Utah Man Posing As Medical Doctor To Sell Baseless Coronavirus Cure Indicted On Fraud Charges

Company Formerly Associated with Defendant Agrees to Plead Guilty to Distributing Misbranded Drug Products and to Stop Marketing Silver Products as Coronavirus Treatment and Issue Refunds to Affected Consumers as Part of Global Resolution

Utah resident Gordon H. Pedersen has been indicted for posing as a medical doctor to sell a baseless treatment for coronavirus (COVID-19).  According to the indictment returned by a federal grand jury in Salt Lake City late last week, Pedersen fraudulently promoted and sold ingestible silver-based products as a cure for COVID-19 despite having no evidence that his products could treat or cure the disease.  Pedersen is also alleged to have claimed to be a physician and worn a stethoscope and white lab coat in videos and photos posted on the Internet to further his alleged fraud scheme.

In a related matter, the company Pedersen previously co-owned, My Doctor Suggests LLC (My Doctor Suggests), has agreed to plead guilty to a one-count criminal information related to its false and misleading marketing of ingestible silver products as a drug treatment for COVID-19.  The company has severed ties with Pedersen and agreed to cooperate in his prosecution.  The criminal information filed Thursday in the U.S. District Court for the District of Utah are part of a global resolution with My Doctor Suggests that also includes a civil consent order requiring the company to cease fraudulently labeling its products and to issue full refunds to affected consumers.

“The Department of Justice will take swift action to protect consumers from those who offer phony cure-alls for the treatment and prevention of COVID-19,” said Acting Assistant Attorney General Ethan Davis.  “We will continue to work closely with our partners at the Food and Drug Administration to quickly shut down schemes to promote and sell unlawful products during this pandemic.”

“In addition to the imposition of a civil restraining order that successfully shut down fraudulent claims of a COVID-19 cure-all, Mr. Pedersen now faces criminal charges for his conduct.  The federal felony allegations are serious, especially against the backdrop of this pandemic where Americans are yearning for effective relief.  If proven, this conduct reveals a scheme where greed was a higher priority than conveying truth to consumers,” said U.S. Attorney John W. Huber for the District of Utah.

The indictment against Pedersen alleges that, beginning in early 2020, he conducted a scheme to defraud consumers throughout the United States, by falsely presenting himself as a medical doctor and promoting and selling silver products on the Internet based on fraudulent claims of protection against, and treatment for, COVID-19, in the midst of a worldwide pandemic.

According to the criminal information filed Friday, My Doctor Suggests made false and misleading claims that the company’s silver-based products could be ingested to protect against COVID-19 and the products lacked the necessary directions for use as a drug product.  The information also allege My Doctor Suggests operated without properly registering with the Food and Drug Administration (FDA).  It is anticipated My Doctor Suggests will plead guilty to a single misdemeanor count of distributing misbranded drug products in interstate commerce in violation of the Food, Drug, and Cosmetic Act.

“The FDA is actively monitoring the marketplace for fraudulent products represented as preventing, curing, or treating COVID-19.  Americans expect and deserve treatments that are safe, effective and meet appropriate standards, and the agency will continue to bring to justice those who place profits above the public health during this pandemic,” said Judy McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs, U.S. Food and Drug Administration. “Today’s announcement should serve as a reminder that we will take action against those who jeopardize the health of Americans while taking advantage of a crisis.”

The Department of Justice previously sought and obtained an emergency court order in the U.S. District Court for the District of Utah, alleging in its civil complaint that My Doctor Suggests worked with two co-defendants, Pedersen and his company GP Silver LLC, to fraudulently promote and sell various silver products for the treatment and prevention of COVID-19.  Subsequent orders temporarily enjoined Pedersen, GP Silver LLC, and My Doctor Suggests from distributing silver products as well as representing they could cure, mitigate, treat, or otherwise prevent COVID-19 or any other disease. The recent consent order permanently enjoins My Doctor Suggests LLC from making these representations, and it provides a notification and refund process for deceived consumers.   

The consent order specifically requires that My Doctor Suggests LLC permanently stop any fraudulent promotions, clearly and conspicuously disavow any statement that its silver products treat or prevent COVID-19 in future marketing materials and consumer notices, implement robust compliance measures to prevent a reoccurrence, and provide full refunds upon request to any customer who purchased its silver products under fraudulent pretenses.  Affected customers can contact My Doctor Suggests LLC at (1-866- 660-9868) or refunds@mydoctorsuggests.com.

An indictment is an accusation by a federal grand jury and is not evidence of guilt.  The defendant should be presumed innocent unless and until proven guilty.

The criminal action is being prosecuted by Assistant U.S. Attorney Jacob Strain from the U.S. Attorney’s Office for the District of Utah with assistance from Trial Attorney Matt Lash from the Department of Justice, Civil Division’s Consumer Protection Branch and James Smith from the FDA’s Office of Chief Counsel.  The criminal case was investigated by the FDA’s Office of Criminal Investigations and the FBI’s Utah Field Office.

The civil enforcement action was handled by Trial Attorneys Speare I. Hodges and Sarah Williams of the Department of Justice, Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Joel A. Ferre, with support from FDA’s Office of Criminal Investigations.

Additional information about the Consumer Protection Branch and its enforcement efforts may be found at www.justice.gov/civil/consumer-protection-branch.  For more information about the U.S. Attorney’s Office for the District of Utah, visit its website at https://www.justice.gov/usao-ut.  For information about the Department of Justice’s efforts to stop illegal COVID-19-related activity, visit www.justice.gov/coronavirus.  For the most up-to-date information on COVID-19, consumers may visit the Centers for Disease Control and Prevention (CDC) and WHO websites. 

The public is urged to report suspected fraud schemes related to COVID-19 by calling the National Center for Disaster Fraud (NCDF) hotline (1-866-720-5721) or by e-mailing the NCDF at disaster@leo.gov.

The year 2020 marks the 150th anniversary of the Department of Justice.  Learn more about the history of our agency at www.Justice.gov/Celebrating150Years.

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    In 2013, the Transportation Security Administration (TSA) introduced the concept of third party testing—having an independent testing entity verify that a security screening system meets certain requirements. The concept is that screening system vendors would take this additional step either prior to submitting their technologies to TSA or if their system failed TSA's test and evaluation process. The goal is for third party testing to reduce the time and resources that TSA spends on its own testing. However, since introduced, TSA has directed only three vendors that failed TSA tests to use third party testing, with varying outcomes. In two other cases, TSA supplemented its test capabilities by using third party testers to determine that systems installed at airports were working properly. TSA officials and industry representatives pointed to several reasons for third party testing's limited use since 2013, such as the cost to industry to use third party testers and TSA's reluctance to date to accept third party test data as an alternative to its own. Despite this, TSA officials told GAO they hope to use third party testing more in the future. For example, in recent announcements to evaluate and qualify new screening systems, TSA stated that it will require a system that fails TSA testing to go to a third party tester to address the identified issues (see figure). Example of Use of Third Party Testing When a System Experiences a Failure in TSA's Testing TSA set a goal in 2013 to increase screening technology testing efficiency. In addition, TSA reported to Congress in January 2020 that third party testing is a part of its efforts to increase supplier diversity and innovation. However, TSA has not established metrics to determine third party testing's contribution toward the goal of increasing efficiency. Further, GAO found no link between third party testing and supplier diversity and innovation. Some TSA officials and industry representatives also questioned third party testing's relevance to these efforts. Without metrics to measure and assess the extent to which third party testing increases testing efficiency, TSA will be unable to determine the value of this concept. Similarly, without assessing whether third party testing contributes to supplier diversity and innovation, TSA cannot know if third party testing activities are contributing to these goals as planned. TSA relies on technologies like imaging systems and explosives detection systems to screen passengers and baggage to prevent prohibited items from getting on board commercial aircraft. As part of its process of acquiring these systems and deploying them to airports, TSA tests the systems to ensure they meet requirements. The 2018 TSA Modernization Act contained a provision for GAO to review the third party testing program. GAO assessed the extent to which TSA (1) used third party testing, and (2) articulated its goals and developed metrics to measure the effects of third party testing. GAO reviewed TSA's strategic plans, acquisition guidance, program documentation, and testing policies. GAO interviewed officials from TSA's Test and Evaluation Division and acquisition programs, as well as representatives of vendors producing security screening systems and companies providing third party testing services. GAO is recommending that TSA develop metrics to measure the effects of third party testing on efficiency, assess its effects on efficiency, and assess whether third party testing contributes to supplier diversity and innovation. DHS concurred with GAO's three recommendations and has actions planned to address them. For more information, contact Marie A. Mak at (202) 512-4841 or MakM@gao.gov.
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  • Chemical Security: Overlapping Programs Could Better Collaborate to Share Information and Identify Potential Security Gaps
    In U.S GAO News
    Eight federal programs addressing chemical safety or security from four departments or agencies that GAO reviewed contain requirements or guidance that generally align with at least half of the Department of Homeland Security's (DHS) 18 Chemical Facility Anti-Terrorism Standards (CFATS) program standards. At least 550 of 3,300 (16 percent) facilities subject to the CFATS program are also subject to other federal programs. Analyses of CFATS and these eight programs indicate that some overlap, duplication, and fragmentation exists, depending on the program or programs to which a facility is subject. For example, six federal programs' requirements or guidance indicate some duplication with CFATS. CFATS program officials acknowledge similarities among these programs' requirements or guidance, some of which are duplicative, and said that the CFATS program allows facilities to meet CFATS program standards by providing information they prepared for other programs. more than 1,600 public water systems or wastewater treatment facilities are excluded under the CFATS statute, leading to fragmentation. While such facilities are subject to other programs, those programs collectively do not contain requirements or guidance that align with four CFATS standards. According to DHS, public water systems and wastewater treatment facilities are frequently subject to safety regulations that may have some security value, but in most cases, these facilities are not required to implement security measures commensurate to their level of security risk, which may lead to potential security gaps. The departments and agencies responsible for all nine of these chemical safety and security programs—four of which are managed by DHS, three by the Environmental Protection Agency (EPA), and one each managed by the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) and the Department of Transportation (DOT)—have previously worked together to enhance information collection and sharing in response to Executive Order 13650, issued in 2013. This Executive Order directed these programs to take actions related to improving federal agency coordination and information sharing. However, these programs have not identified which facilities are subject to multiple programs, such that facilities may be unnecessarily developing duplicative information to comply with multiple programs. Although CFATS allows facilities to use information they prepared for other programs, CFATS program guidance does not specify what information facilities can reuse. Finally, DHS and EPA leaders acknowledged that there are differences between CFATS requirements and the security requirements for public water systems and wastewater treatment facilities, but they have not assessed the extent to which potential security gaps may exist. By leveraging collaboration established through the existing Executive Order working group, the CFATS program and chemical safety and security partners would be better positioned to minimize unnecessary duplication between CFATS and other programs and better ensure the security of facilities currently subject to fragmented requirements. Facilities with hazardous chemicals could be targeted by terrorists to inflict mass casualties or damage. Federal regulations applicable to chemical safety and security have evolved over time as authorizing statutes and regulations established programs for different purposes, such as safety versus security, and with different enforcement authorities. GAO has reported that such programs may be able to achieve greater efficiency where overlap exists by reducing duplication and better managing fragmentation. GAO was asked to review issues related to the effects that overlap, duplication, and fragmentation among the multiple federal programs may have on the security of the chemical sector. This report addresses the extent to which (1) such issues may exist between CFATS and other federal programs, and (2) the CFATS program collaborates with other federal programs. GAO analyzed the most recent available data on facilities subject to nine programs from DHS, EPA, ATF, and DOT; reviewed and analyzed statutes, regulations, and program guidance; and interviewed agency officials. GAO is making seven recommendations, including that DHS, EPA, ATF, and DOT identify facilities subject to multiple programs; DHS clarify guidance; and DHS and EPA assess security gaps. Agencies generally agreed with six; EPA did not agree with the recommendation on gaps. GAO continues to believe it is valid, as discussed in the report. For more information, contact Nathan Anderson at (206) 287-4804 or AndersonN@gao.gov.
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  • Native American Youth: Agencies Incorporated Almost All Leading Practices When Assessing Grant Programs That Could Prevent or Address Delinquency [Reissued with revisions on Aug. 27, 2020.]
    In U.S GAO News
    The Departments of Justice (DOJ), Health and Human Services (HHS), the Interior (Interior), and Education (Education) administered at least 38 grant programs from fiscal years 2015 through 2018 that could have helped prevent or address delinquency among Native American youth. These agencies made about $1.9 billion in awards to grantees through these programs during this period. These agencies incorporated almost all of the leading practices GAO identified for performance measurement or program evaluation when assessing the performance of selected grant programs. For example, HHS's Administration for Children and Families (ACF) incorporated 13 of the 14 leading practices for performance measurement but did not fully assess grantee data reliability for one of its programs. By developing a process to assess the reliability of grantee data contained in the annual performance reports that tribal recipients submit, ACF could obtain further assurance that it has an accurate representation of grantee performance. GAO also found that Interior's Bureau of Indian Education (BIE) did not conduct formal data reliability checks on performance data that grantees report and did not always collect performance reports from grantees in a timely manner for one of its programs. By developing a process to assess the reliability of a sample of grantee performance data and taking steps to alert grantees when they are late in submitting performance reports, BIE could better ensure that grantees are complying with the terms and conditions of the grant program and better understand how the program and its grantees are performing. Officials in all 12 interviews with tribes or tribal consortia GAO interviewed cited risk factors that contribute to juvenile delinquency in their communities. Number of Interviews in Which Tribal Officials Cited Risk Factors Contributing to Juvenile Delinquency Note: The figure includes the most common risk factors tribal officials cited for juvenile delinquency. While tribal officials cited restrictions placed on federal grant funding, difficulty communicating with program staff, and challenges hiring and retaining staff as barriers to implementing federal programs, they also identified promising practices, such as executing culturally relevant programs, for preventing or addressing juvenile delinquency. Federal and other studies have noted that exposure to violence and substance abuse make Native American youth susceptible to becoming involved with the justice system. GAO was asked to examine federal and tribal efforts to address juvenile delinquency and the barriers tribes face in doing so. This report examines (1) federal financial assistance targeting tribes that could prevent or address juvenile delinquency; (2) the extent to which federal agencies assess the performance of selected grant programs and incorporate leading practices; and (3) the juvenile delinquency challenges tribes report facing. GAO identified relevant grant programs during fiscal years 2015 through 2018—the most recent data available when GAO began the review. GAO analyzed documents and interviewed agency officials to determine how they assessed grant program performance and conducted interviews with 10 tribes and two tribal consortia to discuss challenges with delinquency. GAO is making three recommendations, including that relevant HHS and Interior offices develop a process to assess the reliability of tribal grantee performance information and that an Interior office take steps to alert grantees that are late in submitting progress reports. Interior concurred with the two recommendations. HHS disagreed with GAO's recommendation. GAO clarified the recommendation to HHS and continues to believe it is warranted. For more information, contact Gretta L. Goodwin, (202) 512-8777, or GoodwinG@gao.gov.
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  • Retirement Security: DOL Could Better Inform Divorcing Parties About Dividing Savings
    In U.S GAO News
    Although more than one-third of adults aged 50 or older have experienced divorce, few people seek and obtain a Qualified Domestic Relations Order (QDRO), according to large plan sponsors GAO surveyed. A QDRO establishes the right of an alternate payee, such as a former spouse, to receive all or a portion of the benefits payable to a participant under a retirement plan upon separation or divorce. There are no nationally representative data on the number of QDROs, but plans and record keepers GAO interviewed and surveyed reported that few seek and obtain QDROs. For example, the Pension Benefit Guaranty Corporation administered retirement benefits to about 1.6 million participants, and approved about 16,000 QDROs in the last 10 years. GAO's analysis of other survey data found about one-third of those who experienced a divorce from 2008 to 2016 and reported their former spouse had a retirement plan also reported losing a claim to that spouse's benefits. Many experts stated that some people—especially those with lower incomes—face challenges to successfully navigating the process for obtaining a QDRO, including complexity and cost. Individuals seeking a QDRO may be charged fees for preparation and review of draft orders before they are qualified as QDROs and, according to experts GAO interviewed, these fees vary widely. These experts cited concerns about QDRO review fees that they said in some cases were more than twice the amount of typical fees, and said they may discourage some from pursuing QDROs. Department of Labor (DOL) officials said the agency generally does not collect information on QDRO fees. Exploring ways to collect and analyze information from plans on fees could help DOL ensure costs are reasonable. Divorcing parties who pursue QDROs often had orders not qualified due to lacking basic information, according to plans and record keepers we surveyed (see figure). Plan Administrators and Record Keepers Reported Reasons for Not Qualifying a Domestic Relations Order (DRO) DOL provides some information to help divorcing parties pursue QDROs. However, many experts cited a lack of awareness about QDROs by the public and said DOL could do more to make resources available to divorcing parties. Without additional outreach by DOL, divorcing parties may spend unnecessary time and resources drafting orders that are not likely to be qualified, resulting in unnecessary expenditures of time and money. A domestic relations order (DRO) is a court-issued judgment, decree, or order that, when qualified by a retirement plan administrator, can divide certain retirement benefits in connection with separation or divorce and as such provide crucial financial security to a former spouse. DOL has authority to interpret QDRO requirements. GAO was asked to review the process for obtaining QDROs. This report examines what is known about (1) the number of QDRO recipients, (2) the fees and other expenses for processing QDROs, and (3) the reasons plans do not initially qualify DROs and the challenges experts identify regarding the QDRO process. To conduct this work, GAO analyzed available data, and a total of 14 responses from two surveys of large private sector plans and account record keepers, and interviewed 18 experts including practitioners who provide services to divorcing couples. GAO is recommending that DOL (1) explore ways to collect information on QDRO-related fees charged to participants or alternate payees, and (2) take steps to ensure information about the process for obtaining a QDRO is accessible. DOL generally agreed with our recommendations. For more information, contact Kris Nguyen at (202) 512-7215 or NguyenTT@gao.gov.
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  • Disaster Response: Agencies Should Assess Contracting Workforce Needs and Purchase Card Fraud Risk
    In U.S GAO News
    The efforts of selected agencies to plan for disaster contracting activities and assess contracting workforce needs varied. The U.S. Forest Service initiated efforts to address its disaster response contracting workforce needs while three agencies—the U.S. Army Corps of Engineers (USACE), the U.S. Coast Guard, and Department of the Interior (DOI)—partially addressed these needs. The Environmental Protection Agency indicated it did not have concerns fulfilling its disaster contracting responsibilities. Specifically, GAO found the following: USACE assigned clear roles and responsibilities for disaster response contracting activities, but has not formally assessed its contracting workforce to determine if it can fulfill these roles. The Coast Guard has a process to assess its workforce needs, but it does not account for contracting for disaster response activities. DOI is developing a strategic acquisition plan and additional guidance for its bureaus on how to structure their contracting functions, but currently does not account for disaster contracting responsibilities. Contracting officials at all three of these agencies identified challenges executing their regular responsibilities along with their disaster-related responsibilities during the 2017 and 2018 hurricane and wildfire seasons. For example, Coast Guard contracting officials stated they have fallen increasingly behind since 2017 and that future disaster response missions would not be sustainable with their current workforce. GAO's strategic workforce planning principles call for agencies to determine the critical skills and competencies needed to achieve future programmatic results. Without accounting for disaster response contracting activities in workforce planning, these agencies are missing opportunities to ensure their contracting workforces are equipped to respond to future disasters. The five agencies GAO reviewed from above, as well as the Federal Emergency Management Agency (FEMA), collectively spent more than $20 million for 2017 and 2018 disaster response activities using purchase cards. GAO found that two of these six agencies—Forest Service and EPA—have not completed fraud risk profiles for their purchase card programs that align with leading practices in GAO's Fraud Risk Framework. Additionally, five of the six agencies have not assessed or documented how their fraud risk for purchase card use might differ in a disaster response environment. DOI completed such an assessment during the course of our review. An Office of Management and Budget memorandum requires agencies to complete risk profiles for their purchase card programs that include fraud risk. GAO's Fraud Risk Framework states managers should assess fraud risk regularly and document those assessments in risk profiles. The framework also states that risk profiles may differ in the context of disaster response when managers may have a higher fraud risk tolerance since individuals in these environments have an urgent need for products and services. Without assessing fraud risk for purchase card programs or how risk may change in a disaster response environment, agencies may not design or implement effective internal controls, such as search criteria to identify fraudulent transactions. The 2017 and 2018 hurricanes and California wildfires affected millions of people and caused billions of dollars in damages. Extreme weather events are expected to become more frequent and intense due to climate change. Federal contracts for goods and services play a key role in disaster response and recovery, and government purchase cards can be used by agency staff to buy needed items. GAO was asked to review federal response and recovery efforts related to recent disasters. This report examines the extent to which selected agencies planned for their disaster response contracting activities, assessed their contracting workforce needs, and assessed the fraud risk related to their use of purchase cards for disaster response. GAO selected six agencies based on contract obligations for 2017 and 2018 disasters; analyzed federal procurement and agency data; reviewed agencies' policies on workforce planning, purchase card use, and fraud risk; and analyzed purchase card data. FEMA was not included in the examination of workforce planning due to prior GAO work. GAO is making 12 recommendations, including to three agencies to assess disaster response contracting needs in workforce planning, and to five agencies to assess fraud risk for purchase card use in support of disaster response. For more information, contact Marie A. Mak at (202) 512-4841 or makm@gao.gov.
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