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EXAMINING DRUG SHORTAGES AND RECENT 

EFFORTS TO ADDRESS THEM 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

SECOND SESSION 

FEBRUARY 10, 2014 

Serial No. 113–117 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

RALPH M. HALL, Texas 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

BEN RAY LUJAN, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

RENEE L. ELLMERS, North Carolina 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

JOHN D. DINGELL, Michigan 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

GENE GREEN, Texas 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

HENRY A. WAXMAN, California (ex officio) 

(II) 

(III) 

C O N T E N T S 

Page 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 1 

Prepared statement .......................................................................................... 2 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 3 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 4 

Hon. Marsha Blackburn, a Representative in Congress from the State of 

Tennessee, opening statement ............................................................................ 5 

Hon. Fred Upton, a Representative in Congress from the State of Michigan, 

prepared statement .............................................................................................. 55 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, prepared statement ........................................................................... 57 

WITNESSES

Marcia Crosse, Director, Health Care, Government Accountability Office ......... 6 

Prepared statement .......................................................................................... 8 

Answers to submitted questions ...................................................................... 59 

Douglas C. Throckmorton, Deputy Director of Regulatory Programs, Center 

for Drug Evaluation and Research, Food and Drug Administration, Department of Health & Human Services ..................................................................... 21 

Prepared statement .......................................................................................... 23 

Answers to submitted questions ...................................................................... 71 

SUBMITTED MATERIAL

Chart, ‘‘Number of active drug shortages,’’ 2007 to June 30, 2013, Government Accountability Office analysis of University of Utah Drug Information 

Service data, submitted by Mr. Shimkus ........................................................... 48 

(1) 

EXAMINING DRUG SHORTAGES AND RECENT 

EFFORTS TO ADDRESS THEM 

MONDAY, FEBRUARY 10, 2014 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON HEALTH, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 2:00 p.m., in room 

2123, Rayburn House Office Building, Hon. Joseph R. Pitts (chairman of the subcommittee) presiding. 

Members present: Representatives Pitts, Burgess, Shimkus, 

Blackburn, Guthrie, Griffith, Ellmers, Pallone, Dingell, Barrow, 

and Christensen. 

Staff present: Clay Alspach, Chief Counsel, Health; Gary Andres, 

Staff Director; Sean Bonyun, Communications Director; Matt 

Bravo, Professional Staff Member; Noelle Clemente, Press Secretary; Paul Edattel, Professional Staff Member, Health; Sydne 

Harwick, Legislative Clerk; Carly McWilliams, Professional Staff 

Member, Health; Katie Novaria, Professional Staff Member, 

Health; Heidi Stirrup, Health Policy Coordinator; John Stone, 

Counsel, Health; Josh Trent, Professional Staff Member, Health; 

Tom Wilbur, Digital Media Advisor; Ziky Ababiya, Democratic Staff 

Assistant; and Eric Flamm, Democratic FDA Detailee. 

Mr. PITTS. The subcommittee will come to order. The Chair will 

recognize himself for an opening statement. 

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF PENNSYLVANIA 

In recent years, we have seen a dramatic increase in the number 

of drug shortages in the United States, particularly with generic 

sterile injectable drugs. While the number of new shortages dipped 

in 2012 and 2013, the total number of ongoing shortages has continued to increase. This is unacceptable. Numerous drugs have remained on FDA’s shortage list for some time. What is the Agency 

doing to help address these situations? 

Recent news reports have highlighted shortages of oncology products, parenteral nutrition products and even common, yet critically 

important, saline solutions. Such shortages lead to delays in treatment, rationing of care and higher costs. They can also pose greater risks to patients in the form of medication errors and as providers are forced to seek alternative treatments. Drug shortages 

are a very challenging problem and it is clear that there is no simVerDate Mar 15 2010 10:04 Sep 30, 2014 Jkt 037690 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 F:\113-117 DRUG SHORTAGES OK TO PRINT\113-117 DRUG SHORTAGES PDF MADE
2 

ple solution. We recognize the complicated nature of this issue as 

well as the severity. 

Last Congress, the subcommittee took action by including a section on drug shortages in the Food and Drug Administration Safety 

and Innovation Act, FDASIA, which was signed into law on July 

9th, 2012. Title 10 of FDASIA sought to address drug shortages by 

giving new authorities and responsibilities to the Food and Drug 

Administration and placing expanded requirements on drug manufacturers to notify FDA of an interruption or discontinuance in production. Among other provisions, under FDASIA, the Secretary of 

Health & Human Services is required to, one, maintain a publicly 

available up-to-date drug shortage list; two, establish a task force 

to implement a strategic plan to prevent and mitigate drug shortages; and three, submit annual reports to Congress, including relating actions taken by the Agency. FDASIA also required GAO to 

examine the cause of drug shortages and formulate recommendations on how to prevent or alleviate drug shortages. 

Last October, FDA issued its strategic plan for preventing and 

mitigating drug shortages. Further, we now have FDA’s first annual report on drug shortages, though it only covers the first three 

quarters of 2013. And today, GAO released its final report pursuant to FDASIA. 

While drug shortages continue to plague our health care system, 

statistics do indicate progress on some fronts. I am pleased to see 

that legislation coming out of this subcommittee has had a positive 

impact. 

I would like to welcome our witnesses, Marcia Crosse, health 

care director at GAO, and Douglas Throckmorton, deputy director 

of regulatory programs at the FDA. 

I would particularly like to thank GAO for their comprehensive 

report and the time they have spent with my staff on this issue. 

[The prepared statement of Mr. Pitts follows:] 

PREPARED STATEMENT OF HON. JOSEPH R. PITTS

In recent years, we have seen a dramatic increase in the number of drug shortages in the United States, particularly with generic sterile injectable drugs. 

While the number of new shortages dipped in 2012 and 2013, the total number 

of ongoing shortages has continued to increase. This is unacceptable. Numerous 

drugs have remained on FDA’s shortage list for some time. What is the agency 

doing to help address these situations? 

Recent news reports have highlighted shortages of oncology products, parenteral 

nutrition products, and even common, yet critically important saline solutions. 

Such shortages lead to delays in treatment, rationing of care, and higher costs. 

They can also pose greater risk to patients in the form of medication errors and as 

providers are forced to seek alternative treatments. 

Drug shortages are a very challenging problem and it is clear that there is no simple solution. We recognize the complicated nature of this issue as well as the severity. Last Congress, the subcommittee took action by including a section on drug 

shortages in the Food and Drug Administration Safety and Innovation Act 

(FDASIA), which was signed into law on July 9, 2012. 

Title X of FDASIA sought to address drug shortages by giving new authorities 

and responsibilities to the Food and Drug Administration and placing expanded requirements on drug manufacturers to notify FDA of an interruption or discontinuance in production. 

Among other provisions, under FDASIA, the Secretary of Health & Human Services is required to: (1) maintain a publicly available, up-to-date drug shortage list; 

(2) establish a task force to implement a strategic plan to prevent and mitigatedrug 

3 

shortages; and (3) submit annual reports to Congress including relating actions 

taken by the agency. 

FDASIA also required GAO to ‘‘examine the cause of drug shortages and formulate recommendations on how to prevent or alleviate such shortages.’’ 

Last October, FDA issued its ‘‘Strategic Plan for Preventing and Mitigating Drug 

Shortages.’’ Further, we now have FDA’s first annual report on drug shortages, 

though it only covers the first three quarters of 2013. 

And, today, GAO released its final report pursuant to FDASIA. 

While drug shortages continue to plague our healthcare system, statistics do indicate progress on some fronts. I am pleased to see that legislation coming out of this 

subcommittee has had a positive impact. 

I would like to welcome our witnesses, Marcia Crosse, Health Care Director at 

GAO, and Douglas Throckmorton, Deputy Director of Regulatory Programs at the 

FDA. I would particularly like to thank GAO for their comprehensive report and the 

time they have spent with my staff on this issue. 

Mr. PITTS. I will yield the remainder of my time to Vice Chair 

Dr. Burgess. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. Thank you, Mr. Chairman. 

You know, when doctors don’t have the essential tools, they are 

restricted in what they can do for their patients. Members of this 

committee have taken the lead and made major strides in working 

to reduce drug shortages by passing the Food and Drug Administration Safety and Innovation Act of 2012. In addition, I have 

worked very closely with Chairman Upton and Chairman Pitts on 

several of the provisions contained therein, and things have gotten 

better, but the problems have not completely gone away. 

As recently as last week, the Food and Drug Administration listed sodium chloride injection bags as a drug shortage. Now, sodium 

chloride is not a particularly esoteric or exotic molecule, so if we 

are having that much trouble with salt, it only makes you wonder 

what other more difficult molecules may—the shortages that we 

may encounter there. 

The Food and Drug Administration has a role in addressing drug 

shortages, but it is a complex issue. In 2010, over 240 drugs were 

in short supply or unavailable, and more than 400 generic equivalents were back ordered. In fact, many generic lines operate at 

margins so tight, that when production becomes corrupted, the 

company simply cannot afford to continue its manufacture. This inevitably leads to one of the more than 3,000 backlogs of generic applications. 

Physicians are still faced with having to tell patients that they 

can’t receive the care they need, not because there is no treatment 

but because a product is simply not available. 

I thank the chairman for holding this hearing so we can learn 

more about the progress that is being made on the Nation’s drug 

shortage problem. I am pleased that the Government Accountability Office report is being released and look forward to hearing 

from them on their findings. The law is aimed to ensure that providers have the tools they need to alleviate suffering, the suffering 

of every patient, and certainly, I am anxious to hear the testimony 

today. 

I yield back to the chairman. 

Mr. PITTS. The Chair thanks the gentleman. 

4 

Now yields 5 minutes for opening statement to Mr. Pallone. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. Thank you, Chairman Pitts. I am glad we are having the hearing today on this critical issue of drug shortages. 

Over the past several years, we saw an alarming trend of increases in drug shortages, and we all know the devastating effects 

this can have on patients, potentially prolonging disease or causing 

permanent disability or even death. This is an issue I and many 

of my colleagues on the committee have long been concerned about. 

Congress took action to provide the Food and Drug Administration 

with tools to help address this problem through provisions in the 

Food and Drug Administration Safety and Innovation Act, or 

FDASIA, which passed on a strong bipartisan basis in the summer 

of 2012. 

In FDASIA, we asked the Government Accountability Office to 

review several factors related to drug shortages, updating work it 

had done previously, and they released that report today. And I am 

glad Dr. Crosse is here to discuss it further with us. 

I also want to take a moment to highlight some of the other aspects of FDASIA that addressed the drug shortage problem. In its 

2012 report on drug shortages, the GAO recommended and we 

heard this from other stakeholders, too, an early notification requirement for potential shortages so that FDA can work with manufacturers sooner to take steps to prevent or mitigate shortages. 

We included such a requirement in FDASIA, and it is encouraging 

that the number of new drug shortages declined in 2012 compared 

to the previous 2 years and that partial data from 2013 indicates 

that the trend is continuing. 

The FDA has cited this and other FDASIA drug shortage provisions as contributing to their ability to prevent, by their calculation, 140 drug shortages in the first three quarters of 2013. 

We also heard from stakeholders the need for faster review times 

for generic drug applications and to reduce the significant backlog 

of pending applications, and the generic user fee agreement that 

was passed as parts of FDASIA was important in getting FDA the 

resources it needs to make that happen. 

We have learned that it can be important to have multiple manufacturers, especially for the most medically important drugs, to 

help alleviate drug shortages. As we heard from FDA a few months 

ago, the Agency has been aggressively hiring FTEs for its generic 

drug program, meeting hiring goals in the law as part of its efforts 

to tackle the backlog and speed up review times. 

And these are just some of the steps that have been taken to address drug shortages, which is, of course, a complex problem. As I 

am sure we will hear today from our witnesses, drug shortages remain high and remain a problem. Many of the shortages are still 

of sterile injectable drugs, and I am aware that these types of 

drugs face unique challenges, because they are technically difficult 

to manufacture. And each drug is often manufactured by one or a 

small number of companies, making it difficult for other companies 

5 

to be able to fill the need if any one company develops manufacturing problems. 

So it is clear that while we have made progress in some areas, 

our work is not over. I thank our witnesses from FDA and GAO 

for being here today to continue our discussion on the topic of drug 

shortages, and I look forward to learning more about what we can 

do to further prevent them. Thank you very much. 

Thank you, Mr. Chairman. I yield back. 

Mr. PITTS. At this time, the Chair recognizes the vice chair of the 

committee, the gentlelady from Tennessee, Mrs. Blackburn, for 5 

minutes for opening statement. 

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE 

Mrs. BLACKBURN. Thank you, Mr. Chairman. 

And I want to welcome our witnesses. I thank you all for being 

here. And I thank the chairman and the vice chairman of the committee for their attention to this issue. 

As you all know, 2011, 2012, we held hearings, we have looked 

at this process and what the factors are that are causing the drug 

shortages, and we know that they have increased in recent years. 

And I am one of those I believe let’s get to the root cause and to 

the root problem so that we are solving this. And I continue to talk 

with those health professionals in the community in Tennessee and 

get their input on this. 

We did take a bipartisan action, as the chairman and the ranking member have mentioned, and that was to address through 

FDASIA the shortages. And FDASIA did provide FDA with the authority that they needed. It put new requirements on the manufacturers to help prevent and to mitigate the shortages, or supposedly, 

on paper, that is what they are to do. 

So this is a wonderful opportunity for us to look at the GAO report, to question you, to hear from you and to continue to try to 

look at this systemically, holistically and to get to the root causes 

of solving this problem. 

And, Mr. Chairman, I yield back to you for further yielding. 

Mr. PITTS. The Chair thanks the gentlelady. That concludes the 

panel’s—or members’ opening statements. 

On the panel today, we have two witnesses: Dr. Marcia Crosse, 

Director of Health Care, U.S. Government Accountability Office, 

and Dr. Doug Throckmorton, Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research, U.S. Food and 

Drug Administration. 

Thank you for coming. Your written testimony will be made part 

of the record. You will have 5 minutes to summarize your opening 

statement. 

And at this time, the Chair recognizes Dr. Crosse for 5 minutes 

for her summary. 

6 

STATEMENTS OF MARCIA CROSSE, DIRECTOR, HEALTH CARE, 

GOVERNMENT ACCOUNTABILITY OFFICE, AND DOUGLAS C. 

THROCKMORTON, DEPUTY DIRECTOR OF REGULATORY 

PROGRAMS, CENTER FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION, DEPARTMENT 

OF HEALTH & HUMAN SERVICES 

STATEMENT OF MARCIA CROSSE 

Ms. CROSSE. Chairman Pitts, Ranking Member Pallone and 

members of the subcommittee, I am pleased to be here today to discuss our work on drug shortages. 

As you know, prescription drugs are a critical part of medical 

care, but over the last decade, there has been an increase in the 

number of drugs that are in shortage. This has included drugs to 

stabilize trauma victims, to control pain during surgery, to treat 

heart disease and cancer, and to provide nutritional support to premature infants. 

Today, GAO released our report on drug shortages, a study you 

mandated in the FDA Safety and Innovation Act, and I am happy 

to discuss our key findings. We found that the number of drug 

shortages remains high and that providers experience challenges 

responding to shortages without adversely affecting patient care. 

Beginning in 2007, the number of new drug shortages increased 

each year until 2012, when the number of new shortages declined, 

and that downward trend appears to have continued through 2013, 

based on the partial year data we analyzed. 

However, while the number of new drug shortages has begun to 

decline, the total number of shortages active during a given year, 

including both new shortages and ongoing shortages that began in 

a prior year, has continued to increase, because many shortages 

are prolonged, with some spanning multiple years. The majority of 

shortages are of sterile injectable drugs, particularly generics. 

Shortages of medically necessary drugs can have a range of negative effects. A drug shortage may require providers to delay or ration care, create difficulties finding alternative drugs, increase the 

risk of medication errors, lead to higher costs, reduce time for patient care, and result in the hoarding or stockpiling of drugs in 

shortage. For example, providers may have to ration care by 

prioritizing the patients who have a greater need for the drug. 

The immediate cause of a drug shortage can generally be traced 

to a manufacturer halting or slowing production to address quality 

problems, triggering a supply disruption. Other manufacturers 

have a limited ability to respond to supply disruptions due to constrained manufacturing capacity. 

We also identified potential underlying causes specific to the economics of the generic sterile injectable drug market, such as that 

low profit margins have limited infrastructure investments or led 

some manufacturers to exit the market. Although there are few 

studies of underlying causes, among the issues that have been examined are that purchasers focus primarily on price rather than 

quality, reducing incentives for manufacturers to invest in maintenance or quality improvements; that group purchasing organizations negotiate reduced drug prices on behalf of hospitals and other 

providers, lowering profit margins for manufacturers that win conVerDate Mar 15 2010 10:04 Sep 30, 2014 Jkt 037690 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 F:\113-117 DRUG SHORTAGES OK TO PRINT\113-117 DRUG SHORTAGES PDF MADE
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tracts and leading losing manufacturers to exit the market; and 

that a 2005 change in Medicare Part B drug reimbursement policy 

for outpatient providers decreased both demand and prices for generic drugs. 

The stakeholders we met with, which included manufacturers 

and group purchasing organizations, had mixed views on these potential underlying causes, with no general agreement on the role 

such factors may play. 

In examining FDA activities, we found that the Agency has prevented more potential shortages and improved its ability to respond 

to shortages in the last 2 years. The new requirement that manufacturers must notify FDA in advance of a potential shortage has 

allowed FDA to take steps to prevent and mitigate shortages sooner. For example, it has expedited application reviews and inspections, exercised enforcement discretion, and helped manufacturers 

respond to quality problems. 

These steps are important to respond to some of the immediate 

causes of shortages. However, some of the underlying causes we 

identified are beyond the Agency’s authority, as FDA does not have 

control over private companies’ business decisions. For example, 

the Agency is unable to require manufacturers to start producing 

or continue producing drugs or to build redundant manufacturing 

capacity, regardless of the severity of a shortage. 

Nonetheless, FDA can take steps to maximize the Agency’s use 

of the information it has to address drug shortages. We identified 

shortcomings in its management and use of the Agency’s drug 

shortage data. In our report, we made recommendations to FDA to 

improve its database and to conduct routine analyses, and the 

Agency has agreed with these recommendations. 

In summary, while FDA has made progress in preventing potential drug shortages and responding to actual shortages, the number 

of shortages remains high and many persist for months and even 

years. The large number of potential shortages reported to the 

Agency suggests the market is still at risk of supply disruptions. 

As a result, patients and providers will continue to struggle as essential and life-saving medications remain in short supply. 

Mr. Chairman, this completes my prepared statement, and I 

would be happy to respond to any questions you or other members 

of the subcommittee may have. 

Mr. PITTS. Thank you. 

[The prepared statement of Ms. Crosse follows:] 

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Mr. PITTS. The Chair now recognizes Dr. Throckmorton, 5 minutes to summarize his opening statement. 

STATEMENT OF DOUGLAS C. THROCKMORTON 

Mr. THROCKMORTON. Mr. Chairman and members of the subcommittee, I am Douglas Throckmorton, Deputy Director of FDA’s 

Center for Drug Evaluation and Research. Thank you for the opportunity to speak with you today about the work FDA is doing to 

address drug shortages. 

I would like to begin by discussing their causes. Drug shortages, 

as others have said, are usually preceded by a disruption in manufacturing of a product. Some product disruptions are manufacturer 

controlled, such as decisions to permanently discontinue production 

of a drug that is no longer profitable. Other factors are outside the 

manufacturer’s control, such as natural disasters or the unavailability of materials needed for manufacturing, a particular problem 

when materials are only available from one supplier. 

Most often, however, shortages are the result of quality failures 

within manufacturing facilities, such as failing to follow proper 

sterilization procedures that allow bacteria to grow in a sterile 

product. Quality failures can also result from failures to maintain 

a manufacturing line: For example, poorly maintained, old equipment has led to the introduction of iron particulates in injectable 

products. Preventing these supply disruptions requires the manufacturer to commit to quality manufacturing. 

Turning to drug shortages in the U.S. today, while work remains, 

progress has been made in the prevention and resolution of drug 

shortages in the United States. The Agency is well positioned to 

work with manufacturers to find ways to prevent or reduce a shortage’s impact on patients, provided we are aware that there is the 

potential for a shortage. Early and timely notification by manufacturers has been aided importantly by the Executive Order of the 

President as well as by passage of FDASIA and has enabled FDA 

and manufacturers to prevent 170 shortages in 2013. 

We are also seeing fewer new shortages. The number of new 

drug shortages in the United States rose steadily from 60 in 2005 

to an all-time high in 2011 of 251 new shortages. After a series of 

interventions, the number of new drug shortages has fallen to a 

low of 44 in 2013. 

There do, however, continue to be shortages that persist for 

longer periods. Here, while progress is being made, the FDA is 

tracking and working to resolve 97 total shortages that began in 

2013 or earlier. This work has been accomplished by FDA working 

closely with manufacturers, and some of the tools we have applied 

include identifying manufacturers who are willing and able to increase production of a drug in shortage; expediting FDA inspections 

and reviews of submissions, both from manufacturers that are currently producing as well as manufacturers who are interested in 

starting new production of a drug in shortage; and, finally, exploring risk mitigation measures for products initially not meeting established standards to allow them to remain available safely. 

While FDA’s standards of safety, efficacy and quality do not 

change in a shortage situation, FDA does balance our standards 

with the needs of patients for particular products, especially paVerDate Mar 15 2010 10:04 Sep 30, 2014 Jkt 037690 PO 00000 Frm 00025 Fmt 6633 Sfmt 6633 F:\113-117 DRUG SHORTAGES OK TO PRINT\113-117 DRUG SHORTAGES PDF MADE
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tients with limited treatment options. FDA makes certain that 

drug shortages are considered before taking enforcement actions or 

issuing warning letters. In appropriate cases, temporary exercise of 

regulatory flexibility is an important tool in ensuring access to 

needed drugs. 

As a part of FDA’s work on drug shortages in 2013, the FDA released its strategic plan, as called for in FDASIA. The goals of the 

plan are to improve the Agency’s response to drug shortages and 

to advance longer-term approaches for addressing the underlying 

causes of shortage. 

First, to improve how we address imminent or existing shortages, 

FDA is focusing on three areas: First, we are improving communications within CDER within the FDA to ensure that our decisions are efficient and appropriate. Second, we are improving our 

databases related to drug shortages, creating a dedicated drug 

shortage data system to improve how we track drug shortages and 

allow us to better assess progress on prevention and mitigation of 

those shortages, including the work we do to produce the annual 

report to Congress required under FDASIA. Third, FDA continues 

to work to improve timely and accurate communication about drug 

shortages to patients and caregivers. 

Recognizing that drug shortages commonly begin with the supply 

disruption related to product quality, FDA’s long-range efforts include a focus on preventing supply disruptions and shortages by 

encouraging and sustaining improvements in manufacturing quality. For over a decade, FDA has been working with academics and 

industry experts to stimulate the development of novel manufacturing technologies which can help prevent drug shortages linked 

to manufacturing quality. 

In conclusion, progress has been made in efforts to prevent and 

mitigate important drug shortages, aided by early communications 

with sponsors about potential shortages. Shortages do continue to 

occur. FDA will continue to work to address them. Importantly, 

FDA will continue to work with others to support the pharmaceutical industry in their long-term efforts to modernize drug manufacturing to prevent shortages. By working together, we can prevent drug shortages from occurring, address them when they do 

occur, and provide patients with access to medicines when they are 

in critical need. 

I am happy to answer any questions that you have. 

Mr. PITTS. The Chair thanks the gentleman. 

[The prepared statement of Mr. Throckmorton follows:] 

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36 

Mr. PITTS. That concludes the opening statements of the panel. 

We will now begin questioning, and I will recognize myself for that 

purpose for 5 minutes. 

Dr. Throckmorton, while FDASIA required that the report be 

submitted by no later than December 31st, 2013, FDA’s first annual shortages report was submitted to the committee on February 

the 5th and with data from only the first three quarters of 2013. 

You notice in your testimony that 170 new shortages were prevented in 2013. This is up from 140 in the report FDA submitted 

to the Congress. I assume that means that FDA claims to have prevented 30 shortages in the fourth quarter of the year. Is that correct? 

Mr. THROCKMORTON. We do have our full-year data available 

now, and we would be happy to share that with you, Mr. Chairman. 

Mr. PITTS. All right. Well, let’s use that smaller sample size for 

sake of discussion. It would be helpful to have more detailed information about how FDA prevented these shortages. What specific 

actions did the Agency take? Which drug products would currently 

be in shortage if not for the Agency’s actions? 

Mr. THROCKMORTON. I can get you some specific information, but 

I can give you a general sense of some of the activities that we took 

in this last year, if that would be helpful. 

Mr. PITTS. All right. 

Mr. THROCKMORTON. One issue regards something called regulatory flexibility. So these are places where we have either expedited additional actions that otherwise would have taken a bit 

longer or taken a review under hand and done additional work on 

it. And last year, we had 76 instances of regulatory flexibility that 

we exercised, affecting a total of 68 products. 

There is another way of thinking about the actions that we have 

taken recently to try to speed the development of products or assure that products that potentially go into shortage remain available; that is by looking at the kinds of expedited reviews that my 

review staff do. So several of the offices receive applications from 

sponsors for new factories, for new lines within a factory. Last 

year, my Office of Generic Drugs expedited 118 applications, involving a total of 62 accelerated new drug applications, so an important number of products where we worked hard to make certain 

that they were more quickly reviewed than normal. Our Office of 

New Drug Quality, which is another office looking at supplemental 

applications to approve drugs, approved innovator drugs, looked at 

52 supplemental applications in an expedited forum last year. And 

then finally, my Office of Biologic Products, which looks at new biologic products, obviously, a very important issue in terms of therapeutics and therapeutic development, they expedited seven reviews 

last year. 

I think, so, in total, those things reflect the kind of commitment 

that my center has to looking at these things, expediting wherever 

we are able to devote our resources to do it. 

Mr. PITTS. OK. Now, you mentioned the Office of Generic Drugs 

expedited 118 applications, including 62 abbreviated new drug applications. ANDA, is that what you call it? 

Mr. THROCKMORTON. Yes. 

37 

Mr. PITTS. In order to prevent or mitigate a shortage, how many 

of those applications were actually approved? 

Mr. THROCKMORTON. You know, I would need to get back with 

you about that information. Obviously, we are applying our usual 

standards, but 118 applications, I think, speaks to the level of effort that we undertook. 

Mr. PITTS. On average, how long did it take FDA to approve an 

ANDA that was given expedited review status? Do you know? 

Mr. THROCKMORTON. It is a good question, and I will get back 

with you with that information. 

Mr. PITTS. OK. And I would like to know more about what expedited review means in this situation. Does an ANDA referencing a 

product in shortage go to the top of the queue? Is there a special 

team within the Office of Generic Drugs responsible for moving 

them through the review process faster? 

Mr. THROCKMORTON. This will be a longer conversation. As I am 

sure you are aware, we have new resources under GDUFA, under 

the Generics Drugs User Fee Act. As a part of those resources, we 

have reorganized the Office of Generic Drugs. We are elevating it 

in terms of its importance within the Center for Drugs, and as a 

part of that action, we are looking to be as efficient as we possibly 

can. So to answer your question, I am going to need to get back 

and look at the kinds of changes that that office has made about 

the review staff. 

Mr. PITTS. All right. 

Dr. Crosse, did you have any discussions with FDA review staff 

about what it means for a shortage product to receive expedited review status within OGD? 

Ms. CROSSE. We did talk with FDA about this. We actually are 

continuing our work looking at drug shortages where we are planning on taking a more in-depth review of the number of drug shortages that have been expedited and how that relates to the number 

of applications that are sitting in the queue for drugs that are in 

shortage. One issue, of course, is that even when you expedite an 

application, if it is approved, that doesn’t mean that the manufacturer is ready to begin production that day. And there is some concern that approving one ANDA may displace another drug within 

that manufacturer’s facility if you are trying to move very quickly 

to move something to the top of the line without the sort of normal 

planning time, so that is something we heard about, but we are 

looking further to try to get some statistics for you on how frequently FDA is moving on these applications and what proportion 

of the applications are getting moved on. 

Mr. PITTS. Yes. And I would also be interested in how FDA 

works with the manufacturer to address their targets to assess 

when production capacity and output has addressed the shortage. 

My time has expired. 

The Chair recognizes the ranking member, Mr. Pallone, 5 minutes for questions. 

Mr. PALLONE. Thank you, Mr. Chairman. 

I wanted to start with Dr. Throckmorton. I would like to know 

how helpful you are finding the drug shortage provisions in 

FDASIA, and whether there are other things that you think Congress should do to help address drug shortages. And I would also 

38 

like to hear more about FDA’s strategic plan for preventing and 

mitigating drug shortages. I was pleased to see that it was released 

last October, in fulfillment of one of your FDASIA obligations. 

So essentially three questions: Would you update us on how 

things stand today with regard to drug shortages and the Agency’s 

plan to address them? And now that FDA has some experience 

with FDASIA, are there parts of the law that don’t work as intended or, you know, as well as they should? And then, third, are 

there other areas we should be thinking about to help address the 

shortages? 

Mr. THROCKMORTON. Well, thank you. So, first, let me just say 

the provision of FDASIA that expanded the notification that manufacturers have been providing for us has been enormously helpful. 

It is hard for me to overstate that. We are learning about shortages 

earlier than we had previously, and it is giving us the opportunity 

to talk with manufacturers in ways that we hadn’t had an opportunity before, and we have been able to prevent shortages as a result. So, unquestionably, that aspect of FDASIA has been useful 

from the FDA’s perspective. We continue to make use of it. As you 

know, we are continuing to write rulemaking and things related to 

it, but it is fundamentally a valuable aspect of the work that we 

are doing that is very useful. 

The other aspects of FDASIA, I think, have also been useful for 

us as well. The requirement to produce an annual report, I think, 

is valuable, because it does give us an opportunity on an annual 

basis to look back and assess whether there are things that we 

need to continue to work on or where progress has been made. 

That is a piece that we were able to provide to you recently for 

three quarters of the year’s data. We, obviously, need to update you 

with the full-year data, because we think that gives a fuller picture 

of the activities that the FDA—that the—that FDA has conducted. 

And so, fundamentally, FDASIA has been valuable to us from a 

shortage prevention strategy. 

Now, you asked us whether additional things were identified in 

the strategic plan that needed also to be done, and the short answer is yes. So there are many things that we can do internally. 

There are things that we need to do from a process perspective to 

make sure that the FDA continues to improve our responses to the 

drug shortages issue, and that—those relate, many of them, to 

process. So I chair the task force that has been steering our response to drug shortages since FDASIA’s passage. That task force 

is made up of individuals from across the Agency, so not just simply my center, but also the Center for Biologics, the inspectional 

branch of the FDA. All of us are coming together to talk about the 

things we need to do, the things that we need to communicate 

about better, to be able to, you know, basically do the job more efficiently and more appropriately. 

We also recognize we need to improve our communications. The 

communications we place on the Web site are looked at hundreds 

of thousands of times by individuals looking for information about 

shortages. We heard loud and clear when we talked to our stakeholders what needed to be improved, so that the information was 

easier to find, so that topical information was easier to identify, 

that the normal saline shortage, for instance, was at the top of the 

39 

queue, when you opened up that Web page, that you could get that 

information quickly. We have heard those kinds of comments, and 

we are doing what we can to improve those communications. 

Separately, however, there are things that are, as Dr. Crosse 

said, outside of our scope, outside of the things that the FDA is 

able to undertake. There are things that the manufacturers, we believe, have a role to explore, and there are other things that other 

stakeholders could explore as well that have great potential, I believe, in addressing the underlying causes of shortage. Happy to 

talk with you about those if you are interested. 

Mr. 1PALLONE. All right. Let me just get into one more question, 

because my time is almost gone here. One of the GAO’s recommendations is that FDA conduct routine analysis of its drug 

shortage database to identify trends, and that seems like a reasonable suggestion. Seems like FDA already does this to some extent 

but perhaps not in as formalized a process as the GAO. 

Can you just tell us a little more on the problems of the current 

FDA databases and what you hope the improvements will accomplish, and does FDA believe that performing analysis such as GAO 

recommends would help it come up with the recommendations for 

avoiding shortages? 

I think you will have 15 minutes—15 seconds. 

Mr. THROCKMORTON. Fundamentally, we agree with the recommendations that the GAO has made. We understand that the 

quality of the decisionmaking that we can have with regards to 

shortage depends on the quality of the data. So we are putting in 

place a new drug shortage data system that is going to make the 

data more robust, make it more standardized and improve our assessment of those data. 

Mr. PALLONE. OK. All right. Thanks a lot. 

Thanks, Mr. Chairman. 

Mr. PITTS. The Chair thanks the gentleman. 

Now recognize the gentlelady from Tennessee, Mrs. Blackburn, 5 

minutes for questions. 

Mrs. BLACKBURN. Thank you, Mr. Chairman. 

And, again, I thank each of you for being here with us. 

I want to—I have got just a couple of questions. I know that the 

FDA report said, you know, the number of reported new shortages 

has declined in 2012 and for the first three quarters of 2013, but 

then GAO says the total number of active shortages continues to 

be high. So do you each agree with that? 

Dr. Crosse? 

Ms. CROSSE. Yes, we do agree. The number of new shortages has 

decreased, and we think that the FDASIA early notification has 

been very helpful in that regard, but a number of shortages have 

persisted across time. 

Mrs. BLACKBURN. OK. 

Ms. CROSSE. I think we present that information in our report. 

Mrs. BLACKBURN. Yes, you do. 

Dr. Throckmorton, do you continue to—do you agree with that, 

that the shortages continue to be too high? 

Mr. THROCKMORTON. Absolutely. I mean—— 

40 

Mrs. BLACKBURN. OK. Just want to be sure everybody is in complete agreement on that, because what I am hearing from the providers in Tennessee, they agree with the GAO report. 

And, Dr. Throckmorton, they look at yours, and it is kind of a 

head scratcher, because they are not seeing the amount of improvement that your report would lead people to believe is there. And 

we continue to hear about the shortages with the generic sterile 

injectable drugs, the IV fluids, the medications for anesthesia, some 

of the cancer therapies. So these are problems, and you might be 

making some progress, but it is not coming fast enough. 

And so let’s talk about FDA implementing the system and preventing—getting to the point that they can prevent new shortages 

and decrease the backlog of the current shortages. 

So, Ms. Crosse, give me the couple of things that we need to be 

holding them responsible for doing. What is going to speed this up, 

because we can’t do this where we are saying 10 years from now, 

we are going to have this in place? 

Ms. CROSSE. Well, we do continue to look at some of the underlying causes. You know, I think we need to look a little more closely at those generic drug applications that are sitting at FDA and 

the extent to which FDA has been able to expedite the applications, 

which could be something that would help, but—— 

Mrs. BLACKBURN. OK. Let me. 

Ms. CROSSE [continuing]. There are still a number of—— 

Mrs. BLACKBURN. If I can engage you right there for just a 

minute. 

Ms. CROSSE. Sure. 

Mrs. BLACKBURN. So Dr. Throckmorton, you said you expedited 

118 this year. 

Mr. THROCKMORTON. Generic applications, yes. 

Mrs. BLACKBURN. OK. 

Dr. Crosse, what would be a better number? What—if you were 

setting a goal for him, how many should they be expediting every 

year? Two hundred? 

Ms. CROSSE. I don’t know. 

Mrs. BLACKBURN. You don’t know. 

Ms. CROSSE. I don’t know. And I think there is a concern that 

if you expedite too many, that then you are creating a clog at the 

top. 

Mrs. BLACKBURN. OK. 

Ms. CROSSE. It is difficult. You need—you know, there—even 

within the priorities—— 

Mrs. BLACKBURN. Thank you. So—— 

Ms. CROSSE [continuing]. There are priorities. 

Mrs. BLACKBURN [continuing]. It may be approved, but then they 

can’t put it straight into manufacturing. 

Ms. CROSSE. Right. So there needs to be conversations with the 

manufacturers about how quickly they could come on line. 

Mrs. BLACKBURN. So they need to be engaging them on the front 

end rather than the back end—— 

Ms. CROSSE. Yes. 

Mrs. BLACKBURN [continuing]. Or at the point of approval. 

Would predictability in this process with the review system, because as I talked to some that are working in the generic space, 

41 

the bio-therapeutic space, the unpredictability at the FDA seems to 

be a problem? 

Dr. Crosse, would that help? 

Ms. CROSSE. You know, that is not something that we heard from 

the manufacturers—— 

Mrs. BLACKBURN. OK. 

Ms. CROSSE [continuing]. Particularly. I think that, you know, 

certainly that is always an issue in any review process for the applications, but it is not something that they particularly pointed to 

here, because of the unpredictability of when a shortage might 

occur. 

Mrs. BLACKBURN. OK. 

Dr. Throckmorton? 

Mr. THROCKMORTON. I want to try to draw a distinction between 

the numbers of ongoing shortages, those that last extended periods 

of time, which are important—and that is one group of shortages 

that I think we know less about than we need to, I think that is 

a group that bears additional exploration—and the numbers of new 

shortages and the numbers of new shortages prevented. So when 

I answered your question that there are too many shortages, I— 

there are too many shortages because they are shortages that impact on human access to drugs in the U.S. I mean, that is— 

Mrs. BLACKBURN. Sure. 

Mr. THROCKMORTON [continuing]. We would have to do away 

with those before there would not be too many shortages. 

Having said that, however, I think we have to acknowledge that 

there has been work that has been important, that has been able 

to prevent new shortages from adding onto that pile, if you were. 

We are able to prevent shortages that matter. Our next important 

task, a task that I think we need to undertake, is to understand 

those longer duration shortages, those shortages that mean no 

product is in the marketplace at all; there is no manufacturer willing and interested in manufacturing the product. 

Mrs. BLACKBURN. My time has expired. I thank you for that additional explanation. 

Mr. Chairman, as I yield back to you, I do want to take a moment and wish happy birthday to Congressman Guthrie. 

Yield back. 

Mr. PITTS. The Chair thanks the gentlelady and, well—— 

Mr. GUTHRIE. You didn’t say which birthday. 

Mr. PITTS [continuing]. Wishes Mr. Guthrie a happy birthday. 

At this time, the Chair recognizes the ranking member emeritus 

of the full committee, Mr. Dingell, 5 minutes for questions. 

Mr. DINGELL. Mr. Chairman, I thank you for your courtesy and 

for holding this important hearing. I am pleased the committee is 

turning again to the important topic of drug shortages. There are 

many causes for this: the availability of raw materials, complexity 

of manufacturing, certain treatments, sudden increases in demand. 

We have also got a significant problem in adequate funding for 

FDA and an adequate number of personnel to properly address the 

business of that Agency. While we have made some progress in this 

area, such as the passage of the FDA Safety and Innovation Act, 

which improved communication and reporting of drug shortages, 

42 

we all agree, I think, that there is more work to be done. So I hope 

our witnesses will answer the questions yes or no. 

Dr. Throckmorton, the last time this committee held a hearing 

on drug shortages, the situation was dire. Is it correct that the 

number of new drug shortages quadrupled from 2005 to 2011, yes 

or no? 

Mr. THROCKMORTON. Yes. 

Mr. DINGELL. Now, Doctor, is it correct that there are only 44 

new drug shortages in 2013 compared with 117 during the year 

2012, yes or no? 

Mr. THROCKMORTON. Yes. 

Mr. DINGELL. Now, Doctor, is it correct that FDA successfully 

prevented 170 drug shortages in 2013, yes or no? 

Mr. THROCKMORTON. Working with manufacturers, yes. 

Mr. DINGELL. Now, Dr. Crosse, although GAO used slightly different metrics, did your Agency also find a decrease in new drug 

shortages during 2012, yes or no? 

Ms. CROSSE. Yes. 

Mr. DINGELL. Dr. Throckmorton, did the new authorities provided in the—to the Agency in FDASIA help FDA to reduce the 

number of new drug shortages, yes or no? 

Mr. THROCKMORTON. Yes. 

Mr. DINGELL. Would you submit for the record additional 

changes that need to be made to further reduce the delays and the 

shortages when they occur? 

Mr. THROCKMORTON. Yes. 

Mr. DINGELL. I also would like to know, would more personnel 

and more money assist FDA in terms of addressing these questions? 

Mr. THROCKMORTON. We are devoting resources we need to this 

problem. 

Mr. DINGELL. And so, Doctor, would you submit us a short monograph on that—— 

Mr. THROCKMORTON. Yes. 

Mr. DINGELL [continuing]. To assist the committee? 

Dr. Throckmorton, does FDA need additional authorities to help 

combat both existing and future drug shortages, yes or no? 

Mr. THROCKMORTON. Existing authorities are providing us important tools. 

Mr. DINGELL. Would you please submit a detailed response to the 

record, including the resources needed by the Agency? 

Mr. THROCKMORTON. Yes. 

Mr. DINGELL. Dr. Crosse, GAO’s report on drug shortages makes 

two recommendations to FDA. Specifically, you recommend that 

the Agency use its drug shortage database in a more proactive 

manner to identify trends and patterns to help prevent shortages 

before they occur. Is that correct? 

Ms. CROSSE. Yes. 

Mr. DINGELL. Now, Dr. Throckmorton, does FDA agree with this 

recommendation? 

Mr. THROCKMORTON. Yes. 

Mr. DINGELL. Would you please both submit a detailed response 

for the record regarding how FDA could use this database more 

43 

proactively and whether you need more resources to implement the 

recommendations? 

Mr. THROCKMORTON. Yes. 

Ms. CROSSE. Yes. 

Mr. DINGELL. Now, I am pleased with the progress made in preventing drug shortages since the passage of FDASIA. We need to 

take a step back and look at the big picture. Fundamentally, drugs 

are in shortage because we simply aren’t making enough of them. 

As you know, many current shortages are of generic sterile 

injectable drugs. 

Dr. Throckmorton, does FDA believe there is sufficient incentives 

to enter this market today, or are more needed? 

Mr. THROCKMORTON. Important question. I can’t answer it without a fuller discussion with other stakeholders. 

Mr. DINGELL. Would you submit a proper analysis, then, in response to this? 

Mr. THROCKMORTON. Yes. 

Mr. DINGELL. Now, I think it is time to start thinking outside the 

box about how we can continue to make progress on preventing 

these drug shortages and combating existing shortages. We need 

new and new innovative ideas to help solve the problem as well as 

cooperation from all stakeholders. I look forward to working with 

my colleagues on the committee, the FDA and all stakeholders on 

this critical issue moving forward. 

Mr. Chairman, I thank you and I yield back the balance of my 

time. 

Mr. PITTS. The Chair thanks the gentleman. 

Now yields 5 minutes to the vice chairman of the subcommittee, 

Dr. Burgess, for questions. 

Mr. BURGESS. Thank you, Mr. Chairman. 

Dr. Throckmorton, you know, we had the Executive order from 

October of 2011 and then, of course, Food and Drug reauthorization 

in July of 2012, but for the casual observer to this problem of drug 

shortages, can you kind of just give us a thumbnail of what is 

being done to deal with the existing drug shortages? 

Mr. THROCKMORTON. We have a number of things. First off, I 

would say existing drug shortages, especially those that have lasted 

for a prolonged period of time, are hard. They are hard to resolve, 

because the factors that have led to them have meant manufacturers have left that space entirely, so resolving those is going to require finding tools to encourage a new manufacturer to decide to 

add a product to a manufacturing line, make a decision that that 

is a product that they can make a profit at, decide to design that 

line and get approvals and things. So that—those long-term shortages are things I think we need to explore further than we have 

to date to now. 

Mr. BURGESS. Hold that thought for just a second. Let me just 

ask you, have the manufacturers been responsive? 

Mr. THROCKMORTON. Manufacturers understand this issue. We 

have been in close discussion with many of the manufacturing organizations, ISPE and PDA and other groups. They have identified 

this group, these groups of longer-term shortages as things that we 

need to continue to talk about, absolutely. 

44 

Mr. BURGESS. You know, Dr. Crosse talked about enforcement 

discretion and you talked about exercise of regulatory flexibility. 

Can you give us some practical examples of where that exercise of 

regulatory flexibility—I mean, for example, the anesthetic drug 

propofol, has there been any? Is there anywhere where regulatory 

flexibility may help in that particular shortage? 

Mr. THROCKMORTON. Let me give you a slightly different example, and then we can return to propofol if it isn’t useful, but let’s 

talk about total parenteral nutrition, or the nutritional supplements that were in critical shortage recently that are used in newborn infants, where it is just really life or death for them to be able 

to get access to these medicines. 

Those products were in limited availability because the manufacturers are having a hard time producing enough sufficient materials. FDA expedited any and every review, expedited all of our 

inspectional activities to make certain that whatever the manufacturer was able to provide, we were able to make certain was available to serve the infants, the newborns as quickly as possible. 

We have had other examples where particulates have been 

found, examples of drugs in shortage where particulates have on 

surface required cessation of manufacture, cessation of distribution 

of the product. Because of their critical nature, we worked with the 

manufacturers, we have worked to find filters that could be placed 

in line when that product is administered to the patient, allowing 

them to continue to be used. Even though that there is this product 

defect, these particulates that exist, we have determined they have 

to be made available to the patients, we have worked with the 

manufacturers to make that happen. So—— 

Mr. BURGESS. And so that has been successful. Talk about 

propofol, though, because I get a lot of questions about that. I 

mean, lack of an anesthetic, a reliable, safe anesthetic drug is a— 

I mean, it is a big deal. 

Mr. THROCKMORTON. Absolutely. And propofol’s a slightly different situation, because there the issue is a large fraction of the 

propofol comes from outside the U.S. Well over 90 percent of the 

propofol is imported into the country, and there have been some 

concerns about importation as—because of some use of propofol in 

unapproved uses. 

The FDA’s interest, the focus that we have had, has been to 

make certain that the propofol is available for patients who are 

using it on label as indicated, as you said, in outpatient settings 

for anesthesia and those things. So our work there has been to 

work with the sponsor to do anything we needed to make sure the 

patients received it when it was indicated for them; 5 million units, 

dosages a month or something, it is an enormously important product that we are paying very close attention to. 

Mr. BURGESS. Well, and it has revolutionized outpatient surgery 

because the recovery time is so abbreviated with that as opposed 

to the other compounds that were previously available in days gone 

by. 

Mr. THROCKMORTON. Absolutely. And we know that when in the 

past, there was a propofol shortage a few years ago, and what we 

learned in that shortage was that when physicians moved from 

propofol to other products that they were less familiar with, you 

45 

know, mistakes occurred, because they were not as familiar with 

the dosage and how to monitor patients and things like that. So 

making certain that that product is available is something that is 

very important for the U.S. 

Mr. BURGESS. Just very briefly, I have heard anecdotally that 

difficulties getting proper amounts of Tamiflu during this last flu 

season and that the cost for Tamiflu had really exponentially increased. Can you speak to that at all? 

Mr. THROCKMORTON. I haven’t heard that the cost of Tamiflu has 

spiked. There are other increases in pricing that we have been 

hearing about, although that is not something that the FDA normally, you know, has the statutory authority over. And while there 

were some spot shortages with Tamiflu, we think at present we are 

able to produce the needed—the necessary amounts of Tamiflu necessary. 

Mr. BURGESS. Thanks, Mr. Chairman. 

I have some additional questions I will submit in writing, but I 

thank you for the courtesy. 

Mr. PITTS. The Chair thanks the gentleman. 

Now recognize the gentlelady from Virgin Islands, Dr. 

Christensen, for 5 minutes for questions. 

Ms. CHRISTENSEN. Thanks, Mr. Chairman. And I want to thank 

you and the ranking member for this hearing today. 

While I am very happy to hear that the drug shortages are reducing, as everyone has said, they still remain too high, and we 

know that rural areas, communities of color, territories like my district will be some of those where we will feel it the most when 

there is a drug shortage. 

I have a question that sort of digs a little deeper into my colleague from Tennessee, the vice chair’s question, I think. And I am 

asking both—I will start with Dr. Throckmorton, but also ask Dr. 

Crosse to comment. One of the explanations I have heard for the 

increase in drug shortages was that FDA was forcing manufacturers to come up with the state-of-the-art manufacturing practices, 

even though the old tried and true were completely adequate to ensure safety and effectiveness. The argument went that to meet the 

new standards, some companies had to shut down their lines to upgrade their facilities, resulting in the shortages. 

I have also heard something that is almost the opposite argument, that FDA had been telling some companies for years that 

their facilities were in decline and needed to be upgraded to avoid 

problems in the future, even though the facilities were currently 

meeting inspection standards, and eventually, those warnings, unfortunately, came through. 

So, Dr. Throckmorton, can you comment on these two different 

perspectives? You mentioned in your testimony that FDA is trying 

to encourage industry to adopt new technologies but, at the same 

time, that FDA is not raising the bar, is not raising the bar on 

standards for existing appropriate technologies. That seems a very 

nuanced point. Could you just elaborate for me? 

Mr. THROCKMORTON. Absolutely. So there are a set of standards 

that are in place right now for manufacturing, for sort of quality 

manufacturing that we would expect a firm that is making 

propofol, a firm that is making a tablet form, whatever, a set of 

46 

standards that they have in place that would guide, you know, the 

manufacture of a product so that it is sufficiently safe and efficacious in quality manufacturing. Those things are working, and we 

are not changing those standards at all. 

What we also see is that there are more efficient ways to be 

manufacturing products, especially products that are very complicated, products that are like sterile injectables or products that 

are biologics, places where you want to use the state-of-the-art 

manufacturing processes. We have been working for over a decade 

now trying to identify those manufacturing processes to help guide 

drug manufacturing and then make recommendations in the form 

of guidance in ways that manufacturers can look at to do better 

than the current. 

So we are not looking to change the current acceptable process 

practices; we are looking to find a way to incentivize a move toward 

a more efficient, a more continuous kind of manufacturing that we 

think offers a lot of potential for preventing shortages by improving 

the overall quality of manufacturing. 

Ms. CHRISTENSEN. Thank you. 

Dr. Crosse, would you like to add anything? 

Ms. CROSSE. Well, we too heard from industry these—the same 

concerns and from FDA the same response. You know, FDA has 

moved increasingly and, now under FDASIA, explicitly is moving 

to a risk-based inspection decisionmaking process about which 

manufacturers they should be inspecting with which frequency. 

The drugs that are in shortage, the sterile injectables, are inherently risky in their manufacture, and so you would expect there to 

be a higher level of inspection of those facilities just because of the 

risk of the product. We, as part of the ongoing work I mentioned 

before, we are going to be looking at the pattern of inspections that 

FDA has had across a number of years of these facilities to see if 

we are seeing any change, because it was a concern raised to us 

by manufacturers, but the standards, as posed in regulation and 

guidance, have not changed. 

Ms. CHRISTENSEN. Thank you. I have a number of other questions that I will submit for the record, but I have a short one. 

Dr. Crosse, the GAO report doesn’t focus on shortages of medically important drugs. Can you tell us how closely the shortage 

characteristics and trends provided in the report are likely to track 

with or predict those from medically important drugs? Is that 

something you can focus on in the future? 

Ms. CROSSE. We are very—it tracks very closely. We did use a 

different data source. We used information from the University of 

Utah Drug Information Service, because they have had a database 

for much longer, and so we were able to look at trends across time. 

FDA didn’t develop its database until 2011, and we wanted data 

that would go back to 2007. But the majority, the vast majority of 

the data that Utah posts are of medically necessary drugs. There 

is a very close alignment there. There are some differences in the 

way the two—that FDA and Utah count the drugs, so the numbers 

may look different even though you are talking about the same 

drug shortage. 

Ms. CHRISTENSEN. And my time is up, so, thank you, Mr. Chairman. 

47 

Mr. PITTS. The Chair thanks the gentlelady. 

Now recognize the gentleman from Illinois, Mr. Shimkus, 5 minutes for questions. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

Thank you for being here. And obviously, a follow up to the GAO 

report. A few comments before I begin. You know, we are never 

going to have enough money to do whatever we want to do, and 

more people and more money, sometimes it is just assumed that is 

going to make things better, but this really—it is important for me 

to always remember the whole budget pie. When 65 percent is 

mandatory spending, 35 percent is discretionary spending, if we 

don’t get control of our mandatory spending, spending stays the 

same, discretionary keeps shrinking, which will affect all agencies, 

the military and the like. 

And so, in this budget debate, as people say, and we hear the discretionary part of the budget, it—we are ill-advised not to always 

talk about the problems of mandatory spending. 

I would also say that FDA was one of the few agencies that got 

additional money through these budgetary fights than a lot of other 

agencies. 

So, with that, Sydne, can you put up this—because a lot of the 

questions, I think, are pertaining to this that is in the GAO report. 

And I have it on—that is why I have been playing around with my 

iPad, trying to figure out everything that this chart says, but I 

think it is very illustrative, whether it is Marsha Blackburn or 

John Dingell, I think they have all been referring to this chart. 

And the dark blue is ongoing shortages which began in prior years. 

[The chart follows:] 

48 

49 

Mr. SHIMKUS. Now, I guess the first question I have is, so like 

in the 2000, you have 40. Those don’t always carry—some of those 

must fall off. Is that true? 

Ms. CROSSE. Yes, that is—that is true. It is not the same—— 

Mr. SHIMKUS. Cumulative. 

Ms. CROSSE. It is not cumulative of all of them. Some drug shortages are resolved, and so they drop out. Those that have not been 

resolved by the end of the year roll over into our data for the next 

year. 

Mr. SHIMKUS. And forgive me if I didn’t read the report as closely 

as I should have, from 2007, even until what is projected on the 

final bar chart, which isn’t finished with the fiscal year, are there 

pending drugs that follow that whole time period? 

Ms. CROSSE. There—I am not aware of any that followed the entire time period. We do have some that have extended for 5 years, 

a very small number. Most drug shortages are resolved within 1 

year or 2 years, but there are a very small number of shortages 

that have continued across multiple years. 

Mr. SHIMKUS. Thank you. Now—and so then the lighter blue portion is really kind of, Dr. Throckmorton, that is what you have 

been referring to, is that success has been made in the new shortages, right? So—and we see that on this chart. 

And that is—Dr. Crosse, you have concurred with that, too. 

There is some—there is progress being made on that, as we can see 

from that pending chart. Correct? And that is both in the testimony. 

Ms. CROSSE. Yes. Yes, that is correct. 

Mr. SHIMKUS. So I guess the—so that is my kind of summation. 

I think this chart is very illustrative in the report and kind of highlighted what most people had talked about. 

I guess the—a couple years ago, when we have been having these 

debates, I always wondered why the market itself doesn’t respond 

to alleviate these shortages based upon a price signal. Now, there— 

Dr. Burgess kind of mentioned, which Dr. Throckmorton, you may 

have dismissed that there was a Tamiflu signal sent. I don’t know 

that. You said you didn’t know that. Why, in my minute left, is 

there something structurally about how we, either the government 

in its coding or its spending through Medicare and Medicaid or the 

insurance applications of purchasing drugs, is there something that 

distorts the market signals for shortages? 

Ms. CROSSE. I am not sure. You know, we didn’t really look at 

it that way. 

Mr. SHIMKUS. That is fair. Maybe that is something, Mr. Chairman, to follow up with in another question in the future. 

Dr. Throckmorton, what do you think? 

Mr. THROCKMORTON. I think, as others have commented, economics have got to be playing a role in the decisions that the manufacturers are making here. I think we know less about that, at least 

speaking for myself, speaking for the FDA, than we might like to, 

but those are important—— 

Mr. SHIMKUS. A lot of these shortages are low-margin generic 

drugs, too, so if they are very low margin, they are making a penny 

on whatever the application is. And that is hard to get a price sigVerDate Mar 15 2010 10:04 Sep 30, 2014 Jkt 037690 PO 00000 Frm 00053 Fmt 6633 Sfmt 6633 F:\113-117 DRUG SHORTAGES OK TO PRINT\113-117 DRUG SHORTAGES PDF MADE
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nal on a return on a major if you only have one plan operating full 

speed producing all this product. 

Mr. THROCKMORTON. Dr. Burgess’ propofol—others would remember better—someone has said that the profit on a dose is in 

the tens of cents. 

Mr. SHIMKUS. Yes, great. Excellent. 

Thank you very much. Mr. Chairman, I yield back. 

Mr. PITTS. Chair thanks the gentleman. 

Now recognize the gentleman from Kentucky, Mr. Guthrie. Five 

minutes for your question. 

Mr. GUTHRIE. Thanks. I appreciate what the gentleman from Illinois is asking because I had a kind of high school reunion with 

some friends. A friend of mine is an emergency room physician in 

Auburn, Alabama, and he was telling me about the shortage of 

drugs. And he said it wasn’t the expensive stuff. And he couldn’t 

do his service properly sometimes because of that. And, you know, 

classic price controls in economics—I am not saying there are price 

controls, but when there is not ability to move the price for some 

reason, it is something to investigate—then you would say it is 

going to be a shortage in quality. That is the two things you mentioned is shortage of ability and quality, and it seems there is not 

a price signal, that the gentleman from Illinois, to allow other people to enter. 

We are not talking about even hundreds of dollars or thousands 

of dollars. We are talking about sometimes cents and sometimes 

just dollars, and people aren’t getting over that. 

But, Dr. Crosse, in your testimony, you noted that FDA officials 

have told you that FDASIA’s requirements that manufacturers notify the FDA in advance have helped the situation that they are 

able to take some steps, but you also note that while FDA is planning to establish a new information system to track data, there are 

significant concerns, specifically that they are not conducting routine analysis of existing data, drug shortages in the database to 

identify or respond proactively. Can you elaborate, or will you 

elaborate on what—— 

Ms. CROSSE. Yes. Well, we did have concerns about what we call 

internal controls, the extent to which FDA was ensuring the accuracy of the information in their database and then the extent to 

which they were doing broader analyses to look at such things as 

the ongoing shortages, as opposed to using it as a tool to help them 

track the status of an individual shortage. So what we weren’t seeing were those kinds of larger analyses looking at trends. And as 

time goes on and they have more fully developed data, we believe 

it is important for them to engage in that. And they have agreed 

with us that that is something that they plan to start doing now 

that they have a little more data for a little longer period of time, 

that that is something that they can do. 

But, you know, we do talk a little bit, to your earlier point, about 

the, kind of, the economics. That is part of what we are trying to 

continue to look at. There have been issues raised to us but no 

agreement on whether or not there is any one source of what is 

holding down those prices. 

Mr. GUTHRIE. OK. Thanks. And so also I noticed, in 2011, inspections were at their peak. FDA inspections were at their peak, and 

51 

also the shortages were at their peak. Has GAO examined the correlation between inspections and drug shortages? 

Ms. CROSSE. We haven’t. And that is also part of what we are 

going to continue to look at, is to go and see if there was a change 

across time in inspections. But as I noted before, these are highrisk products for the most part. Most of these are the sterile 

injectable drugs, and they are high-risk products where you would 

expect FDA to be going with some greater frequency to those facilities than to someplace that is making, you know, a tablet that has 

been in operation for a long time with a good safety record. 

Mr. GUTHRIE. And then, Dr. Throckmorton, drug shortages often 

require practitioners to utilize alternative treatments that may not 

be as effective. Does the FDA compile and disseminate information 

regarding alternative treatments in times of shortage for practitioners or patients? 

Mr. THROCKMORTON. We have typically left that to other groups, 

particularly the pharmacists and ASHP, for instance, with their 

Web site that Dr. Crosse has been using for her data and things, 

do identify alternative uses. We are able to identify other drugs 

with the same indication, but we recognize the practice of medicine 

is such that people look for other alternative therapies that may or 

may not be on label, and so we tend to use the other—where we 

take advantage of other people’s expertise to have them do that for 

us. 

Mr. GUTHRIE. Can GAO provide more detail about FDA’s regulatory actions to prevent or mitigate drug shortages based on your 

discussions with Agency staff as well as manufacturers? And bottom line, are FDA’s actions or decisions being exercised consistently? 

Ms. CROSSE. I don’t know that I can speak to whether they are 

be exercised consistently. We certainly can provide you with some 

additional detail on what actions they have taken. 

Mr. GUTHRIE. Mr. Chairman, I yield back. 

Mr. PITTS. The Chair thanks the gentleman. 

I now recognize the gentleman from Virginia, Mr. Griffith, for 5 

minutes. 

Mr. GRIFFITH. Thank you, Mr. Chairman. I appreciate. 

Thank you all for being here today and answering these questions. 

I would be remiss to not remind everybody that drug shortages, 

particularly of sterile injectables, led to some health care providers 

feeling dependent on the supposedly sterile compounded drugs that 

ultimately led to the fungal meningitis outbreak in 2012 that killed 

64 Americans, including two in my area. 

Because these drugs were more difficult to obtain, illegal manufacturers that called themselves compounding pharmacies, like 

NECC, entered the market to fill the need of hospitals and outpatient clinics for sterile injectables. 

Thankfully Congress put the FDA on notice with FDASIA to deal 

with the drug shortages, much like Congress did with the Drug 

Quality and Security Act with large-scale compounding and illegal 

manufacturing. 

52 

FDA officials have signalled that the Agency has begun to identify signals to better predict quality issues at manufacturing facilities. 

Dr. Throckmorton, can you comment on these improvements? 

Mr. THROCKMORTON. Mostly to say that we understand the importance of getting that right, so identifying what those metrics are 

and then having a discussion about how they would be used is very 

important. And so part of our ongoing efforts, efforts this coming 

year and beyond, are to speak with manufacturing experts that can 

talk about the kinds of measures that a plant uses to follow their 

own manufacturing quality, understand those things better, and 

then talk about how a purchaser might make use of those kinds 

of information. 

Mr. GRIFFITH. And I appreciate that, and one of the concerns 

that I had was that it appeared in that fungal meningitis outbreak 

that the lawyers at FDA were not using all the powers that were 

available to them to oversee. And while we don’t want too much 

oversight that stops manufacturers who are doing the right things 

from producing their product, I am hopeful that the lawyers are 

being more aggressive if they see something that looks like it is out 

of line, because while we want to have a good supply, we want to 

have a safe supply as well. Would you not agree with that, and do 

you think the lawyers are being a little more aggressive post the 

outbreak of the fungal meningitis problem? 

Mr. THROCKMORTON. I would absolutely agree we need to do anything we can to assure a safe supply. 

Mr. GRIFFITH. All right. 

Dr. Crosse, GAO recommended that the FDA improve its databases so the Agency can employ more predictive analyses to its preventative activities. How did the Agency respond to this critique, 

and how far off are they from putting your recommendations into 

practice? 

Ms. CROSSE. FDA agreed with our recommendations, and my understanding is they are beginning to do it immediately. 

Mr. GRIFFITH. All right. Also, the GAO report found that the 

FDA lacked policies, procedures and specific training materials related to management and use of its existing drug shortage database. What impact does this have on the Agency’s ability to use 

this database to prevent or mitigate shortages? 

Ms. CROSSE. Well, we think they do need to have these kind of 

standard procedures in place to assure the accuracy of the data and 

the understanding on the part of their staff of exactly how data 

should be entered and how it should be analyzed. They also agreed 

that they would move forward on those steps. 

Mr. GRIFFITH. I appreciate it. What role do you think this database could play in addressing future drug shortages? 

Ms. CROSSE. Well, we think it is important for the Agency to 

have good information because they need to be able to look at this 

more broadly, to look within classes, to look across time to see, to 

be able to measure whether or not they are putting the right steps 

in place and having the kind of impact to improve the situation 

rather than treating these as each individual kind of situation that 

has to uniquely be solved. 

Mr. GRIFFITH. I appreciate it. Thank you very much. 

53 

With that, Mr. Chairman, I yield back. 

Mr. PITTS. Chair thanks the gentleman. 

I now recognize the gentlelady from North Carolina, Ms. Ellmers. 

Five minutes for questions. 

Mrs. ELLMERS. Thank you, Mr. Chairman, and thank you to our 

panel for being here today. In my district, this is a very specific situation and I am hearing from all of my hospitals. In particular, I 

will focus on Wake Med Hospital System. They are an 870-bed 

health care system with multiple facilities around Raleigh, North 

Carolina. They basically deal with the three primary vendors for IV 

infusions. And all three have experienced quality manufacturing 

issues as well as holiday production shutdowns that contributed to 

the shortage. Wake Med’s pharmacy spent an additional $80,000 in 

January to stock up on the drugs in anticipation. 

I appreciate the efforts of the FDA to address the shortage, but 

it appears that they are only addressing the symptoms and not the 

real causes. 

I am also concerned about the Medicare reimbursement system, 

especially the explosion of the 340(b) discounts, which is reducing 

margins for generic manufacturers. This is pushing them to stop 

producing low-cost generic injectables, just like the system is driving community cancer clinics into hospitals. It also appears that 

these manufacturers simply don’t have the margins to invest in 

their manufacturing plans, which is why we see many of the quality problems. 

My question has to do with what is and how are we addressing 

these issues right now. I want to focus my questions today on the 

FDA’s work with the industry to make sure everyone is working together to find solutions. 

Dr. Throckmorton, there remains virtually no transparency in 

the process for how drugs that make it onto the shortage list ultimately get off this list. How does the Agency decide that a product 

is no longer in shortage, and is there a consistent and standardized 

formula for FDA uses to produce a product from the shortage list? 

Mr. THROCKMORTON. The short answer is, yes, we do have a consistent process that we use to apply to drugs to decide when they 

come onto the shortage list and when a shortage is no longer existing and they can come off. 

Our focus is on determining whether or not patients in the U.S. 

can get the treatments that they need. So it is not focused on product-by-product shortage, so there may be a shortage of a buffered 

aspirin because one manufacturer of a kind of buffered aspirin may 

no longer be manufacturing. But there may be four other kinds of 

aspirin that are available. That will not be a shortage from our perspective because the other products can and will ramp up. That is 

something our people know about, talk with those other manufacturers, were able to assess using prescription data, using other 

data that we have access to; we can determine whether those other 

manufacturers can fill in for that manufacturer that has made a 

decision to not manufacture or needed to stop manufacturing to improve a plant or improve a product line. 

That is slightly different than the kinds of data that the University of Utah counts, the data that Dr. Crosse is referring to. We are 

looking at the totality of the data, the availability of a given therVerDate Mar 15 2010 10:04 Sep 30, 2014 Jkt 037690 PO 00000 Frm 00057 Fmt 6633 Sfmt 6633 F:\113-117 DRUG SHORTAGES OK TO PRINT\113-117 DRUG SHORTAGES PDF MADE
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apy, not an individual product. And so our numbers are slightly 

different than ASHP that the University of Utah have. 

We believe fundamentally ours reflect the availability of the therapy for the patients, which is our public health goal, if you will. 

But behind that, we have a process in place to determine when 

available production is not able to meet demand and then work 

with manufacturers, and when production returns and is once 

again able to meet demand, to take something off of the shortage 

list. 

Mrs. ELLMERS. OK. 

Also, very specifically, there again, Dr. Throckmorton, the FDA’s 

inspection of API can remain a barrier and ANDA holder can market the generic drug. How has the Agency tried to improve its 

record on this issue to ensure that the ANDA holders can market 

a drug and potentially address a drug shortage? 

Mr. THROCKMORTON. Two parts to that answer. The first part 

would be some of the actions that we have already talked about, 

the expedited reviews and some of the expedited inspections that 

the FDA is being able to do, particularly in shortage situations. 

There is a second longer term, and it relates to the passage of 

GDUFA. So the Generic Drug User Fee Act has provided us additional resources and additional opportunity to sort of balance the 

playing field, if you will, so that we are able to devote the resources 

we need to the generics market, which—85 percent of the U.S. drug 

market is generics now. We are able to allocate the resources that 

we need to that area to make certain they are getting the 

inspectional attention, the compliance history, the reviews from our 

reviewers that they need to, so that is an important addition for 

us. 

Mrs. ELLMERS. Thank you so much. 

And I see my time is expired. Thank you, Mr. Chairman. 

Mr. PITTS. Chair thanks of the gentlelady. 

That concludes the questions of the members who are present. 

We will have additional questions we will send to you in writing. 

If you would please respond promptly. 

I remind members that they have 10 business days to submit 

questions for the record, and members should submit their questions by the close of business on Tuesday, February 25. Thank you 

very much for the testimony, the good information, and we look forward to continued work with you. 

With that, without objection, the subcommittee is adjourned. 

[Whereupon, at 3:15 p.m., the subcommittee was adjourned.] 

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