Antony J. Blinken, Secretary of State
Forty years ago, on June 5th, the Centers for Disease Control and Prevention reported on the first five cases of what later became known as AIDS. At that time, none of us could have imagined that AIDS would still be with us today or that it would have taken more than 32 million lives globally, including 700,000 in the United States.
Today, we honor the memory of these men, women, and children, many of whom we lost in the prime of their lives to this devastating disease. We also celebrate the more than 38 million people worldwide, including 1.2 million in the United States, who are bravely living with HIV.
The United States is proud of our longstanding partnership with countries and communities around the world toward ending the global AIDS epidemic. We continue to bring the very best of America to this effort – from groundbreaking scientific discovery and inspired activism to steadfast political leadership and deep diplomatic engagement.
With bipartisan support across presidential administrations and from the U.S. Congress for nearly two decades, the United States has invested more than $85 billion in the global AIDS response through the President’s Emergency Plan for AIDS Relief (PEPFAR) and as the leading donor to the Global Fund to Fight AIDS, Tuberculosis and Malaria. This is the largest commitment ever by one country to address a single disease.
Working with our many partners, we have saved more than 20 million lives, prevented millions of HIV infections, and significantly accelerated progress toward achieving HIV epidemic control in more than 50 countries. PEPFAR now supports nearly 18.2 million people with lifesaving antiretroviral therapy – an additional one million in the past six months alone. PEPFAR investments also assist nearly 300,000 health care workers, 3,000 laboratories, 70,000 health care sites, and disease surveillance – strengthening country capacity and resilience to prevent, detect, and respond to other infectious disease threats, including COVID-19.
Forty years on, we must take this important moment to reflect, recommit, reenergize, and reengage. After decades of progress, our work is not yet finished. To complete this journey – one started by the courageous advocates who marched in the streets of New York City, San Francisco, and across America – we must come together as a nation and as a global community. It is time to end the HIV epidemic everywhere.
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- COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use AuthorizationsBy Sam NewsNovember 17, 2020Through Operation Warp Speed—a partnership between the Department of Health and Human Services (HHS) and the Department of Defense (DOD)—the federal government is accelerating efforts to develop vaccines and therapeutics for COVID-19. A typical vaccine development process can take approximately 10 years or longer, but efforts under Operation Warp Speed seek to greatly accelerate this process by completing key steps simultaneously (see figure). As of October 15, 2020, Operation Warp Speed publicly announced financial support for the development or manufacturing of six COVID-19 vaccine candidates totaling more than $10 billion in obligations. It has also announced financial support for the development of therapeutics, such as a $450 million award to manufacture a monoclonal antibody treatment (a treatment that uses laboratory-made antibodies, which also may be able to serve as a prevention option). Operation Warp Speed Timeline for a Potential Vaccine Candidate Note: An Emergency Use Authorization allows for emergency use of medical products without FDA approval or licensure during a declared emergency, provided certain statutory criteria are met. The Food and Drug Administration (FDA) may temporarily allow the use of unlicensed or unapproved COVID-19 vaccines and therapeutics through emergency use authorizations (EUA), provided there is evidence that the products may be effective and that known and potential benefits outweigh known and potential risks. For vaccines, FDA issued guidance in October 2020 to provide vaccine sponsors with recommendations regarding the evidence FDA needed to support issuance of an EUA. For therapeutics, FDA has issued four EUAs as of November 9, 2020. The evidence to support FDA's COVID-19 therapeutic authorization decisions has not always been transparent, in part because FDA does not uniformly disclose its scientific review of safety and effectiveness data for EUAs, as it does for approvals for new drugs and biologics. Given the gravity of the pandemic, it is important that FDA identify ways to uniformly disclose this information to the public. By doing so, FDA could help improve the transparency of, and ensure public trust in, its EUA decisions. The U.S. had about 10.3 million cumulative reported cases of COVID-19 and about 224,000 reported deaths as of November 12, 2020. Given this catastrophic loss of life as well as the pandemic's effects on the U.S. economy, effective and safe vaccines and therapeutics are more important than ever. 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, (1) efforts of Operation Warp Speed to accelerate COVID-19 vaccine and therapeutic development; and (2) FDA's use of EUAs for COVID-19 therapeutics and vaccines, among other objectives. GAO reviewed federal laws and agency documents, including HHS and DOD information on vaccine and therapeutic development and EUAs as of November 2020. GAO interviewed or received written responses from HHS and DOD officials, and interviewed representatives from vaccine developers and manufacturers, as well as select public health stakeholders and provider groups covering a range of provider types. FDA should identify ways to uniformly disclose to the public the information from its scientific review of safety and effectiveness data when issuing EUAs for therapeutics and vaccines. HHS neither agreed nor disagreed with the recommendation, but said it shared GAO's goal of transparency and would explore approaches to achieve this goal. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or firstname.lastname@example.org, or Alyssa M. Hundrup at (202) 512-7114 or email@example.com.[Read More…]
- Retirement Security: DOL Could Better Inform Divorcing Parties About Dividing SavingsBy Sam NewsAugust 28, 2020Although more than one-third of adults aged 50 or older have experienced divorce, few people seek and obtain a Qualified Domestic Relations Order (QDRO), according to large plan sponsors GAO surveyed. A QDRO establishes the right of an alternate payee, such as a former spouse, to receive all or a portion of the benefits payable to a participant under a retirement plan upon separation or divorce. There are no nationally representative data on the number of QDROs, but plans and record keepers GAO interviewed and surveyed reported that few seek and obtain QDROs. For example, the Pension Benefit Guaranty Corporation administered retirement benefits to about 1.6 million participants, and approved about 16,000 QDROs in the last 10 years. GAO's analysis of other survey data found about one-third of those who experienced a divorce from 2008 to 2016 and reported their former spouse had a retirement plan also reported losing a claim to that spouse's benefits. Many experts stated that some people—especially those with lower incomes—face challenges to successfully navigating the process for obtaining a QDRO, including complexity and cost. Individuals seeking a QDRO may be charged fees for preparation and review of draft orders before they are qualified as QDROs and, according to experts GAO interviewed, these fees vary widely. These experts cited concerns about QDRO review fees that they said in some cases were more than twice the amount of typical fees, and said they may discourage some from pursuing QDROs. Department of Labor (DOL) officials said the agency generally does not collect information on QDRO fees. Exploring ways to collect and analyze information from plans on fees could help DOL ensure costs are reasonable. Divorcing parties who pursue QDROs often had orders not qualified due to lacking basic information, according to plans and record keepers we surveyed (see figure). Plan Administrators and Record Keepers Reported Reasons for Not Qualifying a Domestic Relations Order (DRO) DOL provides some information to help divorcing parties pursue QDROs. However, many experts cited a lack of awareness about QDROs by the public and said DOL could do more to make resources available to divorcing parties. Without additional outreach by DOL, divorcing parties may spend unnecessary time and resources drafting orders that are not likely to be qualified, resulting in unnecessary expenditures of time and money. A domestic relations order (DRO) is a court-issued judgment, decree, or order that, when qualified by a retirement plan administrator, can divide certain retirement benefits in connection with separation or divorce and as such provide crucial financial security to a former spouse. DOL has authority to interpret QDRO requirements. GAO was asked to review the process for obtaining QDROs. This report examines what is known about (1) the number of QDRO recipients, (2) the fees and other expenses for processing QDROs, and (3) the reasons plans do not initially qualify DROs and the challenges experts identify regarding the QDRO process. To conduct this work, GAO analyzed available data, and a total of 14 responses from two surveys of large private sector plans and account record keepers, and interviewed 18 experts including practitioners who provide services to divorcing couples. GAO is recommending that DOL (1) explore ways to collect information on QDRO-related fees charged to participants or alternate payees, and (2) take steps to ensure information about the process for obtaining a QDRO is accessible. DOL generally agreed with our recommendations. For more information, contact Kris Nguyen at (202) 512-7215 or NguyenTT@gao.gov.[Read More…]
- Priority Open Recommendations: Office of Personnel ManagementBy Sam NewsJuly 8, 2021What GAO Found In April 2020, GAO identified 18 priority recommendations for the Office of Personnel Management (OPM). Since then, OPM has implemented four of those recommendations by, among other things, taking actions to collect and share agencies’ information on mission critical occupations as well as hiring data; sharing key practices and lessons learned, including how to address employee misconduct; and implementing a quality assurance review process to re-evaluate security control assessments. We are not adding any new priority recommendations this year. The total number of priority recommendations remaining is 14. These recommendations involve the following areas: improving the federal classification system; making hiring and special pay authorities more effective; improving Enterprise Human Resource Integration payroll data; addressing employee misconduct and improving performance management; and strengthening IT security and management. OPM’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 Alissa Czyz, Acting Director, Strategic Issues at 202-512-6806 or CzyzA@gao.gov.[Read More…]
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- Contractor Business Systems: DOD Needs Better Information to Monitor and Assess Review ProcessBy Sam NewsAugust 24, 2021What GAO Found Since 2011, the Department of Defense (DOD) has implemented several changes to its processes for reviewing contractor business systems—which include systems such as accounting, estimating, and purchasing. Among other changes, DOD clarified the roles and responsibilities of the Defense Contract Management Agency (DCMA) and the Defense Contract Audit Agency (DCAA)—the two agencies that are responsible for conducting the reviews; clarified timeframes for business system reviews and established criteria for business systems; and withheld payments from contractors that were found to have significant deficiencies in their business systems. DOD does not have a mechanism to monitor and ensure that these reviews are being conducted in a timely manner. For its part, DCAA has conducted few business system audits since 2013, as it focused its efforts on other types of audits. DCAA plans to significantly increase the number of business system audits over the next 4 years, but its success in doing so depends on its ability to shift resources from other audits; to use public accounting firms to conduct other, non-business system audits; and DCAA staff's ability to execute new audit plans in a timely manner. DCMA relies on the three offices responsible for conducting DCMA-led reviews to manage the reviews, but DCMA does not formally monitor whether these reviews are being conducted consistent with policy nor does it monitor DCAA's efforts to complete the audits for which it is responsible. DCMA is ultimately responsible for approving a contractor's business systems. DCMA currently lacks a mechanism based on relevant and reliable information, such as the number of reviews that are outstanding and the resources available to conduct such reviews, to ensure reviews are being completed in a timely fashion. Such information could help inform more strategic oversight on whether the current review process is achieving its intended results, or whether additional changes to the timing of or criteria for conducting reviews are needed. Why GAO Did This Study Contractor business systems produce critical data that contracting officers use to help negotiate and manage defense contracts. These systems and their related internal controls act as important safeguards against fraud, waste, and abuse of federal funding. Federal and defense acquisition regulations and DOD policies require that DOD take steps to review the adequacy of certain business systems, but GAO and other oversight entities have raised questions about the sufficiency and consistency of DOD's review process. The National Defense Authorization Act for Fiscal Year 2018 contained a provision for GAO to evaluate how DOD implemented legislation intended to improve its business system review process. Among other things, this report examines (1) the changes DOD made to its review process and (2) the extent to which DOD is ensuring timely business system reviews. GAO analyzed DOD acquisition regulations, policies, and procedures for conducting contractor business system reviews and analyzed data on reviews conducted between fiscal years 2013 and 2018.[Read More…]
- Nuclear Security Enterprise: NNSA Should Use Portfolio Management Leading Practices to Support Modernization EffortsBy Sam NewsJune 10, 2021What GAO Found The National Nuclear Security Administration (NNSA) has partially implemented selected leading practices to manage the work necessary to maintain and modernize the nation's nuclear weapons stockpile. GAO found that NNSA is in the early stages of initiating its portfolio management processes and has partially implemented leading practices, such as establishing a clearly defined portfolio of work. For example, NNSA officials stated that its Weapons Activities appropriations account is a portfolio of work. However, NNSA has not developed clearly defined and appropriately empowered governance roles, such as a portfolio manager, for its Weapons Activities portfolio. As NNSA continues to develop its approach to portfolio management, establishing a portfolio management framework—consistent with selected leading practices—may allow NNSA to fully implement all leading practices, better define how program offices will pursue strategic stockpile modernization objectives, and optimize portfolio performance in the event that budget trade-offs become necessary. NNSA's offices have undertaken four separate efforts to identify and assess the capabilities needed across the nuclear security enterprise to meet its stockpile maintenance and modernization mission, but NNSA has not developed a comprehensive or complete capability assessment that could support its portfolio management approach (see fig.). NNSA undertook three of these four independent efforts to identify and assess capabilities in response to different legislative direction and did not incorporate information on all elements of a capability (knowledge, human capital, and infrastructure) in any of the individual efforts. Working across the agency to conduct a comprehensive, complete capability assessment would provide NNSA with a portfolio-level view of the enterprise's capabilities and needs, allowing for planning that considers interdependencies that have been missed in the past when planning focused on individual programs or projects. Relationship between Capability Assessment and Portfolio Management Why GAO Did This Study NNSA is simultaneously modernizing the nation's nuclear weapons stockpile and the infrastructure on which weapons research and production programs depend. These efforts include multi-billion-dollar defense programs and projects that provide the capabilities needed for maintenance and modernization programs. Congress previously directed NNSA to identify its needed capabilities. The Senate report accompanying the National Defense Authorization Act for Fiscal Year 2020 includes a provision for GAO to review NNSA's approach to managing its defense programs and to identifying capabilities. This report examines the extent to which NNSA (1) used selected portfolio management leading practices to manage its maintenance and modernization programs and projects and (2) developed a comprehensive and complete capability assessment to support portfolio management. GAO reviewed NNSA documentation related to portfolio management and capabilities and compared it with leading practices and legislative requirements. GAO also interviewed NNSA officials from six agency offices.[Read More…]
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