What GAO Found
The Federal Deposit Insurance Corporation (FDIC) has designed policies to address the risk of regulatory capture by reducing the potential benefit to industry of capturing the examination process, reducing avenues of inducement, and promoting a culture of independence and public service (see figure).
Framework for Reducing Risk and Minimizing Consequences of Regulatory Capture
FDIC has several policies for documenting bank examination decisions that help promote transparent decision-making and assign responsibility for decisions. Such policies are likely to help reduce benefits to industry of capturing the examination process. However, GAO found that some examinations were not implemented consistent with FDIC policies and that gaps in FDIC policies limited their effectiveness. For example, GAO found that managers sometimes did not clearly document how they concluded that banks had addressed recommendations. By improving adherence to agency policies, FDIC management could better address threats to capture in the examination process.
GAO found that FDIC has policies to address potential conflicts of interest that could help block or reduce avenues of inducement. For example, FDIC has post-employment conflict-of-interest policies designed to prevent former employees from exerting undue influence on FDIC and to reduce industry’s ability to induce current FDIC employees with prospective employment arrangements. One such policy requires the agency to review the workpapers of examiners-in-charge who accept employment with banks they examined in the prior 18 months. However, FDIC has not fully implemented a process for identifying when to review the workpapers of departing examiners to assess whether independence has been compromised. In particular, FDIC does not have a process for collecting information about departing employees’ future employment. By revising its examiner-departure processes, the agency could better identify when to initiate workpaper reviews.
FDIC has identified regulatory capture as a risk as part of its enterprise risk management process. The agency has documented 11 mitigation strategies that could help address that risk. Identified mitigation strategies include rotating examiners-in-charge, national examination training, and ethics requirements.
Why GAO Did This Study
FDIC supervises about 3,300 financial institutions to evaluate their safety and soundness. Some analyses by academic researchers have identified regulatory capture in supervision as one potential factor contributing to the 2007–2009 financial crisis. Regulatory capture is defined as a regulator acting in the interest of the regulated industry rather than in the public interest.
GAO was asked to review regulatory capture in financial regulation. This report examines FDIC’s (1) processes for encouraging transparency and accountability in the bank examination process, (2) processes to minimize potential conflicts of interest among examination staff, and (3) agency-wide efforts to address the risks of regulatory capture and compromised independence. GAO reviewed FDIC’s policies and enterprise risk management framework, analyzed bank examination workpapers, and interviewed supervisory staff.
What GAO Recommends
GAO is making four recommendations to FDIC related to managing the risk of regulatory capture, including improving documentation of banks’ progress at addressing FDIC recommendations and revising examiner-departure processes. FDIC neither agreed nor disagreed with these recommendations, but described actions it would take in response to them. FDIC’s actions, if fully implemented, would address two of the four recommendations.
For more information, contact Michael Clements at (202) 512-8678 or email@example.com.
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- Prescription Drugs: U.S. Prices for Selected Brand Drugs Were Higher on Average than Prices in Australia, Canada, and FranceBy Sam NewsApril 28, 2021What GAO Found GAO's analysis of 2020 data found that, for 20 selected brand-name prescription drugs, estimated U.S. prices paid at the retail level by consumers and other payers (such as insurers) were more than two to four times higher than prices in three selected comparison countries. The U.S. prices GAO estimated for comparison reflect confidential rebates and other price concessions, which GAO refers to as net prices. Publicly available prices for the comparison countries were gross prices that did not reflect potential discounts. As a result, the actual differences between U.S. prices and those of the other countries were likely larger than GAO estimates. The price differences varied by drug. Specifically, while estimated U.S. net prices were mostly higher than the gross prices in other countries (by as much as 10 times), some were lower. The following figure illustrates comparisons for two of GAO's selected drugs. GAO found similar differences in estimated prices paid by final payers at the manufacturer level. Estimated U.S. Net Prices and Selected Comparison Countries' Gross Prices at the Retail Level for Two Selected Drugs and Package Sizes, 2020 GAO's analysis found consumers' out-of-pocket costs for prescription drugs varied across and within all four countries but likely more within the U.S. and Canada where multiple payers had a role setting prices and designing cost-sharing for consumers, and not all consumers had prescription drug coverage. In Australia and France, prescription drug pricing was nationally regulated and prescription drug coverage was universal; thus, consumers' out-of-pocket costs within these countries for each drug were generally less varied. For example, in Australia, consumers typically paid one of two amounts for prescription drugs—either about 5 or 28 U.S. dollars in 2020. In the U.S., potential out-of-pocket costs for consumers could have varied much more widely depending on the type of coverage they had. For example, for one drug in GAO's analysis, considering only a few coverage options, consumers' out-of-pocket costs in 2020 could have ranged from a low of about 22 to a high of 514 U.S. dollars. GAO provided a draft to the Department of Health and Human Services for review and incorporated the Department's technical comments as appropriate. Why GAO Did This Study While spending on prescription drugs continues to grow worldwide, studies indicate the U.S. spends more than other countries. However, various factors—such as country-specific pricing strategies, confidential rebates to payers, and other price concessions—may obscure the actual prices of prescription drugs. GAO was asked to review U.S. and international prescription drug prices. This report (1) examines how prices at the retail and manufacturer levels in the U.S. compare to prices in three selected comparison countries—Australia, Canada, and France, and (2) provides information on consumers' out-of-pocket costs for prescription drugs in these countries. GAO analyzed 2020 price data for a non-generalizable sample of 41 brand-name drugs among those with the highest expenditures and use in the U.S. Medicare Part D program in 2017. Twenty of these drugs had price data available in all four countries. For U.S. prices, GAO estimated the net prices paid using data from various sources, including estimates of Medicare Part D rebates and other price concessions, and commercially available data. Prices for the selected comparison countries were obtained from publicly available government sources. National prices were not available for Canada, so GAO used the prices from Ontario, Canada's most populous province, as a proxy for Canadian prices. GAO also reviewed country-specific guidance and other relevant information and interviewed researchers, manufacturers, and government officials. For more information, contact John E. Dicken at (202) 512-7114 or firstname.lastname@example.org.[Read More…]
- Opioid Use Disorder: Treatment with Injectable and Implantable BuprenorphineBy Sam NewsAugust 4, 2020Of the medications used to treat opioid use disorder (OUD), only buprenorphine is both a controlled substance and available as an injection or implant. Buprenorphine is used to treat patients with OUD because it reduces or eliminates opioid withdrawal symptoms and blunts the euphoria or dangerous side effects of other opioids, such as heroin. When used to treat OUD, buprenorphine, in any form, is subject to additional laws and regulations that are overseen by the Drug Enforcement Administration (DEA), within the Department of Justice (DOJ) and the Substance Abuse and Mental Health Services Administration (SAMHSA), within the Department of Health and Human Services (HHS). To ensure patient safety when injectable and implantable buprenorphine is used, the Food and Drug Administration (FDA), within HHS has also required drug companies to establish risk evaluation and mitigation strategies to help ensure the benefits of these medications outweigh their risks. Providers and pharmacies must follow a number of specific steps based on federal requirements when providing treatment with injectable and implantable buprenorphine. Providers are responsible for prescribing, storing, and administering injectable and implantable buprenorphine, while pharmacies are responsible for dispensing these medications (see figure). Representatives GAO interviewed from provider groups and pharmacies said they did not find the steps involved in treating patients to be difficult overall. However, they stated that careful and timely coordination with each other and patients is needed at key steps of the process to ensure that the patient receives treatment. Representatives from provider groups and pharmacies reported that the risk of diversion of injectable and implantable buprenorphine is low. For example, all of the provider groups GAO spoke with said that diversion of injectable or implantable buprenorphine is unlikely, and representatives from three of the six provider groups said that the design of these formulations reduces opportunities for diversion due to how they are administered. Process for Treating Opioid Use Disorder with Injectable and Implantable Buprenorphine The use of injectable and implantable buprenorphine to treat OUD is relatively low compared to oral forms of buprenorphine. HHS has reported that about 7,250 prescriptions were issued for injectable and implantable buprenorphine in fiscal year 2019, compared to over 700,000 patients who received buprenorphine prescriptions for oral formulations to treat OUD or pain in that year. In 2018, SAMHSA estimated that about one-quarter of the estimated 2 million people with OUD had received some form of substance use treatment in the prior year. One form of treatment—medication-assisted treatment (MAT)— combines behavioral therapy with the use of certain medications. HHS has identified expanding access to treatment for OUD as an important strategy for reducing opioid morbidity and mortality, which includes increasing the number of injectable and implantable buprenorphine prescriptions. Congress included a provision in the SUPPORT Act for GAO to review access to and the potential for the diversion of controlled substances administered by injection or implantation. This report focuses on injectable and implantable controlled substances that can be used to treat OUD and specifically, describes the process for treating OUD with injectable and implantable buprenorphine and what is known about their use. GAO reviewed laws, regulations, and documentation from DEA, FDA, and SAMHSA governing the process of providing treatment with buprenorphine and interviewed officials from those agencies. GAO also interviewed representatives from stakeholder groups representing MAT providers; drug companies that manufacture injectable or implantable buprenorphine; and pharmacies that dispense these medications. HHS and DOJ reviewed a draft of this report, and GAO incorporated their technical comments, as appropriate. For more information, contact James Cosgrove at (202) 512-7114 or email@example.com.[Read More…]
- Department Press Briefing – February 5, 2021By Sam NewsFebruary 5, 2021Ned Price, Department [Read More…]
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- International Law Enforcement Operation Targeting Opioid Traffickers on the Darknet Results in over 170 Arrests Worldwide and the Seizure of Weapons, Drugs and over $6.5 MillionBy Sam NewsSeptember 22, 2020Today, the Department of Justice, through the Joint Criminal Opioid and Darknet Enforcement (JCODE) team joined Europol to announce the results of Operation DisrupTor, a coordinated international effort to disrupt opioid trafficking on the Darknet. The operation, which was conducted across the United States and Europe, demonstrates the continued partnership between JCODE and Europol against the illegal sale of drugs and other illicit goods and services. Operation DisrupTor builds on the success of last year’s Operation SaboTor and the coordinated law enforcement takedown of the Wall Street Market, one of the largest illegal online markets on the dark web.[Read More…]
- Indonesia Travel AdvisoryBy Sam NewsSeptember 26, 2020Do not travel Indonesia [Read More…]
- Public Designation of Oligarch and Former Ukrainian Public Official Ihor Kolomoyskyy Due to Involvement in Significant CorruptionBy Sam NewsMarch 5, 2021
- Nuclear Waste: Congressional Action Needed to Clarify a Disposal Option at West Valley Site in New YorkBy Sam NewsJanuary 13, 2021The Department of Energy (DOE) has made progress in cleaning up radioactive waste at the site of the West Valley Demonstration Project in New York State. In the 1960s and 1970s, a commercial facility at the site reprocessed spent (used) nuclear fuel into reusable nuclear material—creating various wastes that remained on-site after the facility closed in 1976. Since 2011, DOE has demolished 51 of 55 structures there and disposed of about 1.3 million cubic feet of low-level waste to off-site locations. It has also placed solidified high-level waste into interim on-site storage (see fig.). In addition, DOE has processed for interim on-site storage about 30,000 cubic feet of transuranic waste (which is contaminated with elements that have an atomic number greater than uranium). As of February 2020, DOE reported spending about $3.1 billion on contracted cleanup activities, but it cannot estimate the cleanup's final cost until it decides how it will address the remaining waste. High-Level Waste from the West Valley Demonstration Project in Interim On-Site Storage, March 2017 DOE has been unable to dispose of the high-level and transuranic wastes stored at West Valley because there are no facilities authorized to accept these wastes. DOE has identified two potential options for disposal of the transuranic waste: the federal Waste Isolation Pilot Plant in New Mexico and a commercial facility in Texas. However, the New Mexico facility is authorized to accept only waste from atomic energy defense activities, and DOE does not consider West Valley waste to be from atomic energy defense activities. Regarding the Texas facility, state regulations preclude disposal of the waste there. In 2017, DOE submitted to Congress a report on all disposal options, as required by the Energy Policy Act of 2005. Pursuant to this act, DOE must await action by Congress before making a final decision, and Congress has not yet acted. The West Valley Demonstration Project Act, enacted in 1980, requires DOE to assist with cleanup activities at the site of the nation's only commercial facility for reprocessing spent nuclear fuel. The site contained 600,000 gallons of liquid high-level waste, radioactively contaminated structures and soils, and buried radioactive waste. In 2011, DOE began the first phase of its decommissioning plan, which included demolishing above-ground structures and removing contaminated soils. The West Valley Reauthorization Act and the Senate Committee Report No. 116-48 included provisions for GAO to review progress on the cleanup at West Valley. GAO's report examines (1) the status of the cleanup and (2) DOE's options for disposing of the remaining radioactive waste. GAO reviewed DOE's data on cleanup costs and waste volumes and its decommissioning plans, as well as laws, regulations, and policies governing radioactive waste disposal. GAO also interviewed officials from DOE and the state of New York, as well as other stakeholders. Congress should consider taking action to provide a legal option for the disposal of West Valley's transuranic waste. For more information, contact Allison Bawden at (202) 512-3841 or BawdenA@gao.gov.[Read More…]
- Federal Rulemaking: Selected EPA and HHS Regulatory Analyses Met Several Best Practices, but CMS Should Take Steps to Strengthen Its AnalysesBy Sam NewsJanuary 19, 2021GAO reviewed 11 Executive Order (EO) 13771 rules—five significant Environmental Protection Agency (EPA) rules and six economically significant Department of Health and Human Services (HHS) rules. Seven of the 11 rules modified (i.e. repealed, amended, or delayed) existing rules (see table). GAO found that analyses for most of the seven rules monetized the same types of benefits and costs as analyses for the rules they modified, an indicator of consistency in the regulatory analyses. For example, one EPA rule modified an earlier rule that had established requirements for chemical risk management programs. EPA monetized anticipated changes to industry compliance costs for both rules. Where agencies monetized similar types of benefits and costs for both reviewed rules and modified rules, the value of some estimates differed, in part, because agencies had updated analytical assumptions, such as the number of entities subject to requirements or relevant wage data. Topics and Characteristics of 11 Environmental Protection Agency (EPA) and Department of Health and Human Services (HHS) Rules Selected for Review Agency Topics Modified existing rule(s) Monetized costs exceeded benefits EPA Risk management programs ● ○ Railroad ties as non-waste fuels ● ○ Chemical data reporting ● ● Mercury reporting ○ ● Effluent from dental offices ○ ● HHS, FDA Food labeling ● ○ Agricultural water requirements ● ● HHS, CMS End-stage renal disease treatment ● ● Home health quality reporting ● ● Patient discharge planning ○ ● Diabetes prevention and appropriate use of imaging services ○ ● Legend: ● = Yes; ￮ = No Source: GAO analysis of EPA, Food and Drug Administration (FDA), and Centers for Medicare & Medicaid Services (CMS) data. | GAO-21-151 Regulatory analyses for eight of the 11 rules GAO reviewed projected that monetized costs would exceed monetized benefits, though each identified other factors that may have led decision makers to determine that the total benefits justified the total costs, such as important, non-quantified effects. These eight analyses met about half of the selected best practices for economic analysis. However, some analyses developed by HHS's Centers for Medicare & Medicaid Services (CMS) did not fully meet best practices associated with analyzing regulatory alternatives, assessing important effects, and providing transparency. It is particularly important that agencies develop quality analyses for economically significant rules, such as those finalized by CMS. By meeting these best practices, CMS could help the public and other parts of government provide effective feedback and mitigate potential conflict with entities affected by rules. It could also help CMS assess whether a rule's benefits justify the costs. EO 13771 generally requires executive agencies to identify two rules for repeal for each new rule issued. Since EO 13771 went into effect in 2017, executive agencies have taken regulatory actions expected to generate over $50 billion in savings to society. Quality regulatory analysis provides agency decision makers and the public with a thorough assessment of the benefits and costs of different regulatory options. GAO was asked to review regulatory analyses for rules finalized under EO 13771. For selected agencies, this report examines (1) how the calculated economic effects of selected rules differed, if at all, from those of rules they modified; and (2) the extent to which agencies met best practices in analyzing the economic effects of selected rules for which monetized costs exceed monetized benefits. GAO reviewed analyses for 11 rules—and the rules they modified— finalized by EPA and HHS, the two agencies that finalized the most economically significant EO 13771 rules through fiscal year 2019. GAO compared analyses to selected best practices in GAO's Assessment Methodology for Economic Analysis . GAO recommends that CMS take steps to ensure its future regulatory analyses are consistent with best practices for analyzing alternatives, assessing important effects, and providing transparency. EPA said it appreciated GAO's findings. HHS generally agreed with the report, and CMS agreed with the recommendation directed to it. For more information, contact Yvonne D. Jones at (202) 512-6806 or firstname.lastname@example.org.[Read More…]
- Cameroonian Citizen Extradited from Romania to Face Covid-19-Related Fraud ChargesBy Sam NewsApril 27, 2021A citizen of Cameroon was extradited to the U.S. yesterday to face federal charges for his alleged involvement in a fraud scheme perpetrated against American consumers.[Read More…]