District Court Orders Washington State Company and its Owner to Stop Distributing Adulterated Juice Products

A federal court permanently enjoined a Sunnyside, Washington, company from preparing, processing, and distributing adulterated juice and other food products, the Department of Justice announced today.

More from: January 15, 2021

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    In U.S GAO News
    The Department of Veterans Affairs' (VA) Veterans Health Administration (VHA) provides veterans with prosthetic services to assist with their mobility, vision, and hearing needs. The proportion of prosthetics VHA provided to female veterans has been small compared to the share provided to male veterans. However, in fiscal years 2015 to 2019, this proportion grew from 6.8 percent to 7.9 percent and accounted for about $889.1 million of the $15.4 billion total cost of prosthetics. Artificial limbs comprised a relatively small number of the total prosthetics VHA provided to veterans in fiscal years 2015 to 2019; however, veterans who use artificial limbs have complex needs and are significant users of health care services. VHA provided prosthetic services to a small but growing female veteran amputee population (almost 3 percent of veteran amputees in fiscal year 2019), who were generally younger than male veteran amputees. VHA has established an individualized patient care approach in its Amputation System of Care that seeks to address the prosthetic needs of each veteran, including accounting for gender-specific factors. VHA officials said that using a standardized, multidisciplinary approach across VA medical facilities also helps them incorporate the concerns and preferences of female veterans. For example, veterans are provided care by a team that includes a physician, therapist, prosthetist (clinician who helps evaluate prosthetic needs and then designs, fabricates, fits, and adjusts artificial limbs), and other providers as needed. Female veteran amputees GAO spoke with at one VA medical facility said they were satisfied with their VHA care. They also noted a lack of commercially available prosthetic options that VHA providers can use to meet women's needs. Examples of Female Veterans' Artificial Limb Prosthetics Women are generally studied less than their male counterparts in prosthetic and amputee rehabilitation research. VHA designated prosthetics for female veterans a national research priority in 2017, and has funded eight related studies as of May 2020: four pertain to lower limb amputation, three pertain to upper limb amputation, and one pertains to wheelchairs. VHA officials noted the importance of this research priority and the ongoing challenge of recruiting study participants due to the small female veteran population. VHA researchers said they employ various tactics to address this challenge, such as using multi-site studies and recruiting participants from the non-veteran population. Women are the fastest growing veteran subpopulation, with the number of female veterans using VHA health care services increasing 29 percent from 2014 to 2019. Female veterans accounted for an estimated 10 percent of the total veteran population in fiscal year 2019. They are eligible to receive a full range of VHA health care services, including obtaining prosthetics. House Report 115-188 included a provision for GAO to review VHA's prosthetic services for female veterans. This report examines 1) trends in prosthetics provided by VHA to female veterans; 2) characteristics of the female veteran population with limb loss and how VHA provides prosthetic services to these veterans through its Amputation System of Care; and 3) VHA's research efforts and the challenges that exist in studying prosthetics for female veterans with limb loss. GAO analyzed VHA documents, as well as data from fiscal years 2015 to 2019 on prosthetics and veterans with amputations. GAO interviewed agency officials from VHA central office and officials and female veteran amputees at two VA medical facilities selected for expertise in amputation care and prosthetics research activities. In addition, GAO interviewed VHA researchers conducting studies on prosthetics for female veterans. GAO provided a draft of this report to VA. VA provided general and technical comments, which were incorporated as appropriate. For more information, contact Jessica Farb at (202) 512-7114 or farbj@gao.gov.
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    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.
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    In U.S GAO News
    The Office of Refugee Resettlement's (ORR) grant announcements soliciting care providers for unaccompanied children—those without lawful immigration status and without a parent or guardian in the U.S. available to provide care and physical custody for them—lack clarity about what state licensing information is required. Further, ORR does not systematically confirm the information submitted by applicants or document a review of their past performance on ORR grants, when applicable, according to GAO's analysis of ORR documents and interviews with ORR officials. The grant announcements do not specify how applicants without a state license should show license eligibility—a criterion for receiving an ORR grant—or specify what past licensing allegations and concerns they must report. In addition, the extent to which ORR staff verify applicants' licensing information is unclear. In fiscal years 2018 and 2019, ORR awarded grants to approximately 14 facilities that were unable to serve children for 12 or more months because they remained unlicensed. In addition, ORR did not provide any documentation that staff conducted a review of past performance for the nearly 70 percent of applicants that previously held ORR grants. Without addressing these issues, ORR risks awarding grants to organizations that cannot obtain a state license or that have a history of poor performance. State licensing agencies regularly monitor ORR-funded facilities, but according to GAO's survey of these agencies, their information sharing with ORR is limited (see figure). State licensing agencies and ORR staff both said that improved information sharing would benefit their monitoring of facilities. Without such improvements, ORR may lack information about ongoing issues at its facilities. Key Survey Responses on Information-Sharing with the Office of Refugee Resettlement (ORR) by the 23 State Agencies That Licensed ORR-Funded Facilities in Fall 2019 ORR requires grantees to take corrective action to address noncompliance it identifies through monitoring, but ORR has not met some of its monitoring goals or notified grantees of the need for corrective actions in a timely manner. For example, under ORR regulations, each facility is to be audited for compliance with standards to prevent and respond to sexual abuse and harassment of children by February 22, 2019, but by April 2020, only 67 of 133 facilities had been audited. In fiscal years 2018 and 2019, ORR also did not meet its policy goals to visit each facility at least every 2 years, or to submit a report to facilities on any corrective actions identified within 30 days of a visit. Without further action, ORR will continue to not meet its own monitoring goals, which are designed to ensure the safety and well-being of children in its care. ORR is responsible for the care and placement of unaccompanied children in its custody, which it provides through grants to state-licensed care provider facilities. ORR was appropriated $1.3 billion for this program in fiscal year 2020. GAO was asked to review ORR's grant making process and oversight of its grantees. This report examines (1) how ORR considers state licensing issues and past performance in its review of grant applications; (2) state licensing agencies' oversight of ORR grantees, and how ORR and states share information; and (3) how ORR addresses grantee noncompliance. GAO reviewed ORR grant announcements and applications for fiscal years 2018 and 2019. GAO conducted a survey of 29 state licensing agencies in states with ORR facilities, and reviewed ORR monitoring documentation and corrective action reports. GAO also reviewed ORR guidance and policies, as well as relevant federal laws and regulations, and interviewed ORR officials. GAO is making eight recommendations to ORR on improving clarity in its grant announcements, communication with state licensing agencies, and monitoring of its grantees. ORR agreed with all eight recommendations. For more information, contact Kathryn A. Larin at (202) 512-7215 or larink@gao.gov.
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