January 29, 2022

News

News Network

Over-The-Counter Drugs: Information on FDA’s Regulation of Most OTC Drugs

19 min read
<div>The Food and Drug Administration (FDA) has regulated most over-the-counter (OTC) drugs—that is, drugs available without a prescription—through the OTC monograph process. FDA has described an OTC monograph as a "rulebook" for marketing safe and effective OTC drugs, such as aspirin, cough and cold medicine, and hand sanitizer. OTC monographs established conditions—such as active ingredients, indications for use, dosage forms, and product labeling—under which an OTC drug was generally recognized as safe and effective. According to FDA officials, before the CARES Act, which was enacted in March 2020, the agency's ability to update and finalize monographs in response to safety issues and to reflect new scientific information was limited by the rulemaking process the agency was required to follow, as well as insufficient resources. Agency officials estimated that it took at least 6 years to complete the required rulemaking process. Additionally, the agency reported it was critically under-resourced to regulate the estimated 100,000 OTC drugs marketed through the monograph process. However, the CARES Act provided for a new process to regulate these OTC drugs rather than the rulemaking process. FDA officials expect it will take less time to update and finalize requirements for OTC drugs using the new process. The CARES Act also authorized FDA to assess user fees to provide additional resources to regulate OTC drugs. Although FDA officials said this new process and user fees should improve its regulation of OTC drugs, the agency's analysis of the effect of the CARES Act is still ongoing. FDA officials told GAO that prior to the CARES Act, they used various methods to identify and respond to safety issues related to OTC drugs. For example, to identify these issues, FDA officials said they read medical literature related to safety issues and reviewed reports submitted to the agency's adverse event reporting system. To respond to these issues, FDA took steps such as issuing drug safety communications to consumers and requesting that manufacturers make changes to a drug's labeling. For example, in 2015, two FDA advisory committees recommended that cough and cold drugs with codeine be removed from the relevant OTC monograph for use in drugs in children. In 2018, FDA also issued a drug safety communication stating the risks outweighed the benefits for the use of these drugs in children. However, FDA officials said these methods were not a substitute for rulemaking because manufacturers could legally market their OTC drugs without making requested safety changes until the rulemaking process was completed. According to FDA officials, the new process for regulating OTC drugs included in the CARES Act could improve FDA's ability to address identified safety risks in a more timely and efficient manner in the future. The act established an expedited process to address safety issues that pose an imminent hazard to public health or to change a drug's labeling to mitigate a significant or unreasonable risk of a serious adverse event. OTC drugs prevent and treat a variety of conditions; for example, sunscreen is used to help prevent sunburn. FDA officials and stakeholders, such as industry representatives and patient and provider groups, have questioned whether the monograph process used to regulate most OTC drugs has been overly burdensome and has limited FDA's ability to quickly update and finalize monographs in response to potential safety issues for consumers. Enacted in March 2020, the CARES Act changed how FDA regulates OTC drugs. The Sunscreen Innovation Act included a provision for GAO to review FDA's regulation of OTC drugs. This report describes, among other issues, (1) the factors that affected FDA's ability to regulate OTC drugs and (2) how FDA identified and responded to safety issues associated with these drugs. GAO reviewed federal statutes and agency documents and interviewed FDA officials and stakeholders familiar with the monograph process. These stakeholders included representatives from the OTC drug industry, health care provider and consumer groups, and researchers. The Department of Health and Human Services provided technical comments on this report, which GAO incorporated as appropriate. For more information, contact John E. Dicken at (202) 512-7114 or dickenj@gao.gov.</div>

What GAO Found

The Food and Drug Administration (FDA) has regulated most over-the-counter (OTC) drugs—that is, drugs available without a prescription—through the OTC monograph process. FDA has described an OTC monograph as a “rulebook” for marketing safe and effective OTC drugs, such as aspirin, cough and cold medicine, and hand sanitizer. OTC monographs established conditions—such as active ingredients, indications for use, dosage forms, and product labeling—under which an OTC drug was generally recognized as safe and effective.

According to FDA officials, before the CARES Act, which was enacted in March 2020, the agency’s ability to update and finalize monographs in response to safety issues and to reflect new scientific information was limited by the rulemaking process the agency was required to follow, as well as insufficient resources. Agency officials estimated that it took at least 6 years to complete the required rulemaking process. Additionally, the agency reported it was critically under-resourced to regulate the estimated 100,000 OTC drugs marketed through the monograph process. However, the CARES Act provided for a new process to regulate these OTC drugs rather than the rulemaking process. FDA officials expect it will take less time to update and finalize requirements for OTC drugs using the new process. The CARES Act also authorized FDA to assess user fees to provide additional resources to regulate OTC drugs. Although FDA officials said this new process and user fees should improve its regulation of OTC drugs, the agency’s analysis of the effect of the CARES Act is still ongoing.

FDA officials told GAO that prior to the CARES Act, they used various methods to identify and respond to safety issues related to OTC drugs. For example, to identify these issues, FDA officials said they read medical literature related to safety issues and reviewed reports submitted to the agency’s adverse event reporting system. To respond to these issues, FDA took steps such as issuing drug safety communications to consumers and requesting that manufacturers make changes to a drug’s labeling. For example, in 2015, two FDA advisory committees recommended that cough and cold drugs with codeine be removed from the relevant OTC monograph for use in drugs in children. In 2018, FDA also issued a drug safety communication stating the risks outweighed the benefits for the use of these drugs in children. However, FDA officials said these methods were not a substitute for rulemaking because manufacturers could legally market their OTC drugs without making requested safety changes until the rulemaking process was completed.

According to FDA officials, the new process for regulating OTC drugs included in the CARES Act could improve FDA’s ability to address identified safety risks in a more timely and efficient manner in the future. The act established an expedited process to address safety issues that pose an imminent hazard to public health or to change a drug’s labeling to mitigate a significant or unreasonable risk of a serious adverse event.

Why GAO Did This Study

OTC drugs prevent and treat a variety of conditions; for example, sunscreen is used to help prevent sunburn. FDA officials and stakeholders, such as industry representatives and patient and provider groups, have questioned whether the monograph process used to regulate most OTC drugs has been overly burdensome and has limited FDA’s ability to quickly update and finalize monographs in response to potential safety issues for consumers. Enacted in March 2020, the CARES Act changed how FDA regulates OTC drugs.

The Sunscreen Innovation Act included a provision for GAO to review FDA’s regulation of OTC drugs. This report describes, among other issues, (1) the factors that affected FDA’s ability to regulate OTC drugs and (2) how FDA identified and responded to safety issues associated with these drugs.

GAO reviewed federal statutes and agency documents and interviewed FDA officials and stakeholders familiar with the monograph process. These stakeholders included representatives from the OTC drug industry, health care provider and consumer groups, and researchers.

The Department of Health and Human Services provided technical comments on this report, which GAO incorporated as appropriate.

For more information, contact John E. Dicken at (202) 512-7114 or dickenj@gao.gov.

News Network

  • Associate Attorney General Vanita Gupta Delivers Remarks at Georgetown Law’s 15th Annual Global Antitrust Enforcement Symposium
    In Crime News
    Thank you for that kind introduction and for inviting me to speak at the 15th Annual Global Antitrust Enforcement Symposium hosted by Georgetown Law School. I bring greetings from the Attorney General.
    [Read More…]
  • Secretary Antony J. Blinken On ABC’s This Week with George Stephanopoulos
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • U.S. Holocaust Memorial Museum Honors DOJ with Elie Wiesel Award
    In Crime News
    The U.S. Holocaust Memorial Museum last night conferred their highest honor, the Elie Wiesel Award, on the U.S. Department of Justice in recognition of the successes of its longtime enforcement program’s efforts to identify, investigate, and prosecute participants in World War II-era Nazi crimes.
    [Read More…]
  • Secretary Antony J. Blinken at UN Security Council Meeting on Climate and Security
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • Angola Travel Advisory
    In Travel
    Reconsider travel to [Read More…]
  • Secretary Antony J. Blinken Remarks at the Virtual 2022 U.S.-Japan Security Consultative Committee Meeting with Defense Secretary Lloyd Austin, Japanese Foreign Minister Hayashi Yoshimasa, and Japanese Defense Minister Kishi Nobuo
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • Secretary Blinken’s Meeting with Republic of Korea Foreign Minister Chung
    In Crime Control and Security News
    Office of the [Read More…]
  • COVID-19: Additional Actions Needed to Improve Accountability and Program Effectiveness of Federal Response
    In U.S GAO News
    What GAO Found As the nation continues to respond to, and recover from, the COVID-19 pandemic, increases in COVID-19 cases in July, August, and September 2021, primarily due to the Delta variant of the virus, have hampered these efforts. From the end of July 2021 to September 23, 2021, the number of new cases reported each day generally exceeded 100,000, according to Centers for Disease Control and Prevention (CDC) data. This was a daily case count not seen since February 2021 (see figure). Reported COVID-19 Cases per Day in the U.S., Mar. 1, 2020–Sept. 23, 2021 Meanwhile, COVID-19 vaccination efforts continue. As of September 23, 2021, about 64 percent of the U.S. population eligible for vaccination (those 12 years and older), or almost 183 million individuals, had been fully vaccinated, according to CDC. The government must remain vigilant and agile to address the evolving COVID-19 pandemic and its cascading impacts. Furthermore, as the administration implements the provisions in the COVID-19 relief laws, the size and scope of these efforts—from distributing funding to implementing new programs—demand strong accountability and oversight. In that vein, GAO has made 209 recommendations across its body of COVID-19 reports issued since June 2020. As of September 30, 2021, agencies had addressed 33 of these recommendations, resulting in improvements including increased oversight of relief payments to individuals and improved transparency of decision-making for emergency use authorizations for vaccines and therapeutics. Agencies partially addressed another 48 recommendations. GAO also raised four matters for congressional consideration, three of which remain open. In this report, GAO is making 16 new recommendations, including recommendations related to fiscal relief funds for health care providers, recovery funds for states and localities, worker safety and health, and assessing fraud risks to unemployment insurance programs. GAO’s recommendations, if swiftly and effectively implemented, can help improve the government’s ongoing response and recovery efforts as well as help it to prepare for future public health emergencies. GAO’s new findings and recommendations, where applicable, are discussed below. Relief for Health Care Providers A total of $178 billion has been appropriated to the Provider Relief Fund (PRF) to reimburse eligible providers for health care–related expenses or lost revenues attributable to COVID-19. As of August 31, 2021, the Department of Health and Human Services (HHS) had allocated and disbursed about $132.5 billion of this amount and had allocated but not yet disbursed about $21.5 billion; the remaining $24.1 billion was unallocated and undisbursed. On September 10, 2021, HHS announced that $17 billion of the previously unallocated $24.1 billion would be allocated for a general distribution to a broad range of providers who could document COVID-related revenue loss and expenses. HHS expected to begin disbursing the funds in December 2021. As of September 2021, HHS’s Health Resources and Services Administration (HRSA) had not established time frames for implementing and completing post payment reviews for all PRF payments. In addition, the agency had not finalized procedures for recovery of overpayments or recovered the bulk of the overpayments that it had already identified. Without post-payment oversight to help ensure that relief payments are made only to eligible providers in correct amounts and to identify unused payments or payments not properly used, HHS cannot fully address stated payment integrity risks for the PRF and seek to recover overpayments, unused payments, or payments not properly used. GAO recommends that HRSA take steps to finalize and implement post-payment oversight. Specifically, HRSA should establish time frames for completing post-payment reviews to promptly address identified risks and identify overpayments made from the PRF, such as payments made in incorrect amounts or payments to ineligible providers; and it should finalize procedures and implement post-payment recovery of any PRF overpayments, unused payments, or payments not properly used. HHS—which includes HRSA—partially agreed with these recommendations. Coronavirus State and Local Fiscal Recovery Funds In March 2021, the American Rescue Plan Act of 2021 (ARPA) appropriated $350 billion to the Department of the Treasury (Treasury) to provide payments from the Coronavirus State and Local Fiscal Recovery Funds (CSLFRF). The CSLFRF allocates funds to states, the District of Columbia, localities, tribal governments, and U.S. territories to cover a broad range of costs stemming from the COVID-19 pandemic’s fiscal effects. According to Treasury data, it had distributed approximately $240 billion from the CSLFRF to recipients as of August 31, 2021 (see figure). Coronavirus State and Local Fiscal Recovery Funds Allocations and Treasury Distributions as of Aug. 31, 2021, by Recipient Type Note: For more details, see the Coronavirus State and Local Fiscal Recovery Funds enclosure in appendix I.aNon-entitlement units of local government are local governments typically serving populations of less than 50,000.As of July 2021, some of the 48 states that responded to GAO’s survey reported that they had somewhat less than or much less than sufficient capacity to report on their use of CSLFRF allocation consistent with federal requirements (17 of 48 states), capacity to disburse the funds (13 of 48 states), and apply appropriate internal controls and respond to inquiries about requirements (10 of 48 states). In addition, most states (44 of 48) reported that they had taken or planned to take additional steps—such as hiring new staff or reassigning existing staff—to help them manage their CSLFRF allocations. As of August 2021, Treasury was developing—but had not finalized or documented—key internal processes and control activities to monitor recipients’ use of their CSLFRF allocations for allowable purposes and to respond to internal control and compliance findings. According to officials, these internal processes and control activities were in the development stage, partly because of the short time frame since ARPA’s enactment and because Treasury’s Office of Recovery Programs, established in April 2021, continues to work to recruit and onboard key team members. Until Treasury properly designs and documents policies and procedures to guide CSLFRF program officials and other responsible oversight parties in the Office of Recovery Programs, there is a risk that key control activities needed to help ensure program management fulfills its recipient monitoring and oversight responsibilities may not be established or applied effectively and consistently. This risk may be particularly acute with respect to monitoring state and local recipients that face capacity challenges in managing their CSLFRF allocations in accordance with federal requirements, as some survey respondents noted. GAO recommends that Treasury design and document timely and sufficient policies and procedures for monitoring CSLFRF recipients to provide assurance that recipients are managing their allocations in compliance with laws, regulations, agency guidance, and award terms and conditions. Treasury agreed with the recommendation. Unemployment Insurance Fraud Risk Management GAO continues to have concerns about potential fraud in the unemployment insurance (UI) program, including concerns about Department of Labor (DOL) efforts to assess and manage program fraud risks. During the pandemic, fraudulent and potentially fraudulent activity has increased substantially and new types of fraud have emerged, according to DOL officials. For example, in June 2021, DOL’s Office of Inspector General reported that it had identified nearly $8 billion in potentially fraudulent UI benefits paid from March 2020 through October 2020. Improper payments have also been a long-standing concern in the regular unemployment insurance program, suggesting that the program may be vulnerable to fraud. While DOL continues to identify and implement strategies to address potential fraud and has some ongoing program integrity activities, it has not comprehensively assessed fraud risks in alignment with leading practices identified in GAO’s Fraud Risk Framework, which by law must be incorporated in guidelines established by the Office of Management and Budget for agencies. DOL has not clearly assigned defined responsibilities to a dedicated entity for designing and overseeing fraud risk management activities. Without a dedicated entity with defined responsibilities to lead antifraud initiatives, including the process of assessing fraud risks to UI programs, DOL may not be strategically managing UI fraud risks. GAO recommends that DOL designate a dedicated entity and document its responsibilities for managing the process of assessing fraud risks to the unemployment insurance program, consistent with leading practices as provided in GAO’s Fraud Risk Framework. This entity should have, among other things, clearly defined and documented responsibilities and authority for managing fraud risk assessments and for facilitating communication among stakeholders regarding fraud-related issues. DOL neither agreed nor disagreed with this recommendation. DOL also has not comprehensively assessed UI fraud risks in alignment with leading practices identified in GAO’s Fraud Risk Framework. These leading practices call for federal managers to plan regular fraud risk assessments and determine their fraud risk profile, among other things. Such assessments would provide reasonable assurance that DOL has identified the most significant fraud risks for the regular UI program that will exist after the pandemic. For example, some fraud risks identified in the CARES Act UI programs may continue to exist in the regular UI program after the temporary UI programs expire. GAO recommends that DOL (1) identify inherent fraud risks facing the unemployment insurance program, (2) assess the likelihood and impact of inherent fraud risks facing the program, (3) determine fraud risk tolerance for the program, (4) examine the suitability of existing fraud controls in the program and prioritize residual fraud risks, and (5) document the fraud risk profile for the program. DOL neither agreed nor disagreed with these recommendations. FEMA’s Disaster Relief Fund and Assistance to State, Local, Tribal, and Territorial Governments The Federal Emergency Management Agency (FEMA) has used the Disaster Relief Fund to respond to the COVID-19 pandemic—the first time the fund has been used during a nationwide public health emergency. For example, from September 1, 2020 to August 31, 2021, FEMA obligated a total of approximately $26.8 billion through one type of disaster assistance, Public Assistance, for emergency protective measures, such as eligible medical care, the purchase and distribution of food, and distribution of personal protective equipment. GAO found that FEMA inconsistently interpreted and applied its policies for expenses eligible for COVID-19 Public Assistance within and across its 10 regions. For example, officials in one state said that FEMA at one point had deemed the provision of personal protective equipment at correctional facilities as ineligible for reimbursement in their region but that states in other regions had received reimbursement for the same expense. These inconsistencies were due to, among other things, changes in policies as FEMA used the Public Assistance program for the first time to respond to a nationwide emergency. FEMA officials stated that it was difficult to ensure consistency in policies as different states and regions are not experiencing the same things at the same time. FEMA is likely to receive applications for reimbursement for a larger number of projects than it estimated earlier in 2021, given the surge in COVID-19 cases this summer. To improve the consistency of the agency’s interpretation and application of the COVID-19 Public Assistance policy, GAO recommends that FEMA further clarify and communicate eligibility requirements nationwide. GAO also recommends that FEMA require the agency’s Public Assistance employees in the regions and at its Consolidated Resource Centers to attend training on changes to COVID-19 Public Assistance policy. The Department of Homeland Security—which includes FEMA— agreed with both of these recommendations. Loans for Aviation and Other Eligible Businesses Treasury has executed 35 loan agreements with certain aviation businesses and other businesses deemed critical to maintaining national security. These loans have totaled about $22 billion of the $46 billion authorized by the CARES Act for loans and loan guarantees to such businesses. As directed by the CARES Act, Treasury required certain loan recipients to provide financial assets, such as warrants that give the federal government an option to buy shares of stock at a predetermined price before a specified date, to protect taxpayer interests. According to Treasury officials, it is likely that, if the airline industry continues to recover and borrowers do not default, the warrants could have higher values than the predetermined price Treasury would have to pay to act on them. Treasury has not exercised any of the warrants for stock it received from nine businesses, nor has it developed policies and procedures for determining when to act on the warrants to benefit the taxpayer. GAO recommends that Treasury develop policies and procedures to determine when to act on warrants obtained as part of the loan program for aviation and other eligible businesses to benefit the taxpayers. Treasury agreed with this recommendation. Payroll Support Assistance to Aviation Businesses As of September 2021, Treasury had made payments totaling $59 billion of $63 billion provided for the Payroll Support Programs to support aviation business. These payments were to be used exclusively for the continuation of wages, salaries, and benefits. Similar to Treasury’s requirement for loans for aviation and other eligible businesses, Treasury required certain Payroll Support Program recipients to provide warrants, as allowed by the CARES Act. As of September 2021, 14 recipients had provided a total of 58 million warrants. As Treasury continues to hold these warrants for stock purchases, the warrants may increase in value as the airline industry recovers. Treasury has not exercised any of the warrants for stock it holds in the 14 businesses, nor has it documented policies and procedures to guide when to act on the warrants to fulfill the statutory purpose to provide appropriate compensation to the federal government. GAO recommends that Treasury develop policies and procedures to determine when to act on warrants obtained as part of the Payroll Support Program to provide appropriate compensation to the federal government. Treasury agreed with this recommendation. COVID-19 Testing Use is increasing for antigen tests, one of two types of COVID-19 diagnostic and screening tests for which HHS’s Food and Drug Administration has issued emergency use authorizations. These “rapid” antigen tests typically have a turnaround time of about 30 minutes or less for results, compared with 1 to 3 days for molecular tests, the second type of test HHS authorized. Antigen tests can be conducted at doctors’ offices or in homes or other settings; some antigen tests can be conducted without a prescription. Since June 2020, HHS has worked to encourage and improve the reporting of antigen testing data to local, state, and federal health officials. However, HHS officials told GAO reporting of antigen test results is incomplete, which prevents HHS from using antigen testing data for COVID-19 surveillance. HHS is taking additional steps aimed at improving reporting of antigen test data. For example, officials told GAO that HHS will continue to make enhancements to data reporting by building reporting methods into the testing process, such as for testing in schools and workplaces. HHS is also considering surveillance approaches to supplement or enhance current surveillance efforts. For example, HHS is exploring wastewater surveillance approaches, which provide data that can complement and confirm other forms of surveillance for COVID-19 and an efficient pooled community sample that is particularly useful in areas where timely COVID-19 clinical testing is underutilized or unavailable, according to HHS officials. Worker Safety and Health The Occupational Safety and Health Administration (OSHA) faced challenges in enforcing workplace safety and health standards during the COVID-19 pandemic, but the agency has not assessed lessons learned or promising practices. According to inspectors from area offices, they faced challenges related to resources and to communication and guidance, such as a lack of timely guidance from OSHA headquarters. GAO recommends that OSHA assess—as soon as feasible and, as appropriate, periodically thereafter—various challenges related to resources and to communication and guidance that the agency has faced in its response to the COVID-19 pandemic and take related actions as warranted. The Department of Labor—which includes OSHA—partially agreed with this recommendation. Advance Child Tax Credit Payments ARPA temporarily expanded eligibility for the child tax credit (CTC) to additional qualified individuals by eliminating a requirement that individuals must earn a minimum amount annually to be eligible. ARPA also temporarily increased the maximum amount of the CTC from $2,000 per qualifying child to $3,000 or $3,600, depending on the child’s age. As required by ARPA, the Internal Revenue Service (IRS) and Treasury are responsible for issuing half of the CTC through periodic advance payments, known as advance CTC payments. IRS reported disbursing more than 106 million advance payments totaling over $45.5 billion as of September 25, 2021 (see figure). Dollar Amount and Count of Advance Child Tax Credit Payments, by Month, as of Sept. 25, 2021 IRS is conducting and planning several outreach efforts to increase the public’s awareness of advance CTC payments. However, IRS and Treasury have not developed a comprehensive estimate of individuals who are potentially eligible for advance CTC payments and the agencies have not set a participation goal. Such an estimate would enable Treasury and IRS to measure the tax credit’s participation rate, providing greater clarity regarding populations at risk of not receiving the payments. GAO recommends that Treasury, in coordination with IRS, estimate the number of individuals, includingnonfilers, who are eligible for advance CTC payments, measure the 2021 participation rate based on that estimate, and use that estimate to develop targeted outreach and communications efforts for the 2022 filing season; the participation rate could include individuals who opt in and out of the advance payments. Treasury neither agreed nor disagreed with this recommendation. Child Nutrition Child nutrition programs administered by the Department of Agriculture’s Food and Nutrition Service (FNS) supply cash reimbursements to schools or other programs for meals and snacks provided to eligible children nationwide. In fiscal year 2019, before the pandemic, the four largest programs—the National School Lunch Program, School Breakfast Program, Summer Food Service Program, and Child and Adult Care Food Program—along with other child nutrition programs, received $23.1 billion in federal funds. During a typical year, two of these programs—the National School Lunch Program and the School Breakfast Program—subsidize meals for nearly 30 million children in approximately 95,000 elementary and secondary schools nationwide. As of July 2021, FNS officials were unable to provide a plan showing how FNS intends to comprehensively analyze lessons learned during the pandemic, such as from operational and financial challenges. Further, according to FNS officials, while the School Meals Operations study—launched in spring 2021—is surveying school districts and state agencies that administer the federal child nutrition programs, the study is not gathering local perspectives directly from child care centers and day care homes or other local program sponsors that are not school districts. As a result, FNS may miss opportunities to identify lessons learned and will lack comprehensive information to aid its future planning. GAO recommends that the Department of Agriculture document its plan to analyze lessons learned from operating child nutrition programs during the COVID-19 pandemic. This plan should include a description of how the department will gather perspectives of key stakeholders, such as Child and Adult Care Food Program institutions and nonschool Summer Food Service Program sponsors. The Department of Agriculture—which includes FNS—agreed with this recommendation. Why GAO Did This Study As of September 23, 2021, the U.S. had about 43 million reported cases of COVID-19 and about 699,000 reported deaths, according to CDC. The country also continues to experience economic repercussions from the pandemic. Six relief laws, including the CARES Act, had been enacted as of August 31, 2021, to address the public health and economic threats posed by COVID-19. As of that same date (the most recent for which government-wide data was available), the federal government had obligated a total of $3.9 trillion and expended $3.4 trillion of the $4.8 trillion in COVID-19 relief funds that had been appropriated by these six laws, as reported by federal agencies. The CARES Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report examines the federal government’s continued efforts to respond to, and recover from, the COVID-19 pandemic. GAO reviewed data, documents, and guidance from federal agencies about their activities. GAO also interviewed federal and state officials, stakeholders from organizations for localities, and other stakeholders.
    [Read More…]
  • Justice Department Updates 2015 Business Review Letter To The Institute Of Electrical And Electronics Engineers
    In Crime News
    The Justice Department today issued a supplement to its Feb. 2, 2015 Business Review Letter from the Antitrust Division to the Institute of Electrical and Electronics Engineers, Incorporated (IEEE) (“the 2015 Letter”).  The 2015 Letter analyzed proposed revisions to the IEEE’s Patent Policy of that same year pursuant to the department’s Business Review Procedure, 28 C.F.R. § 50.6.  The Antitrust Division took this step to address concerns raised publicly by industry, lawmakers, and former department and other federal government officials that the 2015 letter has been misinterpreted, and cited frequently and incorrectly, as an endorsement of the IEEE’s Patent Policy.  Additionally, aspects of the 2015 letter had become outdated based on recent jurisprudential and policy developments.
    [Read More…]
  • Italy Travel Advisory
    In Travel
    Reconsider travel to [Read More…]
  • Six Language Recruiters Indicted for Recruiting Unqualified Linguists for Deployment with U.S. Armed Forces in Afghanistan
    In Crime News
    A federal grand jury in the Eastern District of Virginia returned an indictment Wednesday charging six former employees of a government contractor for their role in a conspiracy to commit wire fraud in connection with a U.S. government contract to recruit and deploy qualified linguists to Afghanistan where they would provide language services in Dari and Pashto to the U.S. military, including interacting with Afghan civilians and military forces.
    [Read More…]
  • Lebanon National Day
    In Crime Control and Security News
    Michael R. Pompeo, [Read More…]
  • Attorney General William P. Barr Announces Publication of Cryptocurrency Enforcement Framework
    In Crime News
    Attorney General William P. Barr announced today the release of “Cryptocurrency: An Enforcement Framework,” a publication produced by the Attorney General’s Cyber-Digital Task Force.  The Framework provides a comprehensive overview of the emerging threats and enforcement challenges associated with the increasing prevalence and use of cryptocurrency; details the important relationships that the Department of Justice has built with regulatory and enforcement partners both within the United States government and around the world; and outlines the Department’s response strategies. 
    [Read More…]
  • Mail-Order Diabetic Testing Supplier and Parent Company Agree to Pay $160 Million to Resolve Alleged False Claims to Medicare
    In Crime News
    Arriva Medical LLC (Arriva), at one point the nation’s largest Medicare mail-order diabetic testing supplier, and its parent, Alere Inc. (Alere), have agreed to pay $160 million to resolve allegations that they violated the False Claims Act.
    [Read More…]
  • Warfighter Support: DOD Needs a Complete Picture of the Military Services’ Prepositioning Programs
    In U.S GAO News
    The services preposition combat and support assets ashore and afloat worldwide, including in the Indo-Pacific region. Prepositioned assets include combat vehicles, equipment sets for engineering and construction, and protective gear for chemical or biological attacks. During the COVID-19 pandemic, the Department of Defense (DOD) used prepositioned medical assets for personnel in Guam, South Korea, and Germany. All of the services have reported some shortfalls in their prepositioned assets from 2015 through 2019—including mortars, combat vehicles, and medical equipment. In the Indo-Pacific region, for example, the Army reported shortfalls in equipment to construct bridges over difficult terrain. All services also cited challenges, such as insufficient storage space, storage facilities located far away from intended points of use, and the perishability of some assets. In some cases, the services are taking actions to address these shortfalls and challenges. In others, the services are accepting risk because, according to officials, not all shortfalls and challenges can be fully addressed. Sailors and Marines Offload Assets from a Prepositioning Ship during the COVID-19 Response in Guam DOD has taken steps to implement a joint oversight framework but does not have a complete view of the services' prepositioning programs. DOD revised two guidance documents—an instruction in 2019 and a strategic implementation plan in 2020—to establish a joint oversight framework. However, DOD has focused much of its joint efforts to date on preparing a required annual report to Congress on the status of the services' prepositioning programs. While the report provides some useful information, GAO found inaccurate and inconsistent information in multiple annual reports, which hinder their utility. DOD does not have a reporting mechanism or information-collection tool to develop a complete picture of the services' prepositioning programs. The current annual reporting requirement expires in 2021, which provides DOD with an opportunity to create a new reporting mechanism, or modify existing mechanisms or tools, to enable a complete picture of the services' prepositioning programs. By doing so, DOD could better identify gaps or redundancies in the services' programs, make more informed decisions to mitigate asset shortfalls and challenges, reduce potential duplication and fragmentation, and improve its joint oversight. The U.S. military services preposition critical assets at strategic locations around the world for access during the initial phases of an operation. DOD uses these prepositioned assets for combat, support to allies, and disaster and humanitarian assistance. For many years, GAO has identified weaknesses in DOD's efforts to establish a joint oversight framework to guide its ability to assess the services' prepositioning programs. This has led to fragmentation and the potential for duplication. Senate Report 116-48 included a provision for GAO to evaluate the services' prepositioning programs and associated challenges. This report (1) describes the types of assets the services preposition worldwide, as well as asset shortfalls and challenges the services have identified, and (2) assesses the extent to which DOD has made progress in implementing a joint oversight framework for the services' programs. To conduct this work, GAO reviewed DOD prepositioning documents and interviewed DOD and State Department officials from over 20 offices. This is a public version of a sensitive report that GAO issued in December 2020. Information that DOD deemed sensitive has been omitted. GAO recommends that DOD develop a reporting mechanism or tool to gather complete information about the military services' prepositioning programs for joint oversight and to reduce duplication and fragmentation. DOD concurred with the recommendation. For more information, contact Cary B. Russell at (202) 512-5431 or russellc@gao.gov.
    [Read More…]
  • Priority Open Recommendations: Department of Homeland Security
    In U.S GAO News
    What GAO Found In April 2020, GAO identified 29 priority recommendations for the Department of Homeland Security (DHS). Since then, DHS has implemented 12 of those recommendations. In doing so, DHS implemented a more accurate methodology for the National Flood Insurance Program, strengthened efforts to address fraud risks within the asylum process, improved the U.S. Customs and Border Protection's (CBP) risk management in the collection of antidumping and countervailing (AD/CV) duties, and strengthened the effectiveness of the Transportation Security Administration's Transportation Worker Identification Credential, covert testing, and pipeline security programs. In addition, DHS established metrics for assessing the National Cybersecurity and Communications Integration Center's execution of statutory required cybersecurity functions, identified the positions in its information technology workforce that performed cybersecurity functions, and developed a cybersecurity risk management strategy. DHS has also improved CBP's radiological license verification policies and procedures. In August 2021, GAO identified 21 additional priority recommendations for DHS, bringing the total number to 38. The 38 recommendations fall into the following areas: Emergency preparedness and response. Border security. Transportation security. Infrastructure and management. Information technology and cybersecurity. Chemical and nuclear security. DHS's continued attention to these issues could lead to significant improvements in government operations. Why GAO Did This Study Priority open recommendations are the GAO recommendations that warrant priority attention from heads of key departments or agencies because their implementation could save large amounts of money; improve congressional and/or executive branch decision-making on major issues; eliminate mismanagement, fraud, and abuse; or ensure that programs comply with laws and funds are legally spent, among other benefits. Since 2015, GAO has sent letters to selected agencies to highlight the importance of implementing such recommendations. For more information, contact Charles M. Johnson, Jr. at (202) 512-8777 or johnsoncm@gao.gov.
    [Read More…]
  • Science & Tech Spotlight: Consumer Electronics Recycling
    In U.S GAO News
    Why This Matters Consumer electronics contain critical materials whose supplies are limited, including gold, platinum, and rare earth metals. Domestic recycling of consumer electronics could extend the supply and reduce the current U.S. reliance on imports. New technologies are becoming available, but electronics recycling is complex and faces challenges, such as narrow profit margins. The Technology What is it? Recycling of consumer electronics—including smartphones, televisions, and computers—generally involves separating high-value metals from plastics and other low-value materials. Precious metals and rare earth metals are the economic driving force for consumer electronic recycling technology. These metals have high market values and limited supplies, and they can be reused across many industries, including the defense and energy sectors. Consumer electronic devices can also contain personally identifiable information (PII), including medical and financial data, which could be improperly disclosed if they are not destroyed prior to recycling. According to a study of selected consumer electronics, about 2.8 million tons were disposed of in the U.S. in 2017, of which about 36 percent was recycled. Figure 1. Selected valuable, hazardous, and digital materials contained within consumer electronics that can be recovered, disposed, or destroyed There is no federal standard requiring consumer electronics recycling. Some states have enacted electronics recycling laws requiring electronics producers to pay fees or contract with businesses to ensure electronic waste is collected for recycling. The U.S. recycles electronics domestically and also exports electronics for recycling abroad. How does it work? The high concentration of valuable material in certain consumer electronics is key to the economic viability of recycling these products. Cell phones, as one example, have more precious metal by weight than raw ore does. According to the EPA, 35,274 pounds of copper, 772 pounds of silver, and 75 pounds of gold can be recovered from a million recycled cell phones. Based on commodity market prices on August 12, 2020, these weights of metals are worth approximately $100,000, $290,000, and $2.1 million for copper, silver, and gold, respectively. In contrast, cathode ray tube (CRT) displays in older televisions and computer monitors have little recycling value, but they contain leaded glass and may be considered hazardous waste. In addition, recovery of certain valuable materials from consumer electronics is limited due to the high costs of technology and processing. Electronics recycling companies disassemble devices by shredding, which also destroys PII, or by hand. These companies then separate valuable materials for reuse (including gold, silver, platinum, and rare earth metals) from toxic materials for disposal (including brominated materials and lead). Traditional methods include burning to remove non-metal parts and separation using strong acids. New separation technologies are being used or piloted to recover precious and rare earth metals. For example, robotic disassembly uses machine learning and computer vision to more rapidly pick and sort items. Another new technology uses ultrasound to speed up the chemical removal of gold from cell phone SIM cards. Figure 2. Emerging separation technologies for recycled electronics Other technologies are emerging, like biometallurgy, which uses microorganisms to separate high-value metals from other materials, such as plastics, glass, and glue. For example, naturally occurring bacteria can oxidize gold in acidic solutions, making it soluble and thus easier to separate from other materials. Other advanced techniques, such as magnetic or electrochemical separation, are showing promise in the laboratory with existing technology. For example, in one study, researchers used ultrasound to dissolve nickel and gold within a SIM card. They then used a magnetic field to separate the dissolved nickel, which is magnetic, from the gold, which is not. Similarly, other techniques use electric fields to separate dissolved metals based on their weight and electric charge. How mature is it? Recycling technology is well established for some traditional single-stream processes, such as aluminum recycling. However, electronic devices are more complex and require disassembly and separation. At least one consumer electronics manufacturer is piloting robotic disassembly for its products. Emerging separation technologies such as ultrasound have come to market in the past decade and are being used. Manual disassembly and shredding are decades old. Biometallurgy is being tested in pilot plants, and new microorganisms are being developed in laboratories to treat electronic waste. Opportunities Increase supply and reduce imports. Recycling could increase the domestic supply of precious and rare earth metals and reduce the current U.S. reliance on overseas sources. Grow the green economy. Developing advanced recycling technologies could promote domestic business and employment. Reduce hazardous practices. A significant amount of recycling currently occurs in the developing world, where methods include open-pit burning. New technology could reduce the use of such methods, which are hazardous to the environment and human health. Lessen environmental impacts. Developing advanced recycling technologies could reduce the environmental impacts of raw ore mining and landfill disposal of hazardous materials such as lead and brominated materials. Challenges Market challenges. Markets for recovered materials may be limited, and the value of recovered materials may not be enough to cover the costs of equipment for collection, sorting, disassembly, and separation. Secure destruction of personal information. Many electronic devices contain PII. Shredding them may effectively destroy PII but may also make high-value material harder to recover. Counterfeit electronic parts. Exported used electronics may serve as a source of counterfeit electronic parts, which, as GAO previously reported, could disrupt parts of the Department of Defense supply chain and threaten the reliability of weapons systems. (See GAO-16-236, linked below.) Rapid technological development. As consumer electronics made with new materials get smaller, new technologies for separation may be needed to recycle valuable materials. Policy Context and Questions With the volume of electronic waste expected to grow, questions include: How can programs to support technological innovation, economic development, and advanced manufacturing be leveraged to promote a more robust domestic electronics recycling industry? What efforts can the federal government, states, and others make to incentivize recycling rather than disposal? What are the potential benefits and challenges of such policies? What strategies can the public and private sectors implement to address the risk that exports of used electronics will contribute to unsafe recycling practices, disclosure of PII, and counterfeit electronics? How can reductions in exports bolster job growth? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov.
    [Read More…]
  • Eighth Circuit Reverses Tax Court in Case Involving Statute of Limitations and Bona Fide Residency
    In Crime News
    The Eighth Circuit Court of Appeals issued a published opinion on Tuesday, Dec. 15, 2020, holding for the government in a case involving the statute of limitations on assessment in the context of bona fide residency in the U.S. Virgin Islands (USVI), announced Principal Deputy Assistant Attorney General Richard E. Zuckerman of the Justice Department’s Tax Division.
    [Read More…]
  • Border Security Metrics: Progress Made, but DHS Should Take Additional Steps to Improve Information Quality
    In U.S GAO News
    What GAO Found In its fiscal year 2019 Border Security Metrics Report , the Department of Homeland Security (DHS) reported information on 37 of the 43 metrics required by the National Defense Authorization Act for Fiscal Year 2017 (NDAA). As shown below, GAO found that 18 of the 37 metrics in the fiscal year 2019 report generally corresponded with their descriptions in the NDAA, while 19 metrics differed, such as in scope or calculation. How the Department of Homeland Security (DHS) Reported on the 43 Metrics Required by the National Defense Authorization Act for Fiscal Year 2017 (NDAA) DHS improved the quality of information in several metrics in the fiscal year 2019 report compared with earlier versions. However, data reliability issues remain—such as DHS not fully disclosing limitations of some metrics—because DHS does not have a process to systematically review the data. Implementing GAO's prior recommendations to develop and implement a process to systematically review the reliability of data—and communicate limitations identified through this process—would position DHS to maximize the quality of information and provide Congress and the public with contextual information needed to evaluate the metrics. DHS used a statistical model to estimate four metrics, including the estimated number of undetected unlawful entries between ports of entry. In response to one of GAO's prior recommendations, DHS, in its fiscal year 2019 Border Security Metrics Report , showed how the sensitivity of three assumptions affected the precision of the model's estimates. For example, the model assumed that DHS apprehends all families unlawfully crossing the border, and the fiscal year 2019 report outlined how this assumption affected the model-based metrics in 2018. This sensitivity analysis will allow Congress and the public to better understand the limitations of DHS's model and better evaluate the validity of border security metrics derived from it. In response to another GAO recommendation, DHS conveyed statistical uncertainty for one of the unlawful entry metrics in its fiscal year 2019 report. In particular, DHS outlined how this uncertainty might affect the model-based apprehension rate. However, DHS did not report how uncertainty would affect the other three metrics that rely on its statistical model. As GAO previously recommended, including measures of statistical uncertainty for all relevant metrics in future reports would allow Congress, policy makers, and the public to more fully evaluate the extent to which the metrics are valid. Why GAO Did This Study The United States has approximately 6,000 miles of land borders, 95,000 miles of coastline, and more than 300 ports of entry where travelers and cargo are inspected. Securing U.S. border areas is a key part of DHS's mission, and its ability to measure border security activities is essential to managing its responsibilities effectively and efficiently. The 2017 NDAA requires DHS to report annually on 43 border security metrics. The act also includes a provision for GAO, within 270 days of receipt of the first report and biennially for the following 10 years, to review and report on the data and methodology in DHS's report. GAO issued its initial report in March 2019. This second report evaluates the report DHS issued in August 2020, which is known as the fiscal year 2019 report and contains data through fiscal year 2018. This report addresses the extent to which DHS (1) reported metrics outlined in the 2017 NDAA using quality information and (2) has taken steps to determine and convey the sensitivity of key assumptions and the statistical uncertainty of its unlawful entry metrics. GAO assessed the methodology and data in DHS's report, analyzed DHS's use of statistical modeling, and interviewed officials from DHS offices and components.
    [Read More…]
  • Department Press Briefing – March 15, 2021
    In Crime Control and Security News
    Ned Price, Department [Read More…]

Crime

Network News © 2005 Area.Control.Network™ All rights reserved.