Report on Drug Shortages
 

for Calendar Year 2017
 

Required by 

Section 506C-1 of the
 

Federal Food, Drug, and Cosmetic Act
 

Food and Drug Administration
 

Department of Health and Human Services
 

_______________________________ Date_____________
 

Scott Gottlieb, M.D.
 

Commissioner of Food and Drugs
 
Table of Contents
 

EXECUTIVE SUMMARY........................................................................................................... 1
 

INTRODUCTION ..................................................................................................................... 2
 

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

1. Executive Order 13588 – Reducing Prescription Drug Shortages .............................................4
 

2. FDA Safety and Innovation Act ................................................................................................5
 

3. FDA Strategic Plan to Prevent and Mitigate Shortages .............................................................5
 

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

Biological Products.........................................................................................................................5
 

DATA SOURCES USED IN THIS REPORT ................................................................................... 6
 

ANNUAL REPORT REQUIREMENTS PER 506C-1 ....................................................................... 6
 

CONTINUED DRUG SHORTAGES EFFORTS IN 2017 ................................................................ 11
 

1. Hurricane Maria and the Impact on Puerto Rico’s Manufacturing Facilities.............................11
 

2. FDA Public Communications Regarding Drug Shortages..........................................................13
 

3. FDA Drug Shortage Assistance Award ....................................................................................13
 

4. FDA Internal Efforts Regarding Drug Shortages ......................................................................14
 

CONCLUSION....................................................................................................................... 14
 

APPENDIX 2......................................................................................................................... 16
 

APPENDIX 3......................................................................................................................... 17
 

APPENDIX 4......................................................................................................................... 18
 

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EXECUTIVE SUMMARY
 

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

Drug Administration (FDA) during calendar year (CY) 2017 to prevent or mitigate drug 

shortages1 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 manufacturers 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 Biologics Evaluation and 

Research (CBER) and FDA’s Center for Drug Evaluation and Research (CDER) worked 

with manufacturers to successfully prevent 145 shortages from January 1 to December 

31, 2017. In addition, the number of new shortages tracked by CBER and CDER for this 

same period is 39, compared to a peak of 251 new shortages during the full calendar year 

of 2011.2 

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 and biological products for the American public. 

1 For purposes of this report, the term “drug shortage” includes shortages of human drug and biological 

products. The report may individually refer to shortages tracked by FDA’s Center for Drug Evaluation and 

Research or FDA’s Center for Biologics Evaluation and Research, if the context requires distinguishing 

between these. 

2 This fifth annual report to Congress addresses all covered drug and biological products. This includes all 

drugs within the meaning of section 506C(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 

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. This also includes biological products licensed under section 351 of 

the Public Health Service Act and tracked by CBER’s Office of Compliance and Biologics Quality, such as 

vaccines and blood products. See Appendix 3 for a breakdown of 2017 CBER and CDER numbers. 

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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. 301 et seq.) 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, life-sustaining, 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 an annual report to Congress on drug 

shortages.3 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 506C1. The analyses reflect data collected and evaluated by FDA’s Center for Biologics 

Evaluation and Research (CBER) and FDA’s Center for Drug Evaluation and Research 

(CDER) from January 1, 2017, through December 31, 2017. This report also summarizes 

some important ongoing activities FDA believes will help to address drug shortages in 

the future. A list of definitions and three appendices, which include the statutory 

language regarding annual reporting on drug shortages and the breakdown of data 

supplied by CBER and CDER, are 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. 

The following figure shows the number of new drug shortages identified by year from 

2010 through December 31, 2017. 

3 Section 506C-1 of the FD&C Act initially required the annual report on drug shortages to be submitted to 

Congress “not later than the end of each calendar year.” To meet this deadline, the annual reports 

submitted to Congress presented data and information on drug shortages gathered during the first three 

quarters of the calendar year. The 21st Century Cures Act, which was enacted on December 13, 2016, 

amended section 506C-1 to require that “[n]ot later than March 31 of each calendar year, 

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, with respect to the 

preceding calendar year, on drug shortages...” 

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Figure 1. Number of New Drug Shortages Per Year, 2010 - 20174 

Although the number of new drug shortages has declined since 2011 as a result of work 

by many groups including the FDA, 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 shortage of intravenous saline solution. While there has been a steady decrease in 

new shortages over the past few years, 2017 has been a challenging year for shortages. 

First, there was a major manufacturer who shut down a facility for remediation purposes 

resulting in loss of manufacturing capacity needed for the supplies of numerous products. 

Critically, disruptions were also caused in the Fall of 2017 by Hurricanes Harvey, Irma, 

and Maria—the latter of which ravaged Puerto Rico, an island that is home to numerous 

manufacturing facilities. This created delays in the release of some products, resulting in 

both new shortages as well as the worsening of existing shortages. FDA’s efforts to 

respond to the hurricanes are summarized later in the report. 

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. As summarized below, to prevent these situations 

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. As tracked by CDER, FDA helped prevent 282 

drug shortages in 2012, 170 shortages in 2013, 101 shortages in 2014, and 142 shortages 

4 This fifth annual report to Congress is the second year to include reporting for both drug and biologic 

products. See Appendix 3 for a breakdown of 2017 CBER and CDER numbers. 

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Figure 2. Number of Prevented Drug Shortages Per Year, 2010 - 2017 6 

 

 

 

 

 

 

in 2015. In 2016, FDA, as tracked by CBER and CDER, helped to prevent 126 

shortages; in 2017, the Agency helped to prevent 145 shortages.5 

The following figure shows the number of prevented drug shortages identified by 

year from 2010 through 2017. 

Several actions have been taken in recent years that 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.”7 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 notifications and expedited reviews, as appropriate. 

5 See supra n. 2. 

6 This fifth annual report to Congress is the second year to include reporting for both drug and biologic 

products. See Appendix 3 for a breakdown of 2017 CBER and CDER numbers. 7 Executive Order 13588, available at http://www.whitehouse.gov/the-press-office/2011/10/31/executiveorder-reducing-prescription-drug-shortages 

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2.	 FDA Safety and Innovation Act 

With the passage of FDASIA on July 9, 2012, 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 life-supporting, 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 in 2014, and an additional two 

letters in 2016. 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 with respect to prescription drug 

shortages 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.8 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 shortage 

provisions of section 506C, as amended by FDASIA.9 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 

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

The rule became effective on September 8, 2015. As noted above, last year’s report to 

Congress was the first to include reporting for all covered drug and biological products. 

8 To view the strategic plan and related information, visit 

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

9 80 FR 38915 (July 8, 2015). See also 21 CFR 310.306, 314.81, and 600.82. 

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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. Tracking the data for reporting requirements related 

to drugs and biological products (the number of products in shortage) is within the 

purview of CBER’s Office of Compliance and Biologics Quality (CBER/OCBQ) and 

CDER’s Drug Shortage Staff (DSS). Similarly, CBER/OCBQ and DSS track 

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. CBER and 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 

CBER/OCBQ and 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 and the data addressing those requirements 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 calendar year 2017, FDA was notified of 520 potential drug and biological product 

shortage situations by 86 different manufacturers. 

Requirement 2: Describe the communication between FDA field investigators 

and CDER/OC and DSS, including FDA’s procedures for enabling and 

ensuring such communication. 

CDER/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 

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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 FDA medical product centers, which 

include CBER and CDER, ORA issued Field Management Directive (FMD) #15 in July 

2012. FMD #15 established drug shortage coordinators in ORA so that 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 attempting to restore 

production; 

•	 Expedite FDA inspections and reviews of submissions from competing entities 

who are interested in starting new production or increasing existing production of 

products in shortage; 

•	 Exercise temporary regulatory flexibility 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, to allow individual batches of a drug product to 

be released even when quality assurance requirements were not met. 

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. 

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 

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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 year. 

FDA expedited the review of 132 submissions in 2017.10 

•	 List the number of establishment inspections or re-inspections related to 

mitigation or prevention of a shortage that the Secretary expedited under 

section 506C(g)(2) during such calendar year.11 

FDA prioritized 30 establishment inspections to address drug shortages in 2017.12 

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 Drug 

Enforcement Administration (DEA) in efforts to prevent or mitigate the 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. 

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 

information.

13 

Requirement 5: Identify the number of (and describe) instances in which 

FDA exercised regulatory flexibility and discretion to prevent or alleviate a 

drug shortage. 

10 See Appendix 4 for a breakdown of submission types. 

11 Includes prioritized inspections or site reviews for new applications or supplements that were granted 

expedited review due to drug shortage. 

12 Note that not all submissions to FDA require inspections, but some submissions may involve multiple 

sites that require multiple inspections. 

13 The MOU can be found at 

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

MOUs/ucm440091.htm. 

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

situation. FDA’s preferred solution to a shortage is to help ensure that there is a supply 

of approved drugs and biological products 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; the Agency also 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 CY 2017, FDA exercised regulatory flexibility and discretion in 57 instances, 

affecting 33 products.14 Examples of situations in which FDA exercised regulatory 

flexibility and discretion to prevent or mitigate a shortage are listed below: 

•	 FDA used temporary regulatory flexibility and discretion for medically 

necessary products that presented 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 were supplied with a product to remove particulate matter, 

- Extra testing for product quality or identity was completed before 

releasing the product into the marketplace, 

- Third-party oversight of production was instituted to monitor quality 

issues, and 

- Special instructions were provided to health care professionals and 

patients. 

•	 FDA used temporary regulatory flexibility and discretion to permit continued 

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

FDA reviewed a supplement/proposed change to address a problem with the 

drug product. 

•	 FDA 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 were exhausted. 

•	 FDA permitted expanded access to investigational drugs for treatment use 

under an investigational new drug application (IND) (21 CFR 

312.315(a)(3)(ii)) to mitigate a shortage of an approved drug product. 

Requirement 6: List the names of manufacturers issued letters under section 

506C(f). 

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

product may involve multiple instances of regulatory flexibility. 

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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,

15 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 four non-compliance letters under section 506C(f). No letters 

were issued in 2017. The letters sent by FDA and the responses received from the 

manufacturers are available on FDA’s website. 

Requirement 7: Specify the number of drug shortages occurring during 2017. 

The data from CDER’s drug shortage database16 shows that the number of new shortages 

has significantly decreased in recent years, from 117 in 2012 to 44 in 2013, 44 in 2014, 

26 in 2015, and 26 in 2016. Unfortuanately, this downward trend did not continue into 

2017, as previously discussed. As of December 31, 2017, there were a total of 39 new 

drug and biological product shortages identified.

17 In 2017, FDA prevented 135 drug and 

biological product shortages. 

Another data point to note is the number of ongoing shortages yet to be resolved from 

previous years. FDA identified 97 ongoing CDER-tracked shortages at the end of CY 

2013, 74 ongoing CDER-tracked shortages at the end of CY 2014, 64 ongoing CDERtracked shortages at the end of CY 2015, and 48 ongoing CBER and CDER-tracked 

shortages at the end of CY 2016. As of December 31, 2017, there were 41 ongoing 

shortages, the lowest number since FDA started collecting such data. 

Figure 3. Number of Ongoing Drug Shortages Per Year, 2013 - 201718 

15 Links to letters of non-compliance with notification requirement can be found at 

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

16 CDER’s drug shortage statistics can be found at 

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

17 See Appendix 3 for a breakdown of 2017 CBER and CDER numbers. 

18 This fifth annual report to Congress is the first year to include both reporting for those covered drug and 

biologic products. See Appendix 3 for a breakdown of 2017 CBER and CDER numbers. 

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CONTINUED DRUG SHORTAGES EFFORTS IN 2017 

1.	 Hurricane Maria and the Impact on Puerto Rico’s Manufacturing 

Facilities 

Hurricane Maria devastated the Caribbean in 2017 and had a major impact on drug 

manufacturing. The FDA responded to these challenges. Given the extraordinary 

situation in Puerto Rico, FDA worked closely with local and federal authorities, and the 

manufacturers of FDA-regulated products with manufacturing facilities located in Puerto 

Rico, to help address the needs caused by challenges to the basic infrastructure in Puerto 

Rico after Hurricane Maria made landfall. FDA contacted other federal agencies and 

local authorities to assist manufacturers in addressing challenges such as gaining access 

to fuel and/or generators; clearing roads for safe travel and transport; and securing air, 

sea, and land transport priority for critical raw ingredients. Before the hurricane made 

landfall, FDA worked to identify potential risks to the drug supply. After the hurricane 

made landfall, FDA quickly worked with local and federal agencies to perform an 

assessment of impact. 

1.	 A list of high-priority FDA-regulated products with manufacturing facilities in 

Puerto Rico was identified. 

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2.	 A detailed assessment of the storm’s effects on the manufacture of these FDAregulated products was performed. 

3.	 FDA worked with all manufacturers that have facilities in Puerto Rico to 

assess the potential impacts on their facilities to avoid—whenever possible— 

shortages of critical FDA-regulated medical products. During and following 

the storm, FDA worked with manufacturers to determine whether facilities 

were damaged or not operational, or if they were still operational and could 

continue to function and manufacture on generator power. 

4.	 FDA commumnicated with outside groups and the public with updates 

concerning the overall situation in Puerto Rico and status of FDA-regulated 

products manufactured in Puerto Rico. 

5.	 FDA worked with other local and federal agencies to help get needed supplies 

and infrastructure to critical facilities. 

One particular focus of the FDA’s work after Hurricane Maria was related to the 

availability of sterile saline solution, a critical drug product used in many clinical 

situations. Sterile saline solution has been intermittently in shortage for several years as 

manufacturing capacity has worked to keep up with demand. Hurricane Maria disrupted 

the manufacturing of sterile saline solution at the Baxter Healthcare Corporation 

manufacturing facility located in Puerto Rico, resulting in a worsening of the availability 

of sterile saline solution in the United States. FDA took a variety of actions to address 

this ongoing shortage: 

1.	 FDA did not object to the temporary importation of sterile saline solutions not 

approved for use in the United States which were manufactured at Baxter 

Healthcare Facilities located in Ireland, Australia, Mexico, Canada, and 

Brazil, nor did the FDA object to the temporary importation of sterile saline 

solution not approved for use in the United States manufactured at a B. Braun 

Medical, Inc. manufacturing facility located in Germany. 

2.	 FDA expedited review of drug applications from additional manufacturers of 

sterile saline solutions to help relieve this shortage. In 2017, the Agency 

approved sterile saline solutions manufactured by Fresenius Kabi USA, LLC 

and Laboratorios Grifols, S.A., and the Agency anticipates that availability of 

these products will help to alleviate the ongoing shortage of sterile saline 

solutions. 

3.	 FDA has coordinated with outside groups to promote understanding and 

transparency regarding the saline shortage, including product utilization. 

4.	 FDA has communicated extensively about the shortage of sterile saline 

solutions.19 

19 Press announcements from FDA Commissioner Scott Gottlieb on FDA’s hurricane response: 

2018 

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm595020.htm 

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592617.htm 

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm591391.htm 

2017 

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585720.htm 

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm580290.htm 

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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 was 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, active ingredient, or 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 2016 for Android devices. Android 

device users can receive notifications when there is new or updated 

information about a shortage of a drug product or about a drug within selected 

therapeutic categories. We continue to work to have this feature available in 

the iOS format as well. As of December 31, 2017, there have been almost 

48,000 installs of the Drug Shortage App. 

Further outreach during 2017 included 10 presentations given to professional 

and patient advocacy organizations, industry and trade associations, and 

stakeholder groups. 

3. FDA Drug Shortage Assistance Award 

In September 2014, FDA created the FDA Drug Shortage Assistance Award20 

to publicly recognize drug companies and manufacturers that have 

demonstrated a commitment to preventing or alleviating drug shortages of 

medically necessary drugs. This award recognizes efforts of drug 

manufacturers who, while maintaining federally mandated quality standards, 

have worked in cooperation with FDA and implemented strategies to help 

provide a steady supply of medically necessary drugs for patients at a time 

when critical drug shortages pose a challenge for health care providers and 

patients nationwide. FDA hopes that shining a spotlight on the efforts of drug 

manufacturers that have gone above and beyond in this area will encourage 

other manufacturers to follow suit. 

On December 20, 2017, FDA issued its fourth Drug Shortage Assistance 

Award to Adienne Pharma & Biotech for its efforts in alleviating a shortage of 

thiotepa for injection, as well as submitting and obtaining approval for a new 

drug application for Tepadina (thiotepa) for injection. 

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm579493.htm 

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577338.htm 

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577112.htm

20 Information about FDA’s Drug Shortage Assistance Award can be found at 

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm415807.htm. 

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4. FDA Internal Efforts Regarding Drug Shortages 

The establishment of the Office of Pharmaceutical Quality (OPQ) within 

CDER created 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 as well as CDER/OC to assess 

drug shortage risk at manufacturing sites as a preventive effort to address 

shortages. 

DSS also works closely with CDER’s Office of Generic Drugs (OGD) and 

Office of New Drugs (OND) on shortage mitigation and prevention efforts 

and, when a product quality review is involved, DSS, OGD, and OND work 

with OPQ to ensure coordination across offices. OGD, OND, and OPQ work 

expeditiously to review and approve abbreviated and new drug applications, 

as well as supplements, for drug products that are in shortage. 

Likewise, CBER/OCBQ has procedures similar to CDER/OC and DSS, and 

works closely with all CBER product review offices concerning shortage 

mitigation and prevention efforts. CBER/OCBQ also works to facilitate and 

ensure coordination across CBER product review offices. 

CONCLUSION 

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

priority for FDA. To address them, FDA is working with manufacturers and other 

partners to help prevent shortages from occurring and to mitigate the impact of shortages 

that cannot be prevented. As a part of this work, 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 2017, FDA helped prevent 145 

potential new shortages, and there were 39 new shortages for 2017. While important 

progress has been made in preventing drug shortages from occurring, FDA continues to 

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

need. This report reflects FDA’s commitment to continue our important work to prevent 

or mitigate drug shortages. 

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APPENDIX 1 

DEFINITIONS 

Drug Shortage: A drug shortage means a period when the demand or projected demand 

for the drug within the United States exceeds the supply of the drug. 

Biological Product Shortage: A biological product shortage means a period when the 

demand or projected demand for the biological product within the United States exceeds 

the supply of the biological product. 

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

reasonably likely to lead to a reduction in the supply of a drug or biological product 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. 

Significant Disruption: A significant disruption means a change in production that is 

reasonably likely to lead to a reduction in the supply of blood or blood components by a 

manufacturer that substantially affects the ability of the manufacturer to fill orders or 

meet expected demand for its product. A significant disruption does not include 

interruptions in manufacturing due to matters such as routine maintenance or 

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

operations in a short period. 

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

describe a drug or biological 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. 

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APPENDIX 2
 

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

(a) ANNUAL REPORTS TO CONGRESS.—Not later than March 31 of each calendar 

year, 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 with respect to the preceding calendar year 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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APPENDIX 3 

Breakdown of CDER and CBER Shortage Numbers, 2017 

CDER CBER 

NEW SHORTAGES 35 4 

PREVENTED SHORTAGES 132 13 

ONGOING SHORTAGES 38 3 

NOTIFICATIONS 470 50 

NO. OF MANUFACTURERS 

NOTIFYING 

70 23 

ACTIONS TAKEN TO MITIGATE SHORTAGES 

REGULATORY FLEXIBILITY 

AND DISCRETION 

55 2 

EXPEDITED REVIEWS 116 16 

EXPEDITED INSPECTIONS 30 0 

17
 
EXPEDITED REVIEWS 

CDER NDA/NDA SUPPLEMENTS 43 

CDER ANDA/ANDA SUPPLEMENTS 71 

CDER BLA/BLA SUPPLEMENTS 2 

CBER BLA/BLA SUPPLEMENTS 16 

APPENDIX 4 

Breakdown of Expedited Reviews by Submission Type 

18