Federal Court Shuts Down Atlanta Area Tax Return Preparer

The Justice Department announced today that a federal court in the Northern District of Georgia permanently enjoined the owner of tax preparation businesses in Suwanee, Georgia, from preparing federal tax returns for others.

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    Research conducted at Department of Health and Human Services (HHS) labs led to 4,446 U.S. patents owned by the agency covering a range of inventions from 1980 through 2019. During that period, the National Institutes of Health (NIH) had 93 patents—2 percent of the total—that contributed to the successful development of 34 drugs approved by the Food and Drug Administration (FDA) and brought to market, including vaccines and treatments for cancer. These 34 drugs were developed by pharmaceutical companies and were associated with 32 licenses granted to them by NIH. As shown in the figure, these licenses have generated up to $2 billion in royalty revenue for NIH since 1991, when FDA approved the first of these drugs. Three licenses generated more than $100 million each for the agency. Royalties from NIH Licenses of Inventions Associated with FDA-Approved Drugs, 1991 to February 2020 When licensing its inventions, NIH prioritizes the likelihood that the licensee can successfully develop a drug by considering such factors as technical expertise and the ability to raise capital. Consistent with federal interpretation of technology transfer statutory authorities, NIH does not consider the affordability of the resulting drug. NIH provides limited information to the public about its licensing activities. For example, the agency does not report which of its patents are licensed or release metrics that would enable the public to evaluate how licensing affects patient access to resulting drugs. Increasing the transparency of its licensing activities could improve the public’s and policymakers’ understanding of NIH’s management of its intellectual property. HHS monitors for unauthorized use of its inventions (infringement) and has taken steps to protect its rights. HHS relies primarily on inventors at its labs to monitor for potential infringement and generally encourages potential infringers to license the inventions. If cases proceed to litigation, HHS relies on the Department of Justice (DOJ) to protect its rights. Since 2009, HHS has worked with DOJ to defend its intellectual property in several cases in the U.S. and abroad and has referred one case to DOJ for litigation against an alleged infringer. HHS labs conduct research that can contribute to the development of new life-saving drugs. HHS may grant rights to its inventions by licensing the patents to pharmaceutical companies that conduct the additional development activities and testing necessary to bring drugs to market. Public health experts and patients’ rights advocates have raised concerns about the prices of drugs developed with federal support. GAO was asked to review HHS’s management of its intellectual property. This report examines (1) the extent to which HHS-owned intellectual property has contributed to the development of FDA-approved drugs, (2) what is known about the licenses associated with FDA-approved drugs, (3) factors NIH prioritizes when licensing its inventions and information about licensing it makes public, and (4) steps HHS has taken to protect its rights. GAO reviewed relevant laws and agency documents, analyzed patent and licensing data, and interviewed HHS officials, academic experts, industry representatives, and nongovernmental organizations. GAO is making two recommendations, including that NIH provide more information to the public about the licensing of its intellectual property. HHS concurred with GAO’s recommendations. For more information, contact John Neumann, (202) 512-6888, NeumannJ@gao.gov.
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    In U.S GAO News
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    In U.S GAO News
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    In U.S GAO News
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  • Covid-19: Key Insights from GAO’s Oversight of the Federal Public Health Response
    In U.S GAO News
    More than a year after the U.S. declared COVID-19 a public health emergency, the pandemic continues to result in catastrophic loss of life and substantial damage to the economy. It also continues to lay bare the fragmented nature of our public health sector, the fragility of the nation's medical supply chain, and longstanding disparities in health care access, treatment, and outcomes. GAO has made 44 recommendations to federal agencies. Of these recommendations, 16 relate to the following public health topics: COVID-19 Testing. GAO has made two recommendations to date to improve the federal government's efforts in diagnostic testing for COVID-19, critical to controlling the spread of the virus. In January 2021, GAO recommended that the Department of Health and Human Services (HHS) develop and make publicly available a comprehensive national COVID-19 testing strategy. Vaccines and Therapeutics. GAO has made two recommendations to improve transparency, communication, and coordination around the government's efforts to develop, manufacture, and distribute vaccines and therapeutics to prevent and treat COVID-19. For example, in September 2020, GAO recommended that HHS establish a time frame for a national vaccine distribution and administration plan that follows best practices, with federal and nonfederal coordination. Medical Supply Chain. GAO has made seven recommendations for the federal government to respond to vulnerabilities highlighted by the pandemic in the nation's medical supply chain, including limitations in personal protective equipment and other supplies necessary to treat individuals with COVID-19. In January 2021, GAO recommended that HHS establish a process for regularly engaging with Congress and nonfederal stakeholders as the agency refines and implements its supply chain strategy for pandemic preparedness, to include the role of the Strategic National Stockpile. COVID-19 Health Disparities. GAO has made three recommendations to improve COVID-19 data by race and ethnicity, as available data show communities of color bear a disproportionate burden of COVID-19 positive tests, cases, hospitalizations, and deaths. In September 2020, GAO recommended that the Centers for Disease Control and Prevention involve key stakeholders to help ensure the complete and consistent collection of demographic data. COVID-19 Data. GAO has made two recommendations to improve the collection of data needed to respond to COVID-19 and prepare for future pandemics. GAO recommended in January 2021 that HHS establish an expert committee to help systematically define and ensure the collection of standardized data across the relevant federal agencies and related stakeholders; the absence of such data hinders the ability of the government to respond to COVID-19, communicate the status of the pandemic with citizens, or prepare for future pandemics.  Although the responsible agencies generally agreed with the majority of the 16 recommendations, only one has been fully implemented. GAO maintains that implementing these recommendations will improve the federal government's public health response and ability to recover as a nation. As of February 17, 2021, the U.S. had about 27 million cumulative reported cases of COVID-19 and more than 486,000 reported deaths, according to the Centers for Disease Control and Prevention. The country also continues to experience serious economic repercussions. Five relief laws, including the CARES Act, have appropriated $3.1 trillion to address the public health and economic threats posed by COVID-19. The CARES Act also includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to COVID-19. This testimony summarizes GAO's insights from its oversight of the federal government's pandemic response in a series of comprehensive reports issued from June 2020 through January 2021. In particular, the statement focuses on the public health response, including testing, vaccines and therapeutics, medical supply chain, health disparities, and health data. GAO reviewed data, documents, and guidance from federal agencies about their activities and interviewed federal and state officials and stakeholders for the series of reports on which this testimony is based. See https://www.gao.gov/coronavirus/. GAO has made 44 recommendations for agencies and four matters for congressional consideration in its comprehensive series of bimonthly reports on the federal response to COVID-19 over the last year. GAO will issue its next report in this series in March 2021. For more information, contact A. Nicole Clowers at (202) 512-7114 or clowersa@gao.gov.
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