Pharr man pleads guilty to smuggling multiple drugs in cardboard box

A 46-year-old Pharr man has entered a guilty plea to conspiracy to possess with intent to distribute 1.42 kilograms of meth

Read full article at: https://www.justice.gov May 4, 2021

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    In U.S GAO News
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    The 340B Drug Pricing Program (340B Program) requires drug manufacturers to sell outpatient drugs at a discount to covered entities—eligible hospitals and other entities participating in the program—in order for their drugs to be covered by Medicaid. Participation in the 340B Program has grown from nearly 9,700 covered entities in 2010 to 12,700 in 2020. The Department of Health and Human Services' (HHS) Health Resources and Services Administration (HRSA) administers the program and oversees covered entities' compliance with 340B Program requirements through annual audits, among other efforts. If audits identify noncompliance with program requirements, HRSA issues findings to covered entities and requires them to take corrective action to continue participating in the 340B Program (see table). Audit Findings Issued to Covered Entities by the Health Resources and Services Administration (HRSA) for Fiscal Years 2012-2019, as of September 2020 340B Program findings of noncompliance Number Eligibility of covered entities. Failure to maintain eligibility-related requirements (e.g., covered entities' oversight of their contract pharmacies). 561 Diversion of 340B drugs to ineligible patients. 340B drugs distributed to individuals who are not eligible patients of a covered entity (e.g., patients' health records are not maintained by the covered entity). 546 Duplicate discounts. Prescribed drugs that may have been subject to both the 340B price and a Medicaid rebate. 429 Total 1,536 Source: GAO analysis of information received from HRSA. | GAO-21-107 HRSA officials told GAO that, beginning in fall 2019, the agency started issuing findings only when audit information presents a clear and direct violation of the requirements outlined in the 340B Program statute. HRSA officials explained that guidance, which is used to interpret provisions of the 340B statute for the purposes of promoting program compliance among covered entities, does not provide the agency with appropriate enforcement capability. For example, HRSA officials reported that there were instances among fiscal year 2019 audits in which the agency did not issue findings for a failure to comply with guidance related to contract pharmacies in part because the 340B statute does not address contract pharmacy use and, therefore, there may not have been a clear statutory violation. In addition to audits, HRSA provides education to covered entities about 340B Program requirements and has implemented other efforts to identify noncompliance. For example, HRSA requires all covered entities to recertify their eligibility to participate in the 340B Program annually (e.g., self-attesting to compliance); and uses a self-disclosure process through which covered entities can disclose and correct self-identified instances of noncompliance. Covered entities can realize substantial savings through 340B Program price discounts, enabling them to stretch federal resources to reach more eligible patients and provide more comprehensive services. GAO was asked to provide information on HRSA's efforts to oversee covered entities' compliance with 340B Program requirements. This report describes (1) the audit findings that HRSA issued to address covered entity noncompliance with 340B Program requirements; and (2) other efforts HRSA uses to help ensure that covered entities comply with 340B Program requirements. GAO reviewed documentation, including relevant federal laws and regulations and HRSA's policies, procedures, and guidance, related to 340B Program oversight. GAO also reviewed HRSA data on the number and type of audit findings made from audits finalized during fiscal years 2012 through 2019 as of September 2020—the latest data available at the time of the audit. GAO also interviewed officials from HRSA, agency contractors, and 340B Program stakeholders. GAO provided a draft of this report to HHS for review. The agency provided written and technical comments on the draft, both of which were incorporated as appropriate. For more information, contact Debra A. Draper at (202) 512-7114 or draperd@gao.gov.
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    The Securities and Exchange Commission (SEC) disclosure rule broadly requires that certain companies submit a filing that describes their efforts to conduct a reasonable country-of-origin inquiry (RCOI), and depending on the preliminary determination, perform due diligence to determine the source and chain of custody of their conflict minerals—gold and specific ores for tantalum, tin, and tungsten. After conducting RCOI, an estimated 50 percent of companies filing in 2019 reported preliminary determinations as to whether the conflict minerals came from the Democratic Republic of the Congo (DRC) or adjoining countries (covered countries) or from scrap or recycled sources. The percentage of companies able to make such preliminary determinations increased significantly between 2014 and 2015, and has since leveled off, as shown below. Source of Conflict Minerals in Products as Determined by Companies' Reasonable Country-of-Origin Inquiries, Reporting Years 2014-2019 However, fewer companies reported such determinations after conducting due diligence. In 2019, an estimated 85 percent of companies made preliminary determinations that required them to then perform due diligence. Of those companies, an estimated 17 percent determined that the minerals came from covered countries—a significantly lower percentage of companies making that determination than the 37 percent reported in 2017 or the 35 percent in 2018. Since 2014, companies have noted various challenges they face in making such determinations; however, SEC staff told GAO that they did not know what factors contributed to the decrease in 2019. We will examine this issue during our future review. While the Department of State (State) and U.S. Agency for International Development (USAID) have implemented the U.S. conflict minerals strategy since 2011, they have not established performance indicators for all of the strategic objectives. For example, they have no such indicators for the objectives of strengthening regional and international efforts and promoting due diligence and responsible trade through public outreach. Without performance indicators, the agencies cannot comprehensively assess their progress toward achieving these objectives or the overall goal of addressing armed groups' exploitation of conflict minerals. Armed groups in eastern DRC continue to commit severe human rights abuses and to profit from the exploitation of “conflict minerals,” according to State. Provisions in the 2010 Dodd-Frank Wall Street Reform and Consumer Protection Act required, among other things, that State, USAID, and the SEC take certain actions to promote peace and security. In 2011, State created the U.S. conflict minerals strategy in consultation with USAID to address armed groups' exploitation of conflict minerals. In 2012, the SEC also promulgated regulations containing disclosure and reporting requirements for companies that use conflict minerals from covered countries. The act also included a provision for GAO to annually assess, among other things, the SEC regulations' effectiveness in promoting peace and security. In this report, GAO examines, among other things, how companies responded to the SEC conflict minerals disclosure rule when filing in 2019 and the extent to which State and USAID assessed progress toward the U.S. conflict minerals strategy's objectives and goal. GAO analyzed a generalizable sample of SEC filings, reviewed documents, and interviewed U.S. officials State, in consultation with USAID, should develop performance indicators for assessing progress toward the strategic objectives and goal of the U.S. conflict minerals strategy. State and USAID concurred with GAO's recommendation. For more information, contact Kimberly M. Gianopoulos at (202) 512-8612 or gianopoulosk@gao.gov.
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  • Federal Research: Agencies Need to Enhance Policies to Address Foreign Influence
    In U.S GAO News
    U.S. research may be subject to undue foreign influence in cases where a researcher has a foreign conflict of interest (COI). Federal grant-making agencies can address this threat by implementing COI policies and requiring the disclosure of information that may indicate potential conflicts. GAO reviewed five agencies—which together accounted for almost 90 percent of all federal research and development expenditures at universities in fiscal year 2018—and found that three have agency-wide COI policies, while two do not (see figure). The three agencies with existing policies focus on financial interests but do not specifically address or define non-financial interests, such as multiple professional appointments. In the absence of agency-wide COI policies and definitions on non-financial interests, researchers may not fully understand what they need to report on their grant proposals, leaving agencies with incomplete information to assess the risk of foreign influence. GAO found that, regardless of whether an agency has a conflict of interest policy, all five agencies require researchers to disclose information—such as foreign support for their research—as part of the grant proposal that could be used to determine if certain conflicts exist. Elements of Conflict of Interest (COI) Policies at Agencies with the Most Federal Research Expenditures at Universities Based on a review of university documents, GAO found that all 11 of the universities in its sample have publicly available financial and non-financial COI policies for federally funded research. These policies often align with the financial COI policies or requirements of the grant-making agencies. All five agencies have mechanisms to monitor and enforce their policies and disclosure requirements when there is an alleged failure to disclose required information. All agencies rely on universities to monitor financial COI, and most agencies collect non-financial information such as foreign collaborations, that can help determine if conflicts exist. Agencies have also taken actions in cases where they identified researchers who failed to disclose financial or non-financial information. However, three agencies lack written procedures for handling allegations of failure to disclose required information. Written procedures for addressing alleged failure to disclose required information help agencies manage these allegations and consistently apply enforcement actions. In interviews, stakeholders identified opportunities to improve responses to foreign threats to research, such as harmonizing grant application requirements. Agencies have begun to address such issues. The federal government reportedly expended about $42 billion on science and engineering research at universities in fiscal year 2018. Safeguarding the U.S. research enterprise from threats of foreign influence is of critical importance. Recent reports by GAO and others have noted challenges faced by the research community to combat undue foreign influence, while maintaining an open research environment that fosters collaboration, transparency, and the free exchange of ideas. GAO was asked to review federal agency and university COI policies and disclosure requirements. In this report, GAO examines (1) COI policies and disclosure requirements at selected agencies and universities that address potential foreign threats, (2) mechanisms to monitor and enforce policies and requirements, and (3) the views of selected stakeholders on how to better address foreign threats to federally funded research. GAO reviewed laws, regulations, federal guidance, and agency and university COI policies and requirements. GAO also interviewed agency officials, university officials, and researchers. GAO is making nine recommendations to six agencies, including that grant-making agencies address non-financial conflicts of interest in their COI policies and develop written procedures for addressing cases of failure to disclose required information. Five agencies agreed with GAO's recommendations. The National Science Foundation neither agreed nor disagreed with GAO's recommendation, but identified actions it plans to take in response. For more information, contact Candice N. Wright at (202) 512-6888 or wrightc@gao.gov.
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  • Facial Recognition Technology: Privacy and Accuracy Issues Related to Commercial Uses
    In U.S GAO News
    Market research and other data suggest that the market for facial recognition technology has increased in the number and types of businesses that use it since GAO's 2015 report on the topic (GAO-15-621 ). For example, newer functions of the technology identified by stakeholders and literature included authorizing payments and tracking and monitoring attendance of students, employees, or those attending events. Functions of Facial Recognition Technology Accuracy. Although the accuracy of facial recognition technology has increased dramatically in recent years, differences in performance exist for certain demographic groups. National Institute of Standards and Technology tests found that facial recognition technology generally performs better on lighter-skin men and worse on darker-skin women, and does not perform as well on children and elderly adults. These differences could result in more frequent misidentification for certain demographics, such as misidentifying a shopper as a shoplifter when comparing the individual's image against a data set of known shoplifters. There is no consensus on what causes performance differences, including physical factors (such as lighting) or factors related to the creation or operation of the technology. However, stakeholders and literature identified various methods that could help mitigate differences in performance among demographic groups. Privacy. Stakeholders and literature identified concerns related to privacy, such as the inability of individuals to remain anonymous in public or the use of the technology without individuals' consent. Facial recognition technology may collect or store facial images, posing varying levels of risk. Some federal and state laws and the European Union's General Data Protection Regulation impose requirements on U.S. companies related to facial recognition technology. However, as we reported in 2015, there is no comprehensive federal privacy law governing the collection, use, and sale of personal information by private-sector companies. Some stakeholders, including privacy and industry groups, have developed voluntary frameworks that seek to address privacy concerns. Most of these frameworks were consistent with internationally recognized principles for protecting the privacy and security of personal information. However, U.S. companies are not required to follow these voluntary frameworks. Facial recognition technology can verify or identify an individual from a facial image. Advocacy groups and others have raised privacy concerns related to private companies' use of the technology, as well as concerns that higher error rates among some demographic groups could lead to disparate treatment. GAO was asked to review the commercial use of facial recognition technology and related accuracy and privacy issues. Among other issues, this report examines how companies use the technology, its accuracy and how accuracy differs across demographic groups, and how privacy issues are addressed in laws and industry practices. GAO analyzed laws; reviewed literature and company documentation; interviewed federal agency officials; and interviewed representatives from companies, industry groups, and privacy groups. GAO also reviewed selected privacy frameworks, chosen based on expert recommendations and research. GAO reiterates its previous suggestion from a 2013 report ( GAO-13-663 ) that Congress consider strengthening the consumer privacy framework to reflect changes in technology and the marketplace. For more information, contact Alicia Puente Cackley at (202) 512-8678 or cackleya@gao.gov.
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  • Over-The-Counter Drugs: Information on FDA’s Regulation of Most OTC Drugs
    In U.S GAO News
    The Food and Drug Administration (FDA) has regulated most over-the-counter (OTC) drugs—that is, drugs available without a prescription—through the OTC monograph process. FDA has described an OTC monograph as a "rulebook" for marketing safe and effective OTC drugs, such as aspirin, cough and cold medicine, and hand sanitizer. OTC monographs established conditions—such as active ingredients, indications for use, dosage forms, and product labeling—under which an OTC drug was generally recognized as safe and effective. According to FDA officials, before the CARES Act, which was enacted in March 2020, the agency's ability to update and finalize monographs in response to safety issues and to reflect new scientific information was limited by the rulemaking process the agency was required to follow, as well as insufficient resources. Agency officials estimated that it took at least 6 years to complete the required rulemaking process. Additionally, the agency reported it was critically under-resourced to regulate the estimated 100,000 OTC drugs marketed through the monograph process. However, the CARES Act provided for a new process to regulate these OTC drugs rather than the rulemaking process. FDA officials expect it will take less time to update and finalize requirements for OTC drugs using the new process. The CARES Act also authorized FDA to assess user fees to provide additional resources to regulate OTC drugs. Although FDA officials said this new process and user fees should improve its regulation of OTC drugs, the agency's analysis of the effect of the CARES Act is still ongoing. FDA officials told GAO that prior to the CARES Act, they used various methods to identify and respond to safety issues related to OTC drugs. For example, to identify these issues, FDA officials said they read medical literature related to safety issues and reviewed reports submitted to the agency's adverse event reporting system. To respond to these issues, FDA took steps such as issuing drug safety communications to consumers and requesting that manufacturers make changes to a drug's labeling. For example, in 2015, two FDA advisory committees recommended that cough and cold drugs with codeine be removed from the relevant OTC monograph for use in drugs in children. In 2018, FDA also issued a drug safety communication stating the risks outweighed the benefits for the use of these drugs in children. However, FDA officials said these methods were not a substitute for rulemaking because manufacturers could legally market their OTC drugs without making requested safety changes until the rulemaking process was completed. According to FDA officials, the new process for regulating OTC drugs included in the CARES Act could improve FDA's ability to address identified safety risks in a more timely and efficient manner in the future. The act established an expedited process to address safety issues that pose an imminent hazard to public health or to change a drug's labeling to mitigate a significant or unreasonable risk of a serious adverse event. OTC drugs prevent and treat a variety of conditions; for example, sunscreen is used to help prevent sunburn. FDA officials and stakeholders, such as industry representatives and patient and provider groups, have questioned whether the monograph process used to regulate most OTC drugs has been overly burdensome and has limited FDA's ability to quickly update and finalize monographs in response to potential safety issues for consumers. Enacted in March 2020, the CARES Act changed how FDA regulates OTC drugs. The Sunscreen Innovation Act included a provision for GAO to review FDA's regulation of OTC drugs. This report describes, among other issues, (1) the factors that affected FDA's ability to regulate OTC drugs and (2) how FDA identified and responded to safety issues associated with these drugs. GAO reviewed federal statutes and agency documents and interviewed FDA officials and stakeholders familiar with the monograph process. These stakeholders included representatives from the OTC drug industry, health care provider and consumer groups, and researchers. The Department of Health and Human Services provided technical comments on this report, which GAO incorporated as appropriate. For more information, contact John E. Dicken at (202) 512-7114 or dickenj@gao.gov.
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    In Crime News
    Six individuals were charged in an indictment with fraudulently obtaining approximately $1.5 million in Paycheck Protection Program (PPP) loans on behalf of five businesses based in Georgia and South Carolina.
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    In Crime Control and Security News
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  • Two Alleged Hackers Charged with Defacing Websites Following Killing of Qasem Soleimani
    In Crime News
    Two alleged computer hackers were indicted in the District of Massachusetts on charges of damaging multiple websites across the United States as retaliation for United States military action in January 2020 that killed Qasem Soleimani, the head of the Islamic Revolutionary Guard Corps-Quds Force, a U.S.-designated foreign terrorist organization.
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    In Crime Control and Security News
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    In Crime News
    The Justice Department today announced that it reached an agreement with Spencer East Brookfield Regional School District in Spencer, Massachusetts to resolve the department’s lawsuit alleging disability discrimination in violation of the Americans with Disabilities Act (ADA).
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  • Judiciary Addresses Cybersecurity Breach: Extra Safeguards to Protect Sensitive Court Records
    In U.S Courts
    After the recent disclosure of widespread cybersecurity breaches of both private sector and government computer systems, federal courts are immediately adding new security procedures to protect highly sensitive confidential documents filed with the courts.
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    In Crime Control and Security News
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  • The Nation’s Fiscal Health: Information on the Spending and Revenue Implications of Potential Debt Targets
    In U.S GAO News
    The COVID-19 pandemic has necessitated major federal spending to respond to the national public health emergency and resulting economic turmoil. This response and the severe economic contraction from the pandemic have led to increased federal debt. Once the COVID-19 pandemic abates and the economy has substantially recovered, Congress and the administration will need to address the federal government’s fiscal challenges. To help change the long-term fiscal path, in September 2020 GAO recommended that Congress consider establishing a long-term fiscal plan that includes fiscal rules and targets, such as a debt-to-gross domestic product (GDP) target. In this report, GAO analyzed the changes in spending and revenue needed to reach six potential debt-to-GDP targets at the end of a 30-year period (2020-2049). To reach any of the targets, policymakers will need to cut program spending, increase revenue, or, most likely, a combination of both (see table). Illustrative Examples of Changes Needed to Achieve Debt-to-GDP Targets Debt target, percent of GDP (end of 30 years) Spending and revenue: total change over 30 years Program spending alone: Immediate and permanent decrease needed in annual projected program spendinga Revenue alone: Immediate and permanent increase needed in annual projected revenue Percent Dollars, trillions Percent Percent 140 25.4 13.8 18.5 120 31.2 16.9 22.8 100 37 20 27 80 42.8 23.1 31.2 60 48.5 26.3 35.4 0 (paying off all debt) 65.9 35.7 48.1 Source: GAO simulation. | GAO-21-211. Note: The simulation used for this analysis generally reflect historical trends, such as the extension of tax provisions scheduled to expire. It does not account for potential macroeconomic effects of fiscal policy changes over time. aProgram spending consists of all spending except interest payments on debt held by the public. When considering the spending and revenue changes needed to achieve various debt-to-GDP targets, policymakers may also consider how changes in assumptions about key variables—such as discretionary spending, revenue, and GDP—affect these fiscal outcomes. For example, if GDP growth is greater than expected, policymakers may have to make smaller spending cuts or revenue increases to reach a selected debt-to-GDP target than those that would be needed based on GAO’s standard assumptions. GAO created an interactive web tool accompanying this report to allow users to enter different assumptions for each of these variables. This tool illustrates how these changes would affect the different debt-to-GDP targets over time, as well as the changes in spending and revenue needed to achieve various targets. This tool can be found at https://www.gao.gov/products/GAO-21-211. Even before the fiscal and economic effects resulting from COVID-19, an imbalance between federal revenue and spending that is built into current law and policy was contributing to the growing federal debt. The Congressional Budget Office projects that by 2023 federal debt held by the public will reach 107 percent of GDP, its highest point in U.S. history. This situation—in which federal debt grows faster than GDP—means that our nation is on an unsustainable fiscal path. GAO was asked to review issues related to fiscal rules and targets and the federal fiscal condition. In response to this request, in September 2020, GAO issued a report (GAO-20-561) on key considerations for the design, implementation, and enforcement of fiscal rules and targets. This report supplements that work and describes how changes in assumptions of future spending and revenue affect the federal government’s projected fiscal condition. GAO updated its long-term simulations of federal revenue and spending to (1) analyze six potential debt-to-GDP targets and (2) measure the fiscal gap—the policy change needed to reach a given debt-to-GDP fiscal target from the start to the end of 30-years. GAO also analyzed how changes in key variables affected the debt-to-GDP targets and the fiscal gap. For more information, contact Jeff Arkin at (202) 512-6806 or arkinj@gao.gov.
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