Public Health Preparedness: HHS Has Taken Some Steps to Implement New Authority to Speed Medical Countermeasure Innovation

What GAO Found

The Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority has taken steps towards implementing an authority provided by the 21st Century Cures Act to accelerate the development of medical countermeasures. Medical countermeasures are drugs, vaccines, and devices to diagnose, treat, prevent, or mitigate potential health effects of exposure to chemical, biological, radiological, and nuclear threats. However, as of June 2020, HHS had not selected a medical countermeasures innovation partner—an independent, nonprofit entity that the 21st Century Cures Act authorizes HHS to partner with to use venture capital practices and methods to invest in companies developing medical countermeasures. Towards implementing the authority, HHS has

  • developed a vision for the innovation partner,
  • staffed a division to manage HHS’s medical innovation partnership and determined an initial amount of funding needed,
  • solicited and considered feedback from venture capital and other stakeholders, and
  • developed preliminary plans for structuring and overseeing the partnership.

HHS officials explained this type of partnership approach was new to the agency and required due diligence to develop. According to agency officials, the innovation partner will allow HHS to invest in potentially transformative medical countermeasures that have the potential to benefit the government. For example, the innovation partner could invest in innovative wearable technologies to help early detection of viral infections. HHS officials told GAO that the partner, which is required by law to be a nonprofit entity, will be required to reinvest BARDA’s revenues generated from government investments into further investments made through the partnership. BARDA’s ultimate goal will be to use these revenues to fund new investments.

According to a review of stakeholder comments submitted to HHS, potential venture capital partners identified concerns regarding aspects of the agency’s plans for the innovation partner, which the stakeholders indicated could hinder HHS’s implementation of the authority. For example, there is a statutory limit to the annual salary that can be paid to an individual from HHS’s annual appropriation, which some stakeholders indicated was too low to attract an entity to manage the innovation partner funds. HHS officials told GAO they are assessing options to mitigate some of these concerns, but that plans will not be final until they select the partner.

GAO provided a draft of this correspondence to HHS and the Department of Defense for review and comment. HHS did not provide comments on this report and DOD provided technical comments that we incorporated as appropriate.

Why GAO Did This Study

The COVID-19 pandemic and other public health emergencies caused by chemical, biological, radiological, and nuclear agents or emerging infectious diseases raise concern about the nation’s vulnerability to, and capacity to prevent or mitigate, potential health effects from exposure to such threats. The 21st Century Cures Act authorized HHS to partner with a private, nonprofit entity that can use venture capital practices and methods to invest in companies developing promising, innovative, medical countermeasures. The 21st Century Cures Act included a provision for GAO to review activities conducted under the innovation partner authority.

This report describes the status of HHS’s implementation of the authority. GAO reviewed relevant statutes and HHS documentation regarding its plans and actions taken to implement the authority, reviewed responses HHS received to the two requests for information it used to collect information from venture capital and other stakeholders, interviewed HHS officials, and interviewed officials from the Department of Defense, which has partnered with a private, nonprofit entity to make investments using venture capital practices.

For more information, contact Mary Denigan-Macauley at (202) 512-7114 or DeniganMacauleyM@gao.gov.

Hits: 2

News Network

  • Office for Victims of Crime Awards Nearly $4 Million to Support Sexual Assault Nurse Examiner Programs
    In Crime News
    The Office of Justice [Read More…]
  • Announcing Sanctions on the Ortega Regime in Response to Arbitrary Detentions and Other Undemocratic Moves
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • Columbia Class Submarine: Delivery Hinges on Timely and Quality Materials from an Atrophied Supplier Base
    In U.S GAO News
    The Navy's schedule for constructing the first submarine of the new Columbia class is threatened by continuing challenges with the computer-aided software tool that Electric Boat, the lead shipbuilder, is using to design the submarine. These challenges will likely impede construction because the shipbuilder is late in completing design products used for building the submarine. To ensure construction begins on schedule, the Navy modified its design contract with Electric Boat to include an option for constructing the first two submarines and requested sufficient authority from Congress for fiscal year 2021 to exercise it. Navy officials stated, however, that the Navy's budget request is lower than its current cost estimate, and it is not informed by an independent cost assessment. As a result, the program will likely need more funding to reflect the increased estimate. Quality problems with supplier materials caused delays during early construction. These quality problems included missile tubes (depicted below) with defective welds. As the shipbuilders expand outsourcing to suppliers, quality assurance oversight at supplier facilities will be critical for avoiding further delays. Quad Pack of Four Submarine Missile Tubes However, the Navy has not comprehensively reassessed when to seek additional inspections at supplier facilities that could better position it to identify quality problems early enough to limit delays. The Navy plans to invest about $128 billion in 12 Columbia class nuclear-powered ballistic missile submarines. The shipbuilders will construct the Columbia class at the same time as the Virginia class attack submarines. They plan to rely on materials produced by a supplier base that is roughly 70 percent smaller than in previous shipbuilding booms. Congress included a provision in statute for GAO to examine the program's status. This report assesses the Navy's efforts to complete the design for the lead Columbia class submarine and actions the shipbuilders and the Navy have taken to prepare for construction and ensure the lead submarine is delivered according to schedule and quality expectations. GAO assessed Navy and shipbuilder design progress against cost and schedule estimates, reviewed documents, and interviewed officials about supplier readiness and quality assurance. This is a public version of a sensitive report that GAO issued in November 2020. Information that the Department of Defense (DOD) deemed sensitive has been omitted. GAO recommends that the Navy (1) provide Congress with updated cost information, (2) include information on supplier readiness in its annual report to Congress, and (3) reassess when to seek additional inspections at supplier facilities. DOD concurred with the recommendations but disagreed with some of the report's details. GAO incorporated DOD's comments as appropriate and maintains the validity of the findings, as discussed in the report. For more information, contact Shelby S. Oakley at (202) 512-4841 or oakleys@gao.gov.
    [Read More…]
  • U.S. Attorney Transition Begins
    In Crime News
    Continuing the practice of new administrations, President Biden and the Department of Justice have begun the transition process for the U.S. Attorneys.
    [Read More…]
  • Military Housing: DOD Has Taken Key Steps to Strengthen Oversight, but More Action Is Needed in Some Areas
    In U.S GAO News
    In 1996 Congress provided DOD with authorities enabling it to obtain private-sector financing and management to repair, renovate, construct, and operate military housing. DOD has since privatized about 99 percent of its domestic housing. The Department of Defense (DOD) has made progress in addressing weaknesses in its privatized housing program, and GAO has identified additional opportunities to strengthen the program. GAO reported in March 2020 on DOD's oversight and its role in the management of privatized housing. Specifically, GAO found that 1) the military departments conducted some oversight of the physical condition of privatized housing, but some efforts were limited in scope; 2) the military departments used performance metrics to monitor private developers, but the metrics did not provide meaningful information on the condition of housing; 3) the military departments and private developers collected maintenance data on homes, but these data were not captured reliably or consistently, and 4) DOD provided reports to Congress on the status of privatized housing, but some data in these reports were unreliable, leading to misleading results. GAO made 12 recommendations, including that DOD take steps to improve housing condition oversight, performance indicators, maintenance data, and resident satisfaction reporting. DOD generally concurred with the recommendations. As of February 2021, DOD fully implemented 5 recommendations and partially implemented 7 recommendations. DOD should also take action to improve the process for setting basic allowance for housing (BAH)—a key source of revenue for privatized housing projects. In January 2021, GAO reported on DOD's process to determine BAH. GAO found that DOD has not always collected rental data on the minimum number of rental units needed to estimate the total housing cost for certain locations and housing types. Until DOD develops ways to increase its sample size, it will risk providing housing cost compensation that does not accurately represent the cost of suitable housing for servicemembers. GAO recommended that DOD review its methodology to increase sample sizes. GAO has also determined, in a report to be issued this week, that DOD should improve oversight of privatized housing property insurance and natural disaster recovery. GAO assessed the extent to which the military departments and the Office of the Secretary of Defense exercise oversight of their projects' insurance coverage. GAO found that the military departments have exercised insufficient oversight, and that the Office of the Secretary of Defense has not regularly monitored the military departments' implementation of insurance requirements. Without establishing procedures for timely and documented reviews, the military departments cannot be assured that the projects are complying with insurance requirements and assuming a proper balance of risk and cost. The draft of this report, which GAO provided to DOD for official comment, included 9 recommendations, 2 of which DOD addressed in January 2021 by issuing policy updates. The final report's 7 remaining recommendations, including that the military departments update their respective insurance review oversight procedures, will help strengthen DOD's oversight of privatized housing, once implemented. DOD concurred with all of the recommendations. Congress enacted the Military Housing Privatization Initiative (MHPI) in 1996 to improve the quality of housing for servicemembers. DOD is responsible for general oversight of privatized housing projects. Private-sector developers are responsible for the ownership, construction, renovation, maintenance, and repair of about 99 percent of military housing in the United States. GAO has conducted a series of reviews of MHPI, following reports of hazards (such as mold) in homes, questions about DOD's process to determine the basic allowance for housing rates, which is a key revenue source for privatized housing, and concerns about how DOD ensures appropriate property insurance for privatized housing projects impacted by severe weather. This statement summarizes 1) steps DOD has taken to strengthen oversight and management of its privatized housing program, and work remaining; 2) actions needed to improve DOD's BAH process; and 3) actions needed to enhance DOD's oversight of privatized housing property insurance. The statement summarizes two of GAO's prior reports, and a report to be issued, related to privatized housing. For this statement, GAO reviewed prior reports, collected information on recommendation implementation, and interviewed DOD officials. In prior reports, GAO recommended that DOD improve oversight of housing conditions; review its process for determining basic allowance for housing rates; and that the military departments update their housing insurance review oversight procedures. For more information, contact Elizabeth A. Field at (202) 512-2775 or fielde1@gao.gov.
    [Read More…]
  • U.S.-Bulgaria Sign Nuclear Cooperation Memorandum of Understanding
    In Crime Control and Security News
    Office of the [Read More…]
  • U.S. Businesses Must Take a Stand Against China’s Human Rights Abuses
    In Human Health, Resources and Services
    Keith Krach, Under [Read More…]
  • Oil and Gas: Onshore Competitive and Noncompetitive Lease Revenues
    In U.S GAO News
    Pursuant to federal law, the Department of the Interior's (Interior) Bureau of Land Management (BLM) offers leases competitively through auction or noncompetitively for a fee if an adequate bid is not received. Competitive leases for oil and gas development on federal lands produced greater revenues, on average, than noncompetitive leases for fiscal years 2003 through 2019, according to GAO's analysis of revenues reported by Interior's Office of Natural Resources Revenue (ONRR) and leases from BLM. For this period, about 72,800 competitive leases produced about $14.3 billion in revenues—while total of 100,300 leases produced $16.1 billion. Average revenues from competitive leases over this time period were nearly 3 times greater than revenues from noncompetitive leases; about $196,000 and $66,000, respectively. Based on GAO's analysis of leases that started in fiscal years 2003 through 2009, competitive leases produced oil and gas more often than noncompetitive leases during the leases' 10-year primary term. Further, competitive leases with high bonus bids (bids above $100 per acre) were more likely to produce oil and gas in their 10-year primary terms than both competitive leases with lower bonus bids and noncompetitive leases. Specifically, about 26 percent of competitive leases that sold with bonus bids above $100 per acre produced oil and gas and generated royalties in their primary term compared with about 2 percent for competitive leases that sold at the minimum bid of $2 per acre and about 1 percent for noncompetitive leases. GAO's analysis showed that competitive leases with high bonus bids generated over 3 times the amount of cumulative, or total, royalties by the end of their primary term than all other competitive and noncompetitive leases combined (see fig.). Cumulative Royalties from Competitive Leases, by Bonus Bid, and Noncompetitive Leases That Started in Fiscal Years 2003 through 2009 According to BLM, federal onshore oil and gas leases generate about $3 billion annually in federal revenues, including royalties, one-time bonus bid payments, and rents. The Federal Onshore Oil and Gas Leasing Reform Act of 1987 requires that public lands available for oil and gas leasing first be offered under a competitive bidding process. BLM offers leases with 10-year primary terms competitively through auction or, if the tract of land does not receive an adequate bid, noncompetitively for a fee. The minimum bid is $2 per acre, and bids at or above the minimum are called bonus bids. ONRR is to collect revenues from oil and gas leases in accordance with the specific terms and conditions outlined in the leases, including revenues from rents and royalties. Lessees are to pay rent annually until production begins on the leased land and then pay royalties as a percentage of oil and gas production. Lease terms may be extended beyond the primary term if, for example, the lease is producing oil or gas. GAO was asked to review oil and gas leasing on federal lands. This report describes oil and gas revenues from competitive and noncompetitive leases for fiscal years 2003 through 2019. GAO analyzed federal lease and revenue data and interviewed Interior officials and four experts knowledgeable about federal oil and gas leasing. To consistently compare leases over their lifecycle, GAO analyzed revenues that occurred within the leases' primary term (first 10 years) for leases that started in fiscal years 2003 through 2009. For more information, contact Frank Rusco at (202) 512-3841 or RuscoF@gao.gov.
    [Read More…]
  • Secretary Blinken’s Meeting with the C5+1
    In Crime Control and Security News
    Office of the [Read More…]
  • Former Air Force Contractor Pleads Guilty to Illegally Taking 2,500 Pages of Classified Information
    In Crime News
    A former contractor with the U.S. Air Force pleaded guilty in the U.S. District Court, Southern District of Ohio today to illegally taking approximately 2,500 pages of classified documents.
    [Read More…]
  • Joint Statement on Hong Kong
    In Crime Control and Security News
    Office of the [Read More…]
  • Former Energy Broker Pleads Guilty to Insider Trading and Kickback Scheme
    In Crime News
    A former Texas energy broker pleaded guilty Monday to conspiracy to commit commodities fraud and wire fraud and to violate various provisions of the Commodity Exchange Act for his role in an insider trading and kickback scheme. 
    [Read More…]
  • Justice Department Warns Taxpayers to Avoid Fraudulent Tax Preparers
    In Crime News
    With less than one month left in this year’s tax season, the Department of Justice urges taxpayers to choose their return preparers wisely. Return preparer fraud is one of the IRS’ Dirty Dozen Tax Scams. Unscrupulous preparers who include errors or false information on a customer’s return could leave a taxpayer open to liability for unpaid taxes, penalties, and interest.
    [Read More…]
  • Arkansas RV Salesman Indicted for Income Tax Evasion
    In Crime News
    An indictment was unsealed today charging an Arkansas man with three counts of evading his individual income taxes.
    [Read More…]
  • Former Deputy Campaign Manager Pleads Guilty to Theft of Campaign Funds
    In Crime News
    An Illinois man pleaded guilty today to the theft of more than $115,000 in campaign funds from the McSally for Senate Campaign in 2018 and 2019.
    [Read More…]
  • On Lunar New Year
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • Secretary Blinken’s Call with Indian External Affairs Minister S. Jaishankar
    In Crime Control and Security News
    Office of the [Read More…]
  • Organ Transplants: Changes in Allocation Policies for Donated Livers and Lungs
    In U.S GAO News
    The Organ Procurement and Transplantation Network (OPTN) develops allocation policies in the United States to determine which transplant candidates receive offers for organs, such as livers or lungs, that are donated from deceased donors. In July 2018, the Department of Health and Human Services (HHS), which oversees OPTN, directed it to change the liver allocation policy to be more consistent with federal regulations. The liver allocation policy changed in February 2020 from a system that, in general, offered donated livers first to the sickest candidates within the fixed boundaries of a donation service area or region to a system based on a candidate's level of illness and distance from the donor hospital. The current liver allocation policy offers livers first to the sickest candidates within 500 nautical miles of the donor hospital using a series of distance-based concentric circles, called acuity circles. The processes used to develop the liver and lung allocation policies had various similarities and differences. For example, while the current liver allocation policy, the 2017 liver allocation policy, and the current lung allocation policy each had public comment periods, the length of these comment periods varied—25 days for the current liver allocation policy; two separate 62-day and 64-day periods for the 2017 liver allocation policy; and 61 days (retroactive) for the current lung allocation policy. In addition, the current lung allocation policy resulted in part from a federal district court order directing HHS to initiate emergency review of the policy. However, the 2017 liver allocation policy—that was approved but never implemented—resulted from a 2012 OPTN Board directive to reduce geographic disparities in organ allocation. HHS oversight of OPTN's processes were similar for all three allocation policies and included reviewing the proposed changes to the policies to ensure compliance with federal regulations, according to HHS officials. Timeline of Selected Events Related to Three Organ Allocation Policies Organ transplantation is the leading form of treatment for patients with severe organ failure. OPTN, a nonprofit entity that was established in 1984 under the National Organ Transplant Act, manages the nation's organ allocation system. In 2019, 32,322 organs were transplanted from deceased donors in the United States. Nevertheless, as of July 2020, close to 110,000 individuals remained on waiting lists for donor organs. Previously, donated livers and lungs were generally offered first to the sickest candidates in donation service areas. However, livers and lungs are now generally offered first to the sickest candidates based on distance. GAO was asked to review the changes to the liver and lung allocation policies. This report describes (1) changes to the liver allocation policy, and (2) similarities and differences in the processes OPTN used to change the liver and lung allocation policies, and federal oversight of these processes, among other things. GAO reviewed documents, including those related to the current liver and lung allocation policies, and the 2017 liver allocation policy; interviewed HHS officials and OPTN members; reviewed the National Organ Transplant Act and its implementing regulations; and conducted a literature review of studies published from January 2017 through April 2020 in peer-reviewed and other publications. HHS and the United Network for Organ Sharing (the contractor serving as OPTN) provided technical comments on a draft of this report, which GAO incorporated as appropriate. For more information, contact James Cosgrove at (202) 512-7114 or cosgrovej@gao.gov.
    [Read More…]
  • Joint Statement from the Departments of Justice and Homeland Security Assessing the Impact of Foreign Interference During the 2020 U.S. Elections
    In Crime News
    The Department of Justice (DOJ), and the Department of Homeland Security (DHS), including the FBI and the Cybersecurity and Infrastructure Security Agency (CISA), released today key findings and recommendations from a joint report to the President issued last month on the impact of foreign governments and their agents on the security and integrity of the 2020 U.S. federal elections.
    [Read More…]
  • U.S.-Sudan Signing Ceremony on Bilateral Claims Agreement
    In Crime Control and Security News
    Cale Brown, Deputy [Read More…]
  • Hong Kong Autonomy Act Update
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • Secretary Blinken to Deliver Remarks to the Media in the Press Briefing Room
    In Crime Control and Security News
    Office of the [Read More…]
  • U.S. Delegation to the 63rd UN Commission on Narcotic Drugs in Vienna, Austria
    In Crime Control and Security News
    Office of the [Read More…]
  • On the Passing of Former Papua New Guinea Prime Minister Sir Michael Somare
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • Elliott Broidy Pleads Guilty for Back-Channel Lobbying Campaign to Drop 1MDB Investigation and Remove a Chinese Foreign National
    In Crime News
    Elliott Broidy, 63, of Beverly Hills, California, pleaded guilty today before U.S. District Judge Colleen Kollar-Kotelly to one count of conspiracy to violate the Foreign Agents Registration Act.
    [Read More…]
  • Utah Man and His Company Indicted for Wildlife Trafficking
    In Crime News
    A Utah man and his company were charged in an indictment today with violating the Endangered Species Act and Lacey Act for their role in illegal wildlife trafficking, announced Principal Deputy Assistant Attorney General Jonathan D. Brightbill of the Justice Department’s Environment and Natural Resources Division and U.S. Attorney John W. Huber of the District of Utah.
    [Read More…]
  • Sanctioning Russia-linked Disinformation Network for its Involvement in Attempts to Influence U.S. Election
    In Crime Control and Security News
    Michael R. Pompeo, [Read More…]
  • United States Welcomes Actions by Armenia and Azerbaijan
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • The Stability and Security of the Western Balkans
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • Valley drug trafficking organizer gets life in prison
    In Justice News
    A 40-year-old resident [Read More…]
  • Colorado Man Sentenced for Sexual Exploitation of Children in Guatemala
    In Crime News
    A Colorado man was sentenced today to 60 years in prison for production, transportation, and possession of child pornography.
    [Read More…]
  • Former NGO Procurement Official Pleads Guilty to Bribery
    In Crime News
    A former non-governmental organization (NGO) procurement official pleaded guilty today to paying bribes to NGO procurement officers in exchange for sensitive procurement information related to NGO contracts funded in part by the U.S. Agency for International Development (USAID). These contracts were for the procurement of food and supplies that would ultimately be provided to those affected by various humanitarian crises, including refugees displaced by the conflict in Syria.
    [Read More…]
  • Fake Title – Maintenance (4/18)
    In U.S GAO News
    GAO Email Notification Test We are testing our notification distribution process for GAO reports. If you are able to read this information the link contained in the email notification link worked. Please confirm that you received the email notification from GAOReports@gao.gov and used the link to access the prepublication site by contacting Andrea Thomas at thomasa@gao.gov (202) 512-3147 John Miller at millerj@gao.gov (202) 512-3672 Thank you
    [Read More…]
  • Justice Department Files Statement of Interest in Michigan Religious Schools’ Challenge to COVID-19 Closing Order
    In Crime News
    The Justice Department today filed a statement of interest in federal district court in Kalamazoo, Michigan, arguing that the Free Exercise Clause of the Constitution requires the state of Michigan to justify why it cannot provide exemptions to its school closing order for in-person instruction at religious high schools when it provides exemptions for trade and technical instruction in person, college sports teams, and other educational activities.
    [Read More…]
  • Cabo Verde Travel Advisory
    In Travel
    Reconsider travel to [Read More…]
  • Colorado Springs Agrees to Improve Stormwater Management in Settlement with the United States
    In Crime News
    The U.S. Department of Justice and the U.S. Environmental Protection Agency (EPA) today announced a settlement with the City of Colorado Springs, Colorado, to resolve violations of the Clean Water Act with respect to the City’s storm sewer system.
    [Read More…]
  • Estonian National Day
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • Justice Department Files Suit Against Dallas, Texas, Towing Company for Unlawfully Selling Servicemember-Owned Vehicles
    In Crime News
    The Justice Department today filed a lawsuit in the Northern District of Texas alleging that Dallas-based towing company United Tows LLC violated the Servicemembers Civil Relief Act (SCRA), by unlawfully auctioning off vehicles owned by SCRA-protected servicemembers. 
    [Read More…]
  • On the Presidential Elections in the Republic of Palau
    In Crime Control and Security News
    Michael R. Pompeo, [Read More…]
  • Tajikistan Travel Advisory
    In Travel
    Do not travel to [Read More…]
  • Science & Tech Spotlight: Vaccine Safety
    In U.S GAO News
    Why this Matters Safe vaccines are critical to fighting diseases, from polio to COVID-19. Research shows that the protection provided by U.S. licensed vaccines outweighs their potential risks. However, misinformation and unjustified safety concerns can cause people to delay or refuse vaccination, which may increase preventable deaths and prolong negative social and economic impacts. The Science What is it? A vaccine is generally considered safe when the benefits of protecting an individual from disease outweigh the risks from potential side effects (fig. 1). The most common side effects stem from the body's immune reaction and include swelling at the injection site, fever, and aches. Figure 1. Symptoms of polio and side effects of the polio vaccine. A vaccine is generally considered safe if its benefits (preventing disease) outweigh its risks (side effects). In rare cases, some vaccines may cause more severe side effects. For example, the vaccine for rotavirus—a childhood illness that can cause severe diarrhea, dehydration, and even death—can cause intestinal blockage in one in 100,000 recipients. However, the vaccine is still administered because this very rare side effect is outweighed by the vaccine's benefits: it saves lives and prevents an estimated 40,000 to 50,000 childhood hospitalizations in the U.S. each year. The two messenger RNA (mRNA) vaccines authorized for COVID-19—a disease that contributed to more than 415,000 American deaths between January 2020 and January 2021—can cause severe allergic reactions. However, early safety reporting found that these reactions have been extremely rare, with only about five cases per 1 million recipients, according to data from January 2021 reports by the Centers for Disease Control and Prevention. In general, side effects from vaccines are less acceptable to the public than side effects from treatments given to people who already have a disease. What is known? Vaccine developers assess safety from early research, through laboratory and animal testing, and even after the vaccine is in use (fig. 2). Researchers may rely on previous studies to inform future vaccine trials. For example, safety information from preclinical trials of mRNA flu vaccine candidates in 2017 allowed for the acceleration of mRNA COVID-19 vaccine development. Vaccine candidates shown to be safe in these preclinical trials can proceed to clinical trials in humans. In the U.S., clinical trials generally proceed through three phases of testing involving increasing numbers of volunteers: dozens in phase 1 to thousands in phase 3. Although data may be collected over years, most common side effects are identified in the first 2 months after vaccination in clinical trials. After reviewing safety and other data from vaccine studies, the Food and Drug Administration (FDA) may license a vaccine to be marketed in the U.S. There are also programs to expedite—but not bypass—development and review processes, such as a priority review designation, which shortens FDA’s goal review time from 10 to 6 months. Safety monitoring continues after licensing. For example, health officials are required to report certain adverse events—such as heart problems—following vaccination, in order to help identify potential long-term or rare side effects that were not seen in clinical trials and may or may not be associated with the vaccine. Figure 2. Vaccine safety is assessed at every stage: development through post-licensure. Following a declared emergency, FDA can also issue emergency use authorizations (EUA) to allow temporary use of unlicensed vaccines if there is evidence that known and potential benefits of the vaccine outweigh known and potential risks, among other criteria. As of January 2021, two COVID-19 vaccines had received EUAs, after their efficacy and short-term safety were assessed through large clinical trials. However, developers must continue safety monitoring and meet other requirements if they intend to apply for FDA licensure to continue distribution of these vaccines after the emergency period has ended. What are the knowledge gaps? One knowledge gap that can remain after clinical trials is whether side effects or other adverse events may occur in certain groups. For example, because clinical trials usually exclude certain populations, such as people who are pregnant or have existing medical conditions, data on potential adverse events related to specific populations may not be understood until vaccines are widely administered. In addition, it can be difficult to determine the safety of new vaccines if outbreaks end suddenly. For example, vaccine safety studies were hindered during the 2014-2015 Ebola epidemic when a large increase in the number of cases was followed by a sharp decrease. This disrupted the clinical trials of Ebola vaccine candidates, because the trials require many infected and non-infected people. Furthermore, a lack of understanding and/or misinformation about the steps taken to ensure the safety of vaccines hinders accurate public knowledge about safety concerns, which may cause people to delay or refuse vaccination. This resulting hesitancy may, in turn, increase deaths, social harm, and economic damage. Opportunities Continuing and, where necessary, improving existing vaccine safety practices offers the following opportunities to society: Herd immunity. Widespread immunity in a population, acquired in large part through safe and effective vaccines, can slow the spread of infection and protect those most vulnerable. Health care improvements. Vaccinations can reduce the burden on the health care system by reducing severe symptoms that require individuals to seek treatment. Eradication. Safe vaccination programs, such as those combatting smallpox, may eliminate diseases to the point where transmission no longer occurs. Challenges There are a number of challenges to ensuring safe vaccines: Public confidence. Vaccine hesitancy, in part due to misinformation or historic unethical human experimentation, decreases participation in clinical trials, impeding identification of side effects across individuals with different racial, ethnic, and socioeconomic backgrounds. Mutating viruses. Some viruses, such as those that cause the flu or COVID-19, may mutate rapidly and thus may require new or updated vaccines, for which ongoing safety monitoring is important. Long-term and rare effects. Exceedingly rare or long-term effects may not be identified until after vaccines have been widely administered. Further study is needed to detect any such effects and confirm they are truly associated with the vaccine. Policy Context & Questions What steps can policymakers take to improve public trust and understanding of the process of assessing vaccine safety? How can policymakers convey the social importance of vaccines to protect the general public and those who are most vulnerable? How can policymakers leverage available resources to support ongoing vaccine development and post-licensure safety monitoring? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov.
    [Read More…]
  • Justice Department Settles Sex Discrimination Lawsuit Alleging Disparate Treatment Against Female Correctional Officers by the Michigan Department of Corrections
    In Crime News
    The Justice Department today announced that it has reached a settlement, through a court-supervised settlement agreement, with the State of Michigan and the Michigan Department of Corrections (MDOC) to resolve a sex discrimination lawsuit brought by the United States of America.
    [Read More…]
  • U.S. Government Accountability Office (U.S. GAO)
    In U.S GAO News
    What GAO Found The Navy has identified several challenges with using its regular maintenance capability (which restores ships to fully operational status) to provide battle damage repairs during a great power conflict. Challenges include—the lack of established doctrine for battle damage repair, unclear command and control roles, and a shortage of repair capacity. The Navy Process for Repairing Ships Damaged in Battle The Navy is in the early stages of determining how it will provide battle damage repair during a great power conflict. Eight organizations are responsible for the Navy's 15 battle damage repair planning efforts, however the Navy has not designated an organization to lead and oversee these efforts. Without designated leadership, the Navy may be hindered in its efforts to address the many challenges it faces in sustaining its ships during a great power conflict. The Navy develops ship vulnerability models during a ship's acquisition to estimate damage during a conflict. These models are also used to inform war games that refine operational approaches and train leaders on decision-making. However, the Navy does not update these models over a ship's decades-long service life to reflect changes to key systems that could affect model accuracy. As a result, it lacks quality data on ship mission-critical failure points to inform its analysis of battle damage repair needs. Without periodically assessing and updating its models to accurately reflect the ship's mission-critical systems, the Navy has limited its ability to assess and develop battle damage repair capabilities necessary to sustain ships in a conflict with a great power competitor. Why GAO Did This Study The ability to repair and maintain ships plays a critical role in sustaining Navy readiness. After the Cold War, the Navy divested many wartime ship repair capabilities. With the rise of great power competitors capable of producing high-end threats in warfare, the Navy must now be prepared to quickly salvage and repair damage to a modern fleet. House Report 116-120, accompanying a bill for the National Defense Authorization Act for Fiscal Year 2020, included a provision for GAO to assess the Navy's efforts to identify and mitigate challenges in repairing battle-damaged ships during a great power conflict. GAO's report (1) discusses the challenges the Navy has identified in using its regular maintenance capability for battle damage repair, and (2) evaluates the extent to which the Navy has begun developing the battle damage repair capability it requires to prevail in a great power conflict. GAO reviewed relevant guidance and assessed reports on naval war games and other documentation to identify challenges that may impede the planning and repair of battle-damaged ships and efforts to improve the repair capability for a great power conflict.
    [Read More…]
  • Attorney General Barr Chairs Meeting of the Federal Interagency Council on Crime Prevention and Improving Reentry
    In Crime News
    Attorney General William [Read More…]
  • Sanctions Against Businesses Linked to Mexican Cartels
    In Crime Control and Security News
    Michael R. Pompeo, [Read More…]
  • Attorney General Merrick B. Garland Announces New Effort to Reduce Violent Crime
    In Crime News
    Attorney General Merrick B. Garland today announced a new Department of Justice effort to help protect our communities from the recent increase in major violent crimes.
    [Read More…]
  • Two Men Charged in Ecuadorian Bribery and Money Laundering Scheme
    In Crime News
    Criminal complaints have been unsealed charging two Ecuadorian citizens for their alleged roles in a bribery and money laundering scheme involving Ecuador’s public police pension fund (ISSPOL).
    [Read More…]
  • Armenia Travel Advisory
    In Travel
    Reconsider travel to [Read More…]
  • Statement by Attorney General William P. Barr on Mexico’s Proposed Legislation
    In Crime News
    Attorney General William P. Barr gave the following statement in response to Mexico's proposed legislation:
    [Read More…]
  • Department of Justice Begins Second Distribution of Funds Recovered Through Asset Forfeiture to Compensate Victims of Western Union Fraud Scheme, Bringing Total to Over $300 Million
    In Crime News
    The Department of Justice announced today that the Western Union Remission Fund began its second distribution of approximately $148 million in funds forfeited to the U.S. government from the Western Union Company (Western Union) to approximately 33,000 victims located in the United States and abroad. These victims, many of whom were elderly victims of consumer fraud and abuse, will be recovering the full amount of their losses.
    [Read More…]
  • On the 41st Anniversary of the U.S. Embassy Takeover in Tehran
    In Crime Control and Security News
    Michael R. Pompeo, [Read More…]
  • Venezuela: Additional Tracking Could Aid Treasury’s Efforts to Mitigate Any Adverse Impacts U.S. Sanctions Might Have on Humanitarian Assistance
    In U.S GAO News
    The Venezuelan economy's performance has declined steadily for almost a decade and fallen steeply since the imposition of a series of U.S. sanctions starting in 2015. For example, the economy declined from negative 6.2 percent gross domestic product growth in 2015 to negative 35 percent in 2019 and negative 25 percent in 2020. The sanctions, particularly on the state oil company in 2019, likely contributed to the steeper decline of the Venezuelan economy, primarily by limiting revenue from oil production. However, mismanagement of Venezuela's state oil company and decreasing oil prices are among other factors that have also affected the economy's performance during this period. U.S. agencies have sought input from humanitarian organizations to identify the potential negative humanitarian consequences of sanctions related to Venezuela and taken steps to mitigate these issues. The U.S. Agency for International Development (USAID) and Department of State (State) have solicited input from U.S.-funded humanitarian organizations on challenges they face, including the impact of sanctions. The U.S. Department of the Treasury (Treasury) and State have also taken steps to mitigate negative consequences. For example, Treasury issued licenses permitting various types of humanitarian assistance transactions in Venezuela (see figure). Treasury also maintains a call center and email account through which organizations can receive assistance with compliance issues or other challenges related to sanctions. While Treasury officials told GAO they respond to individual inquiries, Treasury does not systematically track and analyze information from these inquiries to identify trends or recurrent issues. Without collection and analysis of this information, Treasury and its interagency partners may be limited in their ability to develop further actions to ensure that U.S. sanctions do not disrupt humanitarian assistance. U.S. Humanitarian Assistance Supplies for Venezuelans U.S. sanctions related to Venezuela have likely had a limited impact, if any, on the U.S. oil industry. Despite an overall lower supply of oil in the U.S. market from the loss of Venezuelan crude oil due to sanctions, crude oil and retail gasoline prices in the U.S. have not increased substantially. Many other factors in addition to the sanctions simultaneously affected the oil market and the price of crude oil and retail gasoline prices, including production cuts in January 2019 by the Organization of the Petroleum Exporting Countries and decreased demand for energy during the COVID-19 pandemic. According to industry officials to whom GAO spoke, U.S. refineries have adjusted to these changes by shifting to alternative sources and types of crude oil. Venezuela has been experiencing an economic, political, and humanitarian crisis. The U.S. government has imposed sanctions on Venezuela's state oil company, government, and central bank, among others, in response to activities of the Venezuelan government and certain individuals. Treasury and the Department of State lead the implementation of the sanctions program, and USAID is primarily responsible for implementing humanitarian assistance for Venezuelans. GAO was asked to review U.S. sanctions related to Venezuela. This report examines: (1) how the Venezuelan economy performed before and since the imposition of sanctions in 2015; (2) the steps U.S. agencies have taken to identify and mitigate potential negative humanitarian consequences of sanctions related to Venezuela; and (3) what is known about the impact of U.S. sanctions related to Venezuela on the U.S. oil industry. GAO analyzed economic indicators, reviewed documents, interviewed agency officials, and spoke with representatives from selected humanitarian organizations and the U.S oil industry. GAO recommends that Treasury systematically track inquiries made to its call center and email account, including the specific sanctions program and the subject matter of the inquiry to identify trends and recurring issues. Treasury concurred with GAO's recommendation. For more information, contact Kimberly Gianopoulos at (202) 512-8612 or GianopoulosK@gao.gov.
    [Read More…]
  • Public Designation of Oligarch and Former Ukrainian Public Official Ihor Kolomoyskyy Due to Involvement in Significant Corruption
    In Crime Control and Security News
    Antony J. Blinken, [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…]
  • Operation Legend Expanded to Memphis and St. Louis
    In Crime News
    Today, the expansion of [Read More…]
  • Burundi Travel Advisory
    In Travel
    Do not travel to Burundi [Read More…]
  • Secretary Blinken’s Call with Australian Foreign Minister Payne
    In Crime Control and Security News
    Office of the [Read More…]
  • LymeX: Applying Health+ for Patient-Powered Innovations
    In Human Health, Resources and Services
    April 12, 2021 By: Alex [Read More…]
  • Dow Chemical Company and Two Subsidiaries will Reduce Harmful Air Pollution at Four U.S. Chemical Plants
    In Crime News
    The Department of Justice, the U.S. Environmental Protection Agency (EPA), and the Louisiana Department of Environmental Quality (LDEQ) announced a settlement with Dow Chemical Company and two subsidiaries, Performance Materials NA Inc. and Union Carbide Corporation, that will eliminate thousands of tons of air pollution from four of Dow’s petrochemical manufacturing facilities in Texas and Louisiana.
    [Read More…]
  • Department Press Briefing – February 3, 2021
    In Crime Control and Security News
    Ned Price, Department [Read More…]