it supports legislation that would require 

manufacturers to report potential or actual supply disruptions to FDA. In 

addition, HHS outlined actions it plans to take that are consistent with our 

recommendations.

Mr. Chairman, this concludes my statement. I would be pleased to 

respond to any questions you or other Members of the Committee may 

have.
 

Page 8 GAO-12-315T

For questions about this testimony, please contact Marcia Crosse at 

(202) 512-7114 or crossem@gao.gov. Contact points for our Offices of 

Congressional Relations and Public Affairs may be found on the last page 

of this testimony. Individuals who made key contributions to this testimony 

include Geraldine Redican-Bigott, Assistant Director; Nick Bartine; 

Emily Goodman; Cathleen Hamann; Yesook Merrill; Lisa Motley; and 

Patricia Roy.

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