Avanos Medical Inc. to Pay $22 Million to Resolve Criminal Charge Related to the Fraudulent Misbranding of Its MicroCool Surgical Gowns

Avanos Medical Inc., a U.S.-based multinational medical device corporation, has agreed to pay more than $22 million to resolve a criminal charge relating to the company’s fraudulent misbranding of its MicroCool surgical gowns.

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    In U.S GAO News
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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. 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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
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    In U.S GAO News
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  • Department of Justice Highlights Work Combating Anti-Semitic Acts
    In Crime News
    Today, Deputy Attorney General Jeffrey A. Rosen presented remarks highlighting the Department of Justice’s work combating anti-Semitic acts at a virtual conference hosted by Secretary of State Michael Pompeo entitled “Ancient Hatred, Modern Medium”—the first ever government-sponsored event focused on online anti-Semitism. Deputy Attorney General Rosen described just a few of the Department of Justice’s many recent accomplishments in combating anti-Semitism, focusing on social media and the internet. His remarks as prepared for delivery are available here, and the full State Department conference may be viewed here.
    [Read More…]
  • Secretary Blinken’s Meeting with Japanese Foreign Minister Motegi and Republic of Korea Foreign Minister Chung
    In Crime Control and Security News
    Office of the [Read More…]
  • Remarks by Principal Deputy Assistant Attorney General Jonathan D. Brightbill at the American Bar Association’s Environmental & Energy Litigation Federal Updates Virtual Regional CLE Program
    In Crime News
    Remarks as Prepared for [Read More…]
  • On the United Kingdom’s Establishment of a Global Anti-Corruption Sanctions Regime
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • District Court Orders Washington State Company and its Owner to Stop Distributing Adulterated Juice Products
    In Crime News
    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.
    [Read More…]
  • Justice Department Invests $2.6 Million to Mitigate Violent Crime and Support Public Safety in Disruption Efforts
    In Crime News
    The Department of Justice announced awards from the Office of Justice Programs (OJP) totaling $2.6 million to four jurisdictions to disrupt and mitigate threats of violence.  The funds support state and local prosecutors and investigators who seek expertise from mental health and threat assessment experts to identify these individuals and prevent violent acts.
    [Read More…]
  • Virginia Tax Preparer Sentenced to More Than Two Years in Prison for Preparing False Returns
    In Crime News
    A Newport News, Virginia, tax return preparer was sentenced to 27 months in prison for preparing false tax returns, announced Principal Deputy Assistant Attorney General Richard E. Zuckerman of the Justice Department’s Tax Division and U.S. Attorney G. Zachary Terwilliger for the Eastern District of Virginia.
    [Read More…]
  • Former Veterans Affairs Doctor Pleads Guilty to Three Civil Rights Offenses
    In Crime News
    A doctor of osteopathic medicine who formerly worked at the Veterans Affairs (VA) Medical Center in Beckley, West Virginia, pleaded guilty today to three counts of depriving veterans of their civil rights under color of law by sexually abusing them.
    [Read More…]
  • Former Minister of Industry and Member of Parliament of Barbados Sentenced for Laundering Bribes
    In Crime News
    A former Minister of Industry and elected member of Parliament of Barbados was sentenced today to two years in prison for his role in a scheme to launder bribe payments from a Barbadian insurance company through bank accounts in New York.
    [Read More…]
  • Elections in El Salvador
    In Crime Control and Security News
    Ned Price, Department [Read More…]
  • Public Health Preparedness: HHS Has Taken Some Steps to Implement New Authority to Speed Medical Countermeasure Innovation
    In U.S GAO News
    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. 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.
    [Read More…]
  • The United States and United Kingdom: Reaffirming Our Alliance
    In Crime Control and Security News
    Office of the [Read More…]
  • Department Press Briefing – February 17, 2021
    In Crime Control and Security News
    Ned Price, Department [Read More…]
  • Man Sentenced to 97 months in Prison for Role in International Credit Card Fraud and Money Laundering Conspiracy
    In Crime Control and Security News
    U.S. Attorney’s Office [Read More…]
  • This Week in Iran Policy
    In Crime Control and Security News
    Office of the [Read More…]
  • Department of Justice Publishes Proposed Regulations Articulating the Registration Requirements for Sex Offenders under the Sex Offender Registration and Notification Act
    In Crime News
    The Department of Justice has published proposed regulations that provide a clear and comprehensive statement of sex offenders’ registration requirements under the federal Sex Offender Registration and Notification Act (SORNA).  SORNA requires convicted sex offenders to register in the states in which they live, work, or attend school, and it directs the Attorney General to issue regulations and guidelines to implement SORNA. 
    [Read More…]
  • Beam Suntory Inc. Agrees to Pay Over $19 Million to Resolve Criminal Foreign Bribery Case
    In Crime News
    Beam Suntory Inc. (Beam), a Chicago-based company that produces and sells distilled beverages, has agreed to pay a criminal monetary penalty of $19,572,885 to resolve the department’s investigation into violations of the Foreign Corrupt Practices Act (FCPA).
    [Read More…]
  • Judiciary Launches Redesigned PACER Website
    In U.S Courts
    The Administrative Office of the U.S Courts on June 28 will launch a redesigned informational website for the Judiciary’s electronic court records system, known as PACER (Public Access to Court Electronic Records).
    [Read More…]
  • Remarks by Attorney General William P. Barr at the Major Cities Chiefs Association Conference
    In Crime News
    I appreciate the invitation to address this group.  I want to start by thanking you, and the men and women you lead, for serving in what I think is the most noble profession in our country – enforcing the law and keeping our communities safe. 
    [Read More…]
  • Justice Department Settles with North Carolina Dental Offices Over HIV Discrimination
    In Crime News
    The Justice Department announced today that it has reached a settlement to resolve a claim that Night and Day Dental Inc. discriminated against a woman with HIV in violation of the Americans with Disabilities Act (ADA). 
    [Read More…]
  • Ensuring a Transparent, Thorough Investigation of COVID-19’s Origin
    In Crime Control and Security News
    Michael R. Pompeo, [Read More…]
  • Justice Department Settles with a Car Rental Services Company to Resolve Immigration-Related Discrimination
    In Crime News
    The Justice Department announced today that it signed a settlement agreement with Fleetlogix Inc. (Fleetlogix) resolving claims that the company discriminated against work-authorized non-U.S. citizens by requiring them to provide specific and unnecessary work authorization documentation because of their citizenship or immigration status. Fleetlogix, based in San Diego, California, operates offices nationwide that provide cleaning and transportation services to rental car companies.
    [Read More…]
  • Secretary Antony J. Blinken at the U.S. International Development Finance Corporation
    In Crime Control and Security News
    Antony J. Blinken, [Read More…]
  • Declining Media Pluralism in Hungary
    In Crime Control and Security News
    Ned Price, Department [Read More…]