Testimony Before the United States House of Representatives 
Committee on Appropriations 
Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and 
Related Agencies 
 
 
 
 
Hearing Title: Budget/Oversight:  
Health and Human Services Office of Inspector General 
Testimony on: Oversight of the Food and Drug Administration  
Suzanne Murrin 
Deputy Inspector General  
Office of Evaluation and Inspections 
Office of Inspector General  
Department of Health and Human Services 
February 27, 2020, 11 a.m. 
Location: Rayburn House Office Building, Room 2362-A 
 
 
 
 
           
 
Testimony of: 
Suzanne Murrin 
Deputy Inspector General for Evaluation and Inspections 
   Office of Inspector General, Department of Health and Human Services 
 
Thank you, Chairman Bishop, Ranking Member Fortenberry, and distinguished Members 
of the Subcommittee.  I am Suzanne Murrin, Deputy Inspector General for Evaluation and 
Inspections in the Office of Inspector General (OIG) of the Department of Health and Human 
Services (HHS or Department).  Thank you for the opportunity to discuss OIGs oversight of the 
Food and Drug Administration (FDA).  We are grateful for the support this subcommittee has 
provided to OIG, which has allowed us to expand our oversight of FDAs vital programs.  
OIG has long recognized the importance of overseeing FDAs efforts to protect the 
public by ensuring the safety, efficacy, and security of human and veterinary drugs, biological 
products, and medical devices; ensuring the safety of our nations food supply; and regulating 
tobacco products.  With an annual budget of approximately $6 billion, FDA oversees the safety 
of products that represent about 20 percent of all U.S. consumer spending.  
Since fiscal year (FY) 2015, thanks to the additional resources ($1.5 million annually) 
that this subcommittee has directed be transferred to OIG, we have enhanced our oversight of 
FDA.  We have pursued a four-part strategy: (1) provide useful, relevant information, analysis 
and enforcement; (2) drive positive change by working with FDA to implement our 
recommended improvements; (3) build OIG expertise in FDA programs; and (4) 
comprehensively analyze the risks confronting FDA programs to make strategic, risk-based 
decisions on the priority areas we should pursue.     
Our work primarily focuses on how FDA could keep Americans safer by more 
effectively regulating the food supply, medical devices, and drug products.  Through this work, 
OIG has driven meaningful improvements in the efficiency and effectiveness of FDAs oversight 
and enforcement in many ways.  For example, a number of the improvements in the Food Safety 
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Modernization Act (FSMA) addressed OIG recommendations to improve the traceability of the 
food supply and the accuracy of the food facility registry, after we reported that selected food 
products could not be traced through the food supply chain, from a retail shelf back to a farm, 
and almost half of the facilities (i.e., processors, packers, manufacturers, and holders) we 
contacted failed to properly register with FDA.1  These improvements strengthen FDAs ability 
to quickly locate facilities during an outbreak of foodborne illness, bioterrorism, or economically 
motivated adulteration.  
This testimony explores the improvements that FDA has made in response to OIG 
recommendations to improve the safety of food, medical devices, and drugs.  The testimony also 
highlights critical OIG recommendations that FDA has yet to implement, where we continue to 
engage with FDA leadership and staff.  Finally, we discuss areas where OIG is expanding our 
oversight, such as FDA regulation of tobacco products, efforts to combat the opioid crisis, and 
fostering drug competition.   
 
OIG Has Identified Vulnerabilities in FDAs Efforts To Protect Our Nations Food Supply  
For over a decade, OIG has examined FDAs efforts to protect our Nations food supply.  
An estimated 1 in 6 Americans get sick from contaminated foods each year, with more than 
128,000 hospitalizations and 3,000 deaths.  Foodborne illnesses are largely preventable, and the 
American public relies on FDA to ensure the safety of the food in the global supply chain for 
both human and animal food.2  Our work has highlighted vulnerabilities in FDAs prevention 
efforts and its ability to respond effectively when problems are identified.  Most recently, OIG 
has found vulnerabilities in FDA inspections of food facilities and FDA oversight of food recalls.  
FDA Needs To Ensure Routine Inspection of Food Facilities and Prompt Correction of 
Violations.  FSMA established specific mandates governing the timeliness of food facility 
                                                           
1 Traceability in the Food Supply Chain, OEI-02-06-00210, March 2009.  
2 FDA regulates over 80 percent of the U.S. food supply, including dairy, seafood, produce, packaged foods, bottled water, and 
some egg products.  The U.S. Department of Agriculture (USDA) regulates meat, poultry, and eggs. 
 
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inspections.  OIG has reviewed the frequency of FDAs inspections and FDAs ability to take 
swift and effective action when inspections identified problems3.  OIG found that the overall 
number of food facilities inspected by FDA had decreased over time and raised concerns about 
FDAs ability to meet FSMAs tighter inspection mandates, despite successes meeting the initial, 
more generous inspection mandates.  Moreover, FDA did not always take timely actions to 
ensure that facilities corrected the most significant inspection violations.  When FDA did take 
action, it commonly relied on facilities to voluntarily correct the violations.  In fact, FDA rarely 
took advantage of the new administrative tools provided by FSMA, such as the administrative 
detention of food or mandatory food recalls.  
OIG made four recommendations to FDA to address the vulnerabilities identified in this 
report: (1) improve its stewardship of the inspections program to ensure the better use of 
resources, (2) take appropriate action against all facilities with significant inspection violations, 
(3) improve the timeliness of its actions so that facilities do not continue to operate under 
harmful conditions, and (4) conduct timely followup inspections to ensure that significant 
inspection violations are corrected.  FDA concurred with these recommendations and stated that 
it has taken steps to address them, including developing an FDA Management Dashboard that 
may implement certain aspects of our recommendation to follow up on inspection violations.  
OIG continues to monitor FDAs ongoing response to these four open recommendations as well 
as an earlier recommendation for FDA to seek statutory authority to impose civil monetary 
penalties on food facilities.    
OIG has also reviewed FDAs oversight of State contractors that conduct more than half 
of all FDA inspections4.  We found that in eight States, FDA failed to ensure completion of the 
required number of inspections.  In addition, when States were responsible for correcting 
violations, FDA was not always informed about actions taken, and FDA was unable to determine 
                                                           
3 Challenges Remain in FDAs Inspections of Domestic Food Facilities, OEI-02-14-00420, September 2017.  
4 FDA Oversight of State Food Firm Inspections: A Call for Greater Accountability, OEI-01-98-00400, June 2000.  
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that all inspection violations were remedied.  As a result of this review, FDA changed how it 
monitors State contractors to ensure completion of all required inspections.   
FDA Should Fix Deficiencies in Food Recalls.  To review FDAs use of the mandatory 
recall authority it was granted in FSMA to recall certain harmful foods, OIG reviewed 30 food 
recalls.  We found that FDAs food-recall process was not always effective and efficient in 
ensuring the safety of the Nations food supply.5  Specifically, we identified deficiencies in 
FDAs oversight and monitoring of (1) recall initiation, (2) recall implementation, and (3) the 
accuracy of the recall information captured and retained in FDAs electronic Recall Enterprise 
System (RES).  To better ensure that food recalls are quick and comprehensive, OIG 
recommended that FDA finalize its interim mandatory recall procedures and consider issuing 
guidance for FDA staff on those factors that staff should consider when determining whether 
there is a reasonable probability that a food could cause serious adverse health consequence or 
death.  OIG also recommended steps ranging from specific improvements to FDAs food recall 
plan to establishing performance measures for the amount of time between the date FDA learns 
of a potentially hazardous product and the date a firm initiates a voluntary recall.  Eight of the 
reports 14 recommendations have been implemented and OIG continues to work with FDA to 
seek implementation of the remaining open recommendations, including ensuring that FDA 
monitors food recall performance and refines operating procedures, as needed.   
 
OIG Has Identified Risk Associated With Medical Device Safety and Security  
The speed at which science and technology are evolving means that the development and 
oversight of medical devices presents new safety and effectiveness concerns.  
FDA Needs To Further Mitigate Risk of Cybersecurity Threats to Medical Devices. 
Managing the cybersecurity risks associated with networked devices is an area of increasing 
concern to the OIG as more medical devices use wireless, internet, and network connectivity.  
                                                           
5 Because we selected a judgmental sample, the results are informative about deficiencies in FDAs food-recall oversight process 
but are not representative of the full population of FDA recalls. 
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Researchers have shown that networked medical devices approved by FDA can be susceptible to 
cybersecurity threats, such as ransomware and unauthorized remote access, if the devices lack 
adequate security controls.  These networked devices include hospital-room infusion pumps, 
diagnostic imaging, and pacemakers.  In 2018, OIG released two reports assessing FDAs 
oversight of premarket6 and postmarket7 cybersecurity risks to medical devices.  An underlying 
issue of both reports was the opportunity for FDA to take further action in addressing 
cybersecurity threats to reduce risk to patients and the health care industry.   
In response to these reports, FDA has made administrative changes to its premarket and 
postmarket processes.  Specifically, FDA released draft guidance in 2018 that encourages device 
manufacturers to meet with FDA early and discuss how they are addressing cybersecurity in their 
devices design and development.  FDA also made postmarket improvements to the procedures 
for handling recalls of medical devices vulnerable to cybersecurity threats, including the signing 
of a Memo of Agreement with the Department of Homeland Security to improve information 
sharing of cybersecurity vulnerabilities and coordinate response actions.  We continue to 
recommend that FDA establish written procedures for securely sharing information about 
cybersecurity events with key stakeholders to ensure patient safety.  
FDA Needs To Ensure a Robust Postmarket Surveillance System for Devices.  FDA has 
shifted safety oversight of medical devices to the postmarket setting.  Meanwhile, the number of 
adverse event reports has increased dramatically over time.  Despite the increased reliance on 
and need for a robust postmarket surveillance system, OIG found that manufacturers and medical 
device user facilities often submitted tardy and incomplete adverse event reports.  Further, FDA 
failed to employ adverse event reports in a systemic manner to detect and address safety 
concerns.  Based on our recommendations, FDA took steps to improve its processes for 
reviewing adverse event reports and ensure more timely and complete reporting by 
                                                           
6 FDA Should Further Integrate Its Review of Cybersecurity Into the Premarket Review Process for Medical 
Devices, OEI-09-16-00220, September 2018.  
7 The Food and Drug Administrations Policies and Procedures Should Better Address Postmarket Cybersecurity 
Risk to Medical Devices, A-18-16-30530, October 2018.  
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manufacturers. The Uniform Surveillance System has been operational since 2015, allowing 
FDA to identify manufacturers with late or incomplete reports.  However, OIG continues to 
recommend that FDA build better capacity in their automated systems for managing 
postmarketing requirements and provide a standardized form for annual status reports to ensure 
completion.   
FDAs focus on overseeing the safety of devices in a postmarket setting underscores the 
importance of its surveillance system working well.  Better information allows FDA to monitor 
signals of public health safety concerns and take appropriate action.  It also allows FDA to be 
more targeted in its oversight efforts.  Currently, OIG is examining FDAs evolution from its 
current passive postmarket reporting system to an active surveillance system that FDA believes 
will better protect patients.    
 
OIG Has Identified Safety Concerns With FDA-Regulated Drugs   
OIG has identified vulnerabilities with FDAs oversight of manufacturing and 
distributing drugs as well as particular high-risk drugs such as compounded drugs. 
The Safety of Foreign Manufacturing Is Still a Concern.  According to the FDA, roughly 
40 percent of finished drugs and 80 percent of active drug ingredients are made in more than 150 
countries.  OIG work has determined that FDA made progress on achieving parity in its 
inspections of domestic and foreign generic drug manufacturers.  However, it did not conduct all 
preapproval inspections.  In response, FDA made all of OIGs recommended improvements to 
address its preapproval inspection backlog, improve its ability to track and oversee generic 
manufacturers, and enhance its efficiency in conducting these inspections.   
OIG is now reviewing whether programmatic changes implemented since our first report, 
a program-based management structure that aligns staff by FDA-regulated product, have 
improved FDAs foreign drug manufacturer inspection process. 
Drug Supply Chain Security Is Compromised by Incomplete Drug Tracing Records.  OIG 
has developed a body of work to address safety concerns with potentially dangerous drug 
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products entering the drug supply chain and eventually being dispensed to patients.8  OIG 
investigations have identified instances where Federal programs paid for drugs not approved by 
the FDA, reinforcing the need to be able to trace the path drugs lead from manufacturer to 
patient.     
To protect the drugs in the supply chain, pharmaceutical manufacturers, wholesaler 
distributors, dispensers, and repackagers are required to document each time the legal ownership 
of a drug is transferred from one supply chain trading partner to another.  FDA can use this 
information to identify and investigate potentially harmful drug products and facilitate efficient 
recalls.  OIG work raised concerns about incomplete ownership information that is required on 
wholesale distributors and dispensers documents and a lack of awareness among wholesale 
distributors and dispensers about several drug tracing requirements.   
OIGs work also raised concerns about the inability to trace a drugs physical journey 
through the supply chain.  Although this information is not required in tracing records (records 
only capture changes in legal custody), without this information, there are gaps in the record of 
the drugs path through the supply chain.  The opportunity for harm arises each time a drug 
changes hands, creating opportunities for counterfeiting, tampering, or diversion.  If this 
information was present on tracing information, it could help FDA more quickly identify where a 
drug product may have been compromised, determine where it is located, and then ensure that it 
is removed from the supply chain. 
In response to OIGs recommended improvements, FDA has issued guidance clarifying 
several tracing requirements and has conducted education for dispensers about their obligations 
to exchange tracing information.  OIG continues to follow up with FDA to ensure that it 
addresses concerns about incomplete tracing information and seeks new authority to include 
information about a drugs physical location on tracing records. 
                                                           
8 Drug Supply Chain Security: Wholesalers Exchange Most Tracing Information, OEI-05-14-00640 (September 
2017) and Drug Supply Chain Security: Dispensers Received Most Tracing Information, OEI-05-16-00550 (March 
2018). 
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FDA Should Ensure That Non-Patient-Specific Compounded Drugs Are Obtained From 
Compounders That Meet FDA Quality Standards.  In response to deaths from an outbreak of 
fungal meningitis caused by contaminated compounded injections, Congress enhanced FDAs 
authority over facilities that perform large-scale compounding of non-patient-specific drugs.  
OIG sought to provide FDA with insights to improve its oversight of compounders and enhance 
patient safety by identifying compounders that made non-patient-specific drugs without meeting 
FDA registration requirements.  OIG referred a list of those facilities to FDA, and FDA reported 
using the list to target facilities for inspection.  FDA also reported that some of these inspections 
identified objectionable conditions and some led to a recall.  Overall, OIG determined that 
most hospitals obtained non-patient-specific compounded drugs from outsourcing facilities that 
were registered with FDA and subject to FDA oversight.    
 
OIG Is Expanding Its Oversight To Include Curtailing Youth Tobacco Use, Combating the 
Opioid Crisis, and Fostering Drug Competition  
Youth Tobacco Use.  Tobacco use among youth is at epidemic proportions, driven by a 
dramatic rise in the use of e-cigarettes, even though the use of other forms of tobacco has 
declined.  FDAs retail compliance inspections are a critical tool for FDAs Youth Tobacco 
Prevention Plan to prevent the sale and marketing of all tobacco products to youth.  OIG has 
begun evaluating the extent of these inspections and what can be learned from the results.  We 
are also examining FDAs enforcement of retail tobacco regulations intended to prevent youth 
access to tobacco, including e-cigarettes. 
Combating the Opioid Crisis.  FDA plays a significant role in the national effort to 
combat opioid abuse.  FDA has used Risk Evaluation and Mitigation Strategies (REMSs) as part 
of its comprehensive action plan to reduce the risk of opioid abuse with the overall goal to 
increase the number of prescribers who receive training on pain management and safe 
prescribing of opioid drugs and decrease inappropriate opioid prescribing.  OIG is reviewing the 
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extent to which FDA held drug manufacturers accountable for mitigating the risk of opioid 
misuse and abuse.   
Previous OIG work on the REMS program found that FDA lacked comprehensive data to 
determine whether REMS improve drug safety and recommended that FDA identify REMS that 
are not meeting their goals and take appropriate actions to protect public health.9  
Fostering Drug Competition.  OIG has a long history of work ensuring appropriate 
payment for prescription drugs and has recently expanded our focus to include FDAs efforts to 
foster drug competition as a means to reduce drug spending.  As an initial step, we have begun a 
review that will examine the Orphan Drug status of numerous high-expenditure drugs paid under 
Medicare.  Orphan drug status is granted by FDA as a means to provide financial incentives, 
including market exclusivity, for manufacturers to develop drugs to treat rare diseases.  
However, analysis shows that the actual use and profitability of an orphan drug can be 
considerably greater than expected.  In the future, OIG may explore expanded use of 
biosimilars10 and potential savings therefrom.  
 
Conclusion  
Thank you again for the opportunity to highlight some of our work to the subcommittee 
today.  As noted previously, a significant portion of this work would not be doable without the 
funding provided by this subcommittee.   
Of course, in addition to the work described throughout this testimony, OIG has included 
FDA in its ongoing oversight of Departmental financial and cyber systems.  In covering these 
priority areas, and other concerns at FDA, OIG will continue to pursue recommendation 
implementation as a central part of our work.  We welcome this subcommittees interest in 
                                                           
9 FDA Lacks Comprehensive Data To Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety, OEI-
04-11-00510 (February 2013).  
10 Biosimilars are the biological equivalent of a generic drug.  Biologic drug products are usually large, complex molecules 
produced through a living system, such as a microorganism, plant, or animal cell.  
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FDAs progress toward implementing OIGs outstanding recommendations and are pleased to 
have this opportunity to discuss our FDA work with you.   
In closing, let me say that OIG recognizes that our current FDA workplan as described in 
this testimony does not and cannot cover all the important issues facing FDA.  Based on our risk 
analysis, and given the resources available, OIG has chosen to first and foremost focus on the 
safety of American food, medical devices, and drugs.  This is where we can have the greatest 
positive impact.  If we are able to expand our FDA oversight, potential areas for further FDA 
oversight include (1) assessing the progress that FDA has made on the 21st Century Cures Act 
commitments to help accelerate medical product development and bring new innovations and 
advances to patients who need them faster, and (2) a broader exploration of the intersection 
between FDA drug approvals and a competitive market for drugs and biologics that better 
constrains costs.  
Thank you again for the opportunity to be here today.  I welcome any questions you may 
have.    
 
 
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