What GAO Found
Fiscal year 2015 was the first time that the Food and Drug Administration (FDA) conducted more inspections of foreign drug manufacturers than domestic manufacturers, with the majority conducted in China and India. However, in June 2020, GAO reported that from fiscal year 2016 through fiscal year 2018, both foreign and domestic inspections decreased, in part due to staffing vacancies. While foreign inspections increased in 2019, since March 2020, FDA has largely paused foreign and domestic inspections due to the Coronavirus Disease 2019 (COVID-19) pandemic, conducting only those deemed mission critical. In January 2021, GAO reported that FDA conducted three foreign inspections in fiscal year 2020 following the pause—significantly less than in recent years.
Number of FDA-Conducted Foreign Drug Manufacturing Establishment Inspections, Fiscal Years 2019–2020, by Month
FDA has used alternative inspection tools to maintain some oversight of drug manufacturing quality while inspections are paused. These tools include relying on inspections conducted by foreign regulators, requesting and reviewing records and other information, and sampling and testing drugs. FDA has determined that inspections conducted by certain European regulators are equivalent to and can be substituted for an FDA inspection. Other tools provide useful information but are not equivalent. In addition, FDA was unable to complete more than 1,000 of its planned fiscal year 2020 inspections and will likely face a backlog of inspections in future years. In January 2021, GAO recommended that FDA ensure that inspection plans for future fiscal years respond to the issues presented by the backlog and that FDA fully assess the agency’s alternative inspection tools. FDA concurred with both recommendations.
Even before the COVID-19 pandemic, FDA faced persistent challenges conducting foreign inspections. GAO found in December 2019 that there continued to be vacancies among the investigators who conduct foreign inspections. GAO further found that FDA’s practice of preannouncing foreign inspections up to 12 weeks in advance could give manufacturers the opportunity to fix problems ahead of the inspection and raised questions about their equivalence to domestic inspections. In light of COVID-19, FDA is now preannouncing both foreign and domestic inspections for the safety of its staff and manufacturers. GAO also found that language barriers can create challenges during foreign inspections as FDA generally relies on the establishment for translation services.
Why GAO Did This Study
The outbreak of COVID-19 has called greater attention to the United States’ reliance on foreign drug manufacturers. FDA reports that 74 percent of establishments manufacturing active ingredients and 54 percent of establishments manufacturing finished drugs for the U.S. market were located overseas, as of May 2020. FDA is responsible for overseeing the safety and effectiveness of all drugs marketed in the United States, regardless of where they are produced, and it conducts inspections of both foreign and domestic manufacturing establishments.
GAO has had long-standing concerns about FDA’s ability to oversee the increasingly global pharmaceutical supply chain, an issue highlighted in GAO’s High Risk Series since 2009.
This statement is largely based on GAO’s Drug Manufacturing Inspections enclosure in its January 2021 CARES Act report, as well as GAO’s December 2019 and June 2020 testimonies. Specifically, it discusses (1) the number of FDA’s foreign inspections, (2) FDA’s response to the COVID-19 pandemic pause in inspections, and (3) persistent foreign inspection challenges. For that work, GAO examined FDA data from fiscal years 2012 through 2020, interviewed FDA investigators, and reviewed documents related to drug oversight during the COVID-19 pandemic, among other things.
For more information, contact Mary Denigan-Macauley at (202) 512-7114 or firstname.lastname@example.org.
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However, the increasing connections between airplanes and other systems, combined with the evolving cyber threat landscape, could lead to increasing risks for future flight safety. Figure 1: Key Systems Connections to Commercial Airplanes The Federal Aviation Administration (FAA) has established a process for the certification and oversight of all US commercial airplanes, including the operation of commercial air carriers (see fig. 2). While FAA recognizes avionics cybersecurity as a potential safety issue for modern commercial airplanes, it has not fully implemented key practices that are necessary to carry out a risk-based cybersecurity oversight program. Specifically, FAA has not (1) assessed its oversight program to determine the priority of avionics cybersecurity risks, (2) developed an avionics cybersecurity training program, (3) issued guidance for independent cybersecurity testing, or (4) included periodic testing as part of its monitoring process. Until FAA strengthens its oversight program, based on assessed risks, it may not be able to ensure it is providing sufficient oversight to guard against evolving cybersecurity risks facing avionics systems in commercial airplanes. Figure 2: Federal Aviation Administration's Certification Process for Commercial Transport Airplanes GAO has previously identified key practices for interagency collaboration that can be used to assess interagency coordination. FAA coordinates with other federal agencies, such as the Departments of Defense (DOD) and Homeland Security (DHS), and with industry to address aviation cybersecurity issues. For example, FAA co-chairs the Aviation Cyber Initiative, a tri-agency forum with DOD and DHS to address cyber risks across the aviation ecosystem. However, FAA's internal coordination activities do not fully reflect GAO's key collaboration practices. FAA has not established a tracking mechanism for monitoring progress on cybersecurity issues that are raised in coordination meetings, and its oversight coordination activities are not supported by dedicated resources within the agency's budget. Until FAA establishes a tracking mechanism for cybersecurity issues, it may be unable to ensure that all issues are appropriately addressed and resolved. Further, until it conducts an avionics cybersecurity risk assessment, it will not be able to effectively prioritize and dedicate resources to ensure that avionics cybersecurity risks are addressed in its oversight program. Avionics systems, which provide weather information, positioning data, and communications, are critical to the safe operation of an airplane. FAA is responsible for overseeing the safety of commercial aviation, including avionics systems. The growing connectivity between airplanes and these systems may present increasing opportunities for cyberattacks on commercial airplanes. GAO was asked to review the FAA's oversight of avionics cybersecurity issues. The objectives of this review were to (1) describe key cybersecurity risks to avionics systems and their potential effects, (2) determine the extent to which FAA oversees the implementation of cybersecurity controls that address identified risks in avionics systems, and (3) assess the extent to which FAA coordinates internally and with other government and industry entities to identify and address cybersecurity risks to avionics systems. To do so, GAO reviewed information on key cybersecurity risks to avionics systems, as reported by major industry representatives as well as key elements of an effective oversight program, and compared FAA's process for overseeing the implementation of cybersecurity controls in avionics systems with these program elements. GAO also reviewed agency documentation and interviewed agency and industry representatives to assess FAA's coordination efforts to address the identified risks. GAO is making six recommendations to FAA to strengthen its avionics cybersecurity oversight program: GAO recommends that FAA conduct a cybersecurity risk assessment of avionics systems cybersecurity within its oversight program to identify the relative priority of avionics cybersecurity risks compared to other safety concerns and develop a plan to address those risks. Based on the assessment of avionics cybersecurity risks, GAO recommends that FAA identify staffing and training needs for agency inspectors specific to avionics cybersecurity, and develop and implement appropriate training to address identified needs. develop and implement guidance for avionics cybersecurity testing of new airplane designs that includes independent testing. review and consider revising its policies and procedures for monitoring the effectiveness of avionics cybersecurity controls in the deployed fleet to include developing procedures for safely conducting independent testing. ensure that avionics cybersecurity issues are appropriately tracked and resolved when coordinating among internal stakeholders. review and consider the extent to which oversight resources should be committed to avionics cybersecurity. FAA concurred with five out of six GAO recommendations. FAA did not concur with the recommendation to consider revising its policies and procedures for periodic independent testing. GAO clarified this recommendation to emphasize that FAA safely conduct such testing as part of its ongoing monitoring of airplane safety. For more information, contact Nick Marinos at (202) 512-9342 or MarinosN@gao.gov, or Heather Krause at (202) 512-2834 or KrauseH@gao.gov.[Read More…]
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- Owner of Tax Preparation Business Sentenced to Prison for Filing False ReturnsBy Sam NewsSeptember 25, 2020A former Gulfport, Mississippi, tax return preparer was sentenced to 46 months in prison today for aiding and assisting in the preparation of false returns, announced Principal Deputy Assistant Attorney General Richard E. Zuckerman of the Justice Department’s Tax Division and U.S. Attorney Mike Hurst for the Southern District of Mississippi.[Read More…]
- Wife of “El Chapo” Arrested on International Drug Trafficking ChargesBy Sam NewsFebruary 22, 2021The wife of Joaquin “El Chapo” Guzman Loera, leader of a Mexican drug trafficking organization known as the Sinaloa Cartel, was arrested today in Virginia on charges related to her alleged involvement in international drug trafficking.[Read More…]
- Tax Preparer Charged with COVID-19 Loan FraudBy Sam NewsMarch 17, 2021A South Florida tax preparer was charged Tuesday by criminal information with wire fraud in connection with a scheme to obtain over 100 COVID-19-relief loans under the Paycheck Protection Program (PPP).[Read More…]
- Man Pleads Guilty to Directing COVID-Relief Fraud SchemeBy Sam NewsFebruary 23, 2021A Wisconsin man pleaded guilty today for his role in fraudulently obtaining over $1 million in Paycheck Protection Program (PPP) loans guaranteed by the Small Business Administration (SBA) under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.[Read More…]
- Taiwan Company Pleads Guilty to Trade Secret Theft in Criminal Case Involving PRC State-Owned CompanyBy Sam NewsOctober 28, 2020The Department of Justice today announced that United Microelectronics Corporation, Inc. (UMC), a Taiwan semiconductor foundry, pleaded guilty to criminal trade secret theft and was sentenced to pay a $60 million fine, in exchange for its agreement to cooperate with the government in the investigation and prosecution of its co-defendant, a Chinese state-owned-enterprise.[Read More…]
- New York City Restaurateur Sentenced to Jail For Tax Evasion SchemeBy Sam NewsDecember 1, 2020A New York City restaurateur was sentenced to prison for a tax evasion scheme.[Read More…]