REPORT TO CONGRESS 

Third Annual Report on Drug Shortages 

for Calendar Year 2015 

Required by Section 1002 of the 

Food and Drug Administration Safety and Innovation Act 

Public Law 112-144 

Department of Health and Human Services 

Food and Drug Administration 
Table of Contents 

SUMMARY ................................................................................................................................... 1
 

INTRODUCTION......................................................................................................................... 1
 

BACKGROUND ........................................................................................................................... 2
 

1. Executive Order 13588 – Reducing Prescription Drug Shortages ................................ 2
 

2. FDA Safety and Innovation Act........................................................................................ 3
 

3. FDA Strategic Plan to Prevent and Mitigate Shortages ................................................. 3
 

4. Final Rule – Permanent Discontinuance or Interruption in Manufacturing of 

Certain Drug or Biological Products ....................................................................................... 3
 

DATA SOURCES USED IN THIS REPORT ............................................................................ 4
 

ANNUAL REPORT REQUIREMENTS PER 506C-1 .............................................................. 4
 

Requirement 1: Specify the number of manufacturers that submitted a notification to the 

Secretary under section 506C(a) during such calendar year .................................................... 4
 

Requirement 2: Describe the communication between FDA field investigators and CDER’s 

Office of Compliance and Drug Shortage Program, including FDA’s procedures for 

enabling and ensuring such communication .............................................................................. 4
 

Requirement 3: List the major actions taken by the Secretary to prevent or mitigate drug 

shortages ........................................................................................................................................ 5
 

Requirement 4: Describe the coordination between FDA and DEA to prevent or alleviate 

drug shortages ............................................................................................................................... 6
 

Requirement 5: Identify the number of and describe instances in which FDA exercised 

regulatory flexibility and discretion to prevent or alleviate a drug shortage .......................... 7
 

Requirement 6: List the names of manufacturers issued letters under section 506C(f) ....... 8
 

Requirement 7: Specify the number of drug shortages occurring during 2015 (the first 

three quarters of 2015) ................................................................................................................. 8
 

Figure 1. Number of New Drug Shortages Per Year, 2010 Through September 30, 2015 9
 

Figure 2. Number of Prevented Drug Shortages Per Year, 2010 Through September 30, 

2015........................................................................................................................................... 10
 

HIGHLIGHTS OF FDA WORK IN 2015 ON DRUG SHORTAGES .................................. 10
 

2
 
1. Drug Shortage Data System............................................................................................ 10
 

2. FDA Public Communications Regarding Drug Shortages........................................... 11
 

3. FDA Internal Communications Regarding Drug Shortages ....................................... 12
 

CONCLUSION ........................................................................................................................... 12
 

KEY DEFINITIONS USED IN THIS REPORT ..................................................................... 14
 

3
 
 EXECUTIVE SUMMARY 

This third annual report to Congress summarizes the major actions taken by the Food and 

Drug Administration (FDA) during the first three quarters of 2015 to prevent or mitigate 

drug shortages in the United States. Because drug shortages can pose a significant public 

health threat that can delay, and in some cases even deny, critically needed care for 

patients, shortages remain a top priority for FDA. As a result of actions by the President, 

Congress, and FDA, manufacturers are notifying FDA about potential shortages earlier 

than in the past. Early notification of potential shortages gives FDA additional time to 

work with sponsors and other stakeholders to identify ways to maintain treatment options 

and prevent a shortage. Using a range of available tools, including regulatory flexibility 

and discretion when appropriate, FDA’s Center for Drug Evaluation and Research 

(CDER) worked with manufacturers to successfully prevent 128 shortages from January 

1 to September 30, 2015. In addition, the number of new shortages tracked by CDER for 

this same time period is 22, compared with the 33 new shortages during the same time 

period for 2014. 

Based on our experience to date and the data on drug shortages presented in this report, 

FDA believes that the requirements related to early notification of potential shortages and 

FDA’s own actions are helping to reduce the threat and impact of drug shortages. FDA 

will continue to prioritize this important public health issue, working to ensure the 

availability of necessary drugs for the American public. 

INTRODUCTION 

The Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted on 

July 9, 2012. Title X of FDASIA, which addresses drug shortages, took effect on the 

date of enactment and, among other things, amended the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 355) by updating section 506C. Section 506C sets 

forth the requirement that manufacturers notify FDA of a permanent discontinuance or 

interruption in the production of certain prescription drugs that are lifesaving, lifesustaining, or intended for use in the prevention or treatment of a debilitating disease or 

condition. In addition, section 1002 of Title X of FDASIA added section 506C-1 to the 

FD&C Act, requiring FDA to file a report to Congress at the end of each calendar year on 

drug shortages. FDA is submitting this annual report to fulfill its obligations under 

section 506C-1. The report provides background about drug shortages and FDA efforts 

to address them to date. FDA also responds to the specific issues listed under section 

506C-1. The analyses reflect data collected and evaluated by CDER from January 1, 

2015, through September 30, 2015. To provide a more comprehensive view of CDER’s 

efforts to manage drug shortages, this report includes data for all products tracked by 

1 
                                                            

 

CDER’s Drug Shortage Staff (DSS).1 This report also summarizes some important 

ongoing activities FDA believes will help to address drug shortages in the future. A list 

of definitions and the statutory language regarding annual reporting on drug shortages is 

included at the end of this report. 

BACKGROUND 

Drug shortages can have serious and immediate effects on providing needed therapies to 

patients, and preventing shortages is a priority for FDA. At the height of the drug 

shortage crisis, the number of new shortages tracked by CDER quadrupled from 

approximately 61 shortages in 2005 to more than 250 in 2011. Although that number 

significantly decreased in 2012 to 117 shortages and 44 new shortages in 2013 and 44 

new shortages in 2014, shortages continue to pose a real challenge to public health. This 

is especially the case when a shortage involves a critical drug to treat cancer, to provide 

parenteral nutrition, or to address another serious medical condition, such as the current 

shortage of intravenous saline solution. These shortages can delay or deny needed care 

for patients, creating a potential lapse in medical care. Shortages can also lead 

prescribers to use second-line alternatives, which may be less effective or pose additional 

risks. To prevent these from occurring, FDA has used a variety of methods to prevent 

shortages, working within the confines of the statutory and regulatory framework in place 

and in partnership with manufacturers and other stakeholders. FDA helped prevent 282 

drug shortages in 2012, 170 shortages in 2013, 101 shortages in 2014, and 128 in the first 

three quarters of 2015. 

Several actions have been taken in recent years that have helped FDA address drug 

shortages. 

1. Executive Order 13588 – Reducing Prescription Drug Shortages 

In response to a dramatic increase in shortages, on October 31, 2011, the President issued 

Executive Order 13588, recognizing that “shortages of pharmaceutical drugs pose a 

serious and growing threat to public health...endanger patient safety...burden doctors, 

hospitals, pharmacists, and patients...and increase health care costs.”2

 The Executive 

Order acknowledged the need for a “multifaceted approach” to address the many 

different factors that contribute to drug shortages. The Executive Order directed FDA to 

take steps to help prevent and reduce current and future disruptions in the supply of 

lifesaving medicines, including through notifications and expedited reviews, as 

appropriate. 

1

 Such products include all drugs within the meaning of section 506C(h)(1), as well as other products 

tracked by CDER’s Drug Shortage Staff, such as biological products approved under section 505 of the 

FD&C Act. In the future, FDA’s annual reports on shortages may include data on biological products 

licensed under section 351 of the Public Health Service Act and tracked by the Center for Biologics 

Evaluation and Research, including vaccines and blood products. 

2

 Executive Order 13588, available at http://www.whitehouse.gov/the-press-office/2011/10/31/executiveorder-reducing-prescription-drug-shortages. 

2
 
 

                                                            

 

2.	 FDA Safety and Innovation Act 

With the passage of FDASIA, FDA was given important new authorities related to drug 

shortages. For example, section 1001 of FDASIA broadened the scope of the early 

notification provisions by requiring manufacturers of all prescription drugs that are lifesupporting, life-sustaining, or intended for use in the prevention or treatment of a 

debilitating disease or condition (whether approved or unapproved) to notify FDA of a 

permanent discontinuance or temporary interruption in manufacturing. FDASIA also 

allowed FDA to require, by regulation, early notification of discontinuances or 

interruptions in manufacturing of biologics. FDASIA requires FDA to send a noncompliance letter to firms that fail to notify FDA in accordance with section 506C, as 

amended by FDASIA. FDA sent the first two letters last year and posted the letters and 

the responses from the manufacturers on its website. No non-compliance letters were 

sent during the first three quarters of 2015. Section 506C also authorizes FDA to 

expedite reviews of drug applications and supplemental applications and to expedite 

inspections that could help mitigate a shortage. Other FDASIA requirements include 

improving FDA’s internal and external communications about shortages, improving 

communication between FDA and the Drug Enforcement Administration (DEA) 

regarding shortages of controlled substances, and developing a strategic plan to enhance 

FDA’s response to preventing and mitigating drug shortages. 

3.	 FDA Strategic Plan to Prevent and Mitigate Shortages 

On October 31, 2013, FDA issued its Strategic Plan for Preventing and Mitigating Drug 

Shortages.3 The plan contains details on the origin of drug shortages, FDA’s processes 

and procedures for helping to prevent or mitigate shortages, and FDA’s strategy for 

strengthening those processes and procedures. The plan also recommends actions that 

other stakeholders can consider to help prevent shortages. 

4.	 Final Rule – Permanent Discontinuance or Interruption in Manufacturing of 

Certain Drug or Biological Products 

On July 8, 2015, FDA published a final rule to implement certain drug shortages 

provisions of section 506C, as amended by FDASIA.4

 Among other requirements, the 

rule requires all applicants of covered approved drug or biological products, including 

certain applicants of blood or blood components for transfusion, and all manufacturers of 

covered drug products marketed without an approved application to notify FDA 

electronically of a permanent discontinuance or an interruption in manufacturing of the 

product that is likely to lead to a meaningful disruption in supply (or a significant 

3

 To view the Strategic Plan and related information, visit 

http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM372566.pdf. 

4

 21 CFR §§ 310.306, 314.81, 600.82 

3
 
 

                                                            

 

disruption in supply for blood or blood components) of the product in the United States. 

The rule became effective on September 8, 2015.5 

DATA SOURCES USED IN THIS REPORT 

The data used to fulfill the reporting requirements of section 506C-1 are collected by 

several program areas within FDA, sometimes for reasons that are broader than the FDA 

response to drug shortages. Tracking the data for reporting requirements related to drugs 

(the number of drugs in shortage) is within the purview of DSS. Similarly, DSS tracks 

information about notifications and their source (and, therefore, the number of reporting 

manufacturers). In contrast, reporting requirements related to expedited review are tied 

to specific submissions by manufacturers that are experiencing production disruptions or 

manufacturers that are adding or expanding their production capabilities to address a 

specific shortage. CDER offices reviewing these submissions track which reviews and 

related inspections they expedite as a part of a larger set of activities related to their 

review of submissions. Other reporting requirements for this report relate to instances of 

regulatory flexibility and discretion. These specific cases, all requiring separate 

regulatory and scientific evaluation and justification, are tracked by CDER’s Office of 

Compliance (CDER/OC). 

ANNUAL REPORT REQUIREMENTS PER 506C-1 

Section 1002 of Title X of FDASIA added section 506C-1 to the FD&C Act, requiring 

FDA to file a report to Congress on drug shortages at the end of each calendar year. 

The statutory requirements for the report are as follows. 

Requirement 1: Specify the number of manufacturers that submitted 

a notification to the Secretary under section 506C(a) during such 

calendar year 

For the first three quarters of calendar year 2015, FDA was notified of 131 potential 

shortage situations by 47 different manufacturers.6 

Requirement 2: Describe the communication between FDA field 

investigators and CDER’s Office of Compliance and Drug Shortage 

Program, including FDA’s procedures for enabling and ensuring 

such communication 

5

 To view the final rule and related information, visit https://www.gpo.gov/fdsys/pkg/FR-2015-07-

08/pdf/2015-16659.pdf 

6

 As noted above, this report includes data on all products tracked by CDER’s Drug Shortage Staff. 

4
 
CDER/Office of Compliance (OC) and the FDA field investigators in the Office of 

Regulatory Affairs (ORA) are crucial to FDA’s prompt response to a drug shortage. 

These two groups have separate functions with respect to drug shortages. Consistent with 

sections 506D(b) and (c) of the FD&C Act, CDER/OC communicates with DSS on 

warning letter and enforcement action recommendations being reviewed within 

CDER/OC. FDA field investigators in ORA typically conduct inspections at 

manufacturing facilities and report on their findings. For example, if the investigators 

identify actions or activities during an inspection that may have a detrimental impact on 

product availability, information regarding the observations and the products 

manufactured can be relayed to CDER immediately so that DSS can begin to assess the 

supply situation for those products. These procedures are critical to FDA’s efforts to 

prevent and mitigate a potential drug shortage. 

To facilitate communications between ORA and CDER/OC, ORA issued Field 

Management Directive, Product Shortage Communication (FMD #15), in July 2012. 

FMD #15 established drug shortage coordinators in ORA, and now each FDA field 

district has a District Drug Shortage Coordinator who serves as the point of contact 

between ORA and FDA’s medical product centers. The District Drug Shortage 

Coordinator is responsible for notifying the relevant FDA center of any issue that has the 

potential to lead to a product shortage (e.g., information obtained during an inspection or 

other field activities). FMD #15 clarified communication roles, responsibilities, and 

expectations related to potential and current product shortage situations between ORA 

and the centers. 

Requirement 3: List the major actions taken by the Secretary to 

prevent or mitigate drug shortages 

Mitigation efforts begin once FDA has confirmed that a shortage exists or could occur. 

The actions FDA can take to prevent or mitigate a shortage include, as appropriate: 

 Identify the extent of the shortfall and determine if other manufacturers are 

willing and able to increase production to make up the gap; 

 Expedite FDA inspections and reviews of submissions from manufacturers 

attempting to restore production; 

	 Expedite FDA inspections and reviews of submissions from competing 

manufacturers who are interested in starting new production or increasing existing 

production of products in shortage; 

 Exercise temporary enforcement discretion for new sources of medically 

necessary drugs; 

 Work with the affected manufacturers to ensure adequate investigation into the 

root cause of the shortage; and 

 Develop risk mitigation measures for a batch(es) of product initially not meeting 

established standards. 

FDA can use one or more of these mitigation tools, or seek to develop other options, 

depending on the severity of the potential shortage and the surrounding circumstances. 

5
 
 

                                                            

 

When selecting specific tools, FDA continues to work with the manufacturer to tailor its 

response to the specific situation. As a part of these actions, FDA also frequently 

communicates available information about a potential shortage or existing shortage to 

affected stakeholders and monitors the shortage until it has been resolved. 

	 List the number of applications and supplements for which the Secretary 

expedited review under section 506C(g)(1) during such calendar year7 

CDER expedited the review of 116 applications in the first three quarters of 2015, as 

described below: 

	 CDER’s Office of Generic Drugs (OGD) expedited the review of 102 

applications, including 62 abbreviated new drug applications and 40 

supplemental abbreviated new drug applications. 

	 CDER’s Office of Pharmaceutical Quality (OPQ) expedited 14 applications: 

10 supplemental new drug applications and 4 BLA supplemental applications. 

 List the number of establishment inspections or reinspections related to 

mitigation or prevention of a shortage that the Secretary expedited under 

section 506C(g)(2) during such calendar year8 

Eleven inspections occurred that were prioritized to address a drug shortage.9 

Requirement 4: Describe the coordination between FDA and DEA 

to prevent or alleviate drug shortages 

If a drug at risk of shortage is a controlled substance, FDA works closely with the DEA 

in efforts to prevent or mitigate its shortage. Among other issues, DEA is responsible for 

setting aggregate limits on the amount of each controlled substance that may be 

manufactured and for allocating to each manufacturer a specific percentage of the 

aggregate limit (a quota). This tight control over controlled substance products requires 

FDA and DEA to coordinate when a shortage of a controlled substance is looming. For 

example, FDA may work with DEA to enable a manufacturer to increase its allotted 

quota if this step would help avoid a shortage of the product. 

7

 Includes submissions for abbreviated new drug applications, as well as prior approval supplements (PAS) 

for new drug applications (NDAs). In some cases, changes being effected (CBE) supplements are also 

included for NDAs, where FDA determined that it was appropriate for a CBE to be submitted for a less 

significant change instead of as a PAS. FDA’s answer to requirement 3 includes data on all products 

tracked by CDER’s Drug Shortage Staff. 

8

 Includes prioritized inspections or site reviews for new applications or supplements, which were granted 

expedited review due to drug shortage. 

9

 Note that not all submissions to OGD and OPQ require inspections, but that some submissions can 

involve multiple sites, which may require inspections. 

6
 
 

                                                            

Recognizing this need, FDASIA included provisions on improved coordination and 

communication between FDA and DEA regarding a potential shortage of a controlled 

substance. To help streamline and improve communications, FDA and DEA developed a 

memorandum of understanding (MOU). The MOU sets forth steps and procedures, 

including identifying contacts, for efficiently tracking and exchanging relevant 

information10 . 

Requirement 5: Identify the number of and describe instances in 

which FDA exercised regulatory flexibility and discretion to 

prevent or alleviate a drug shortage 

FDA’s standards of safety, efficacy, and quality do not change in a shortage situation. 

FDA’s preferred solution to a shortage is a supply of approved drugs, sufficient to meet 

patient demand, as well as meet the appropriate quality, safety, and efficacy standards. 

However, FDA recognizes that there can also be risks to patients if treatment options are 

not available for critical conditions and understands the importance of using appropriate 

tools for a given situation to prevent or mitigate a shortage. In appropriate cases, the 

temporary exercise of regulatory flexibility and discretion has proven to be an important 

tool in ensuring access to treatment options for patients in critical need. 

During the first three quarters of calendar year 2015, FDA has exercised regulatory 

flexibility and discretion in 19 instances, affecting 37 products.11 Examples of situations 

in which FDA has exercised regulatory flexibility and discretion to prevent or mitigate a 

shortage are listed below: 

	 FDA has used temporary regulatory flexibility and discretion for medically 

necessary products that present quality issues through the use of measures to 

mitigate the risks associated with those products when weighed against the 

risk to patients of not receiving the drug, as follows: 

- Filters are supplied with a product to remove particulate matter, 

- Extra testing for product quality or identity is done at the manufacturing 

facility before releasing the product into the marketplace, 

- Third-party oversight of production is instituted to monitor quality issues, 

and 

- Special instructions are provided to health care professionals/patients. 

 FDA has used temporary regulatory flexibility and discretion with regard to 

continued distribution of a drug product to mitigate or resolve a drug shortage 

10 The MOU can be found at 

http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/Domestic 

MOUs/ucm440091.htm 

11 One instance of regulatory flexibility may affect more than one product. Conversely, a shortage of one 

product may involve multiple instances of regulatory flexibility. 

7
 
                                                            

while FDA reviews a supplement/proposed change to address a problem with 

the drug product. 

 FDA has used temporary regulatory flexibility and discretion with regard to 

new sources of medically necessary drugs, including FDA-registered foreign 

sources, in rare instances when all alternative approaches have been 

exhausted. 

Requirement 6: List the names of manufacturers issued letters under 

section 506C(f) 

Under section 506C(f) of the FD&C Act, if a manufacturer fails to provide notification of 

a discontinuance or interruption in manufacturing as required by section 506C, FDA must 

issue a letter to that manufacturer stating that the notification requirement was not met. 

The manufacturer is required to respond to FDA’s letter within 30 calendar days, 

providing the reason for noncompliance and the required information on the 

discontinuance or interruption. Within 45 calendar days of its original letter to the 

manufacturer, FDA is required to post that letter and any response received on FDA’s 

website,12 with appropriate redactions to protect trade secrets or confidential commercial 

information, unless FDA determines that the original notification was issued in error or, 

after review of the manufacturer’s response, that the manufacturer had a reasonable basis 

for not notifying FDA as required. 

To date, FDA has issued two non-compliance letters under section 506C(f). The first 

letter was sent on May 22, 2014, to Bristol-Myers Squibb Company and Corden Pharma 

Latina S.p.A, and the second letter was sent on August 26, 2014, to Mylan Institutional 

LLC and Agila Specialties Private Limited. The letters sent by FDA and the responses 

received from the manufacturers are available on FDA’s website. During the first three 

quarters of 2015, no non-compliance letters have been sent. 

Requirement 7: Specify the number of drug shortages occurring 

during 2015 (the first three quarters of 2015) 

Analysis of the data from CDER’s drug shortage database13shows that the number of new 

shortages significantly decreased, from 117 in 2012 to 44 in 2013, and 44 in 2014. Data 

indicate that this trend is continuing into 2015. As of September 30, 2015, 22 new drug 

shortages have been identified. The following graph shows the number of new drug 

shortages identified by year from 2010 through September 30, 2015. 

12 Links to letters of Non-Compliance With Notification Requirement can be found at 

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm403902.htm. 

13 CDER’s drug shortage statistics can be found at 

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050796.htm. 

8
 
       

Figure 1. Number of New Drug Shortages Per Year, 2010 Through September 30, 

2015 

300

178

251

117

44 44

22

0

50

100

150

200

250

Number of New Shortages

2010 2011 2012 2013 2014 2015 Q1‐Q3

Calendar Year

Source: FDA, Drug Shortage Staff

This graph illustrates the results of the work FDA and its partners are doing to 

prevent drug shortages. For example, in the first three quarters of 2015, we have 

prevented 128 shortages. The next graph shows the number of prevented drug 

shortages identified by year from 2010 through September 30, 2015. 

9
 
       

                                                            

Figure 2. Number of Prevented Drug Shortages Per Year, 2010 Through September 

30, 2015 

300

38

195

282

170

101

128

0

50

100

150

200

250

Number of Prevented Shortages

2010 2011 2012 2013 2014 2015 Q1‐Q3

Calendar Year

Source: FDA, Drug Shortage Staff

Another important piece of data is the number of ongoing or persistent shortages yet to be 

resolved from previous years. FDA identified 97 ongoing shortages at the end of 

calendar year (CY) 2013, and 74 ongoing shortages at the end of CY 2014. As of 

September 30, 2015, there were 48 ongoing shortages. 

HIGHLIGHTS OF FDA WORK IN 2015 ON DRUG SHORTAGES 

1. Drug Shortage Data System 

FDA continues to improve its system for data tracking and analysis for drug shortages 

and last year put into place a system called the Drug Shortage Data System (DSDS). 

This system was responsive to the Government Accountability Office (GAO) report on 

drug shortages,14 which made recommendations to further enhance the tracking of drug 

shortage data. The primary function of the DSDS is to streamline day-to-day work to 

identify and mitigate shortages, including research, data entry, and data management for 

14 GAO’s report can be found at http://www.gao.gov/assets/670/660785.pdf. 

10
 
                                                            

 

 

DSS. DSDS is not designed to predict whether a manufacturer or product is at risk of 

shortage. 

Ongoing work is focused on integrating DSDS with other CDER data systems, such as 

the FDA Drug Shortage website database, the Document Archiving, Reporting, and 

Regulatory Tracking System, Panorama, and the Compliance Management System. 

While this work is being done, certain processes, such as receiving notifications under 

section 506C of the FD&C Act and updating the FDA Drug Shortage website, still 

require manual input spanning multiple platforms. A longer-term goal for DSS is to 

integrate DSDS into a new system that is currently under development, called Shortage 

Tracker, which interfaces with other CDER data systems to improve its drug shortage 

tracking and reporting capabilities. 

2. FDA Public Communications Regarding Drug Shortages 

In March 2015, FDA launched its first mobile application (app) that provided the public 

with easier and faster access to important information about drug shortages. The free 

mobile app is an innovative tool designed to identify current drug shortages, resolved 

shortages, and the discontinuations of drug products. The app provides health care 

professionals and pharmacists with real-time information about drug shortages to help 

them make treatment decisions. Users of this app can search or browse by a drug’s brand 

name, generic name or active ingredient, and also by therapeutic category. The app can 

also be used to report a suspected drug shortage or supply issue to FDA. The mobile app 

was further enhanced in August for Android devices. Android device users are able to 

receive notifications when there is new or updated information about a shortage of a drug 

product or about a drug within selected therapeutic categories. As of September 30, 

2015, there have been almost 22,000 installs of the Drug Shortage App. 

This year DSS partnered with CDER/OC to publish a blog15 about the Unapproved Drugs 

Initiative and how CDER/OC works closely with DSS to ensure that the Initiative does 

not lead to an increase in drug shortages. Prescribers and their patients may sometimes 

think there is a shortage of product because once the manufacturer can produce an 

approved drug in sufficient quantities to meet market demand, the unapproved versions 

transition out of the market. To help allay such concerns, CDER/OC works closely with 

DSS to share information about the availability of the newly-approved product from the 

manufacturer, information that is then conveyed to patients and providers. 

15 FDAVoice Blog, “Reducing the number of unapproved drugs while working to prevent drug shortages: a 

job that calls for strong collaboration in FDA” can be found at 

http://blogs.fda.gov/fdavoice/index.php/2015/04/reducing-the-number-of-unapproved-drugs-whileworking-to-prevent-drug-shortages-a-job-that-calls-for-strong-collaboration-in-fda/ 

11
 
 

                                                            

 

DSS also partnered with American Society of Health-System Pharmacists to publish a 

joint piece that was featured on the Health Affairs Blog,16 to clarify any misconceptions 

on how each partner defines a drug shortage. 

The FDA Drug Shortage website enhancements provide a searchable database for 

stakeholders to obtain easy access to information about drugs in shortage, such as product 

availability, supply, and anticipated duration of shortage. This website remains a 

valuable resource to the public, with over 3.2 million page views during the first three 

quarters of 2015. 

Further outreach during the first three quarters of 2015 included eight presentations given 

to professional and patient advocacy organizations, industry and trade associations, as 

well as stakeholder groups. Additionally, the peritoneal dialysis solution shortage 

prompted FDA to publish an article in the Clinical Journal of the American Society of 

Nephrology.17 

3. FDA Internal Communications Regarding Drug Shortages 

In addition to efforts to continue to improve communication among DSS, CDER/OC, and 

ORA, new policies and procedures are being implemented regarding communications 

involving the newly created Office of Pharmaceutical Quality (OPQ) within CDER. The 

establishment of OPQ creates a single unit dedicated to product quality by improving 

FDA’s oversight of quality throughout the lifecycle of a drug product. DSS has 

important and frequent interactions with OPQ and works closely with OPQ on shortage 

mitigation and prevention efforts. 

CONCLUSION 

Drug shortages remain a significant public health issue in the United States and a top 

priority for FDA. To address them, FDA works with manufacturers to help prevent 

shortages from occurring and to mitigate the impact of shortages that cannot be 

prevented. Early and open dialogue between FDA and manufacturers is critical to our 

success. Because of important actions taken by the President and Congress, FDA has 

been able to learn of possible shortages before they occur and take steps to prevent or 

mitigate them. During the first three quarters of 2015, CDER helped prevent 128 

potential new shortages. As a result of the Agency’s work in preventing shortages, as 

16 Health Affairs Blog, “Are Shortages Going Down Or Not? Interpreting Data From The FDA And The 

University Of Utah Drug Information Service” can be found at http://healthaffairs.org/blog/2015/04/08/areshortages-going-down-or-not-interpreting-data-from-the-fda-and-the-university-of-utah-drug-informationservice/ 

17 Clinical Journal of the American Society of Nephrology: Jensen, Valerie E., and Throckmorton, Douglas 

C “Shortage of Peritoneal Dialysis Solution and the Food and Drug Administration’s Response.” CJASN 

August 07, 2015 vol. 10 no. 8 1484-1486 

12
 
well as efforts by industry and other partners, there were 22 new shortages for the first 

three quarters of 2015, which is 11 fewer new shortages than in the same period in 2014. 

This report reflects FDA’s commitment to continue our work to prevent or mitigate drug 

shortages. While important progress has been made in preventing drug shortages from 

occurring, and decreases have been seen in the total numbers of shortages, FDA 

continues to work to ensure that patients in the United States will have access to the 

medicines they need. 

13
 
KEY DEFINITIONS USED IN THIS REPORT 

Drug Shortage: A drug shortage or shortage, with respect to a drug, means a period of 

time when the demand or projected demand for the drug within the United States exceeds 

the supply of the drug. 

Meaningful Disruption: A meaningful disruption is a change in production that is 

reasonably likely to lead to a reduction in the supply of a drug by a manufacturer that is 

more than negligible and affects the ability of the manufacturer to fill orders or meet 

expected demand for its product. A meaningful disruption is not an interruption in 

manufacturing due to matters such as routine maintenance and does not include 

insignificant changes in manufacturing so long as the manufacturer expects to resume 

operations in a short period of time. 

Life Supporting or Life Sustaining: Life supporting or life sustaining is used to 

describe a drug product that is essential to, or that yields information that is essential to, 

the restoration or continuation of a bodily function important to the continuation of 

human life. 

14
 
 

 

 

APPENDIX 

SEC. 506C–1. ANNUAL REPORTING ON DRUG SHORTAGES. 

(a) ANNUAL REPORTS TO CONGRESS.—Not later than the end of calendar year 

2013, and not later than the end of each calendar year thereafter, the Secretary shall 

submit to the Committee on Energy and Commerce of the House of Representatives 

and the Committee on Health, Education, Labor, and Pensions of the Senate a report on 

drug shortages that— 

(1) specifies the number of manufacturers that submitted a notification to the Secretary 

under section 506C(a) during such calendar year; 

(2) describes the communication between the field investigators of the Food and Drug 

Administration and the staff of the Center for Drug Evaluation and Research’s Office 

of Compliance and Drug Shortage Program, including the Food and Drug 

Administration’s procedures for enabling and ensuring such communication; 

(3) (A) lists the major actions taken by the Secretary to prevent or mitigate the drug 

shortages described in paragraph (7); 

(B) in the list under subparagraph (A), includes— 

(i) the number of applications and supplements for which the Secretary 

expedited review under section 506C(g)(1) during such calendar year; and 

(ii) the number of establishment inspections or reinspections that the 

Secretary expedited under section 506C(g)(2) during such calendar year; 

(4) describes the coordination between the Food and Drug Administration and the Drug 

Enforcement Administration on efforts to prevent or alleviate drug shortages; 

(5) identifies the number of and describes the instances in which the Food and Drug 

Administration exercised regulatory flexibility and discretion to prevent or alleviate a 

drug shortage; 

(6) lists the names of manufacturers that were issued letters under section 506C(f); and 

(7) specifies the number of drug shortages occurring during such calendar year, as 

identified by the Secretary. 

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