Former Medical Director of Suboxone Manufacturer Indivior Sentenced in Connection with Drug Safety Claims

Timothy Baxter, the former medical director of Indivior PLC, was sentenced today in federal court in Abingdon, Virginia, to six months of home detention and 100 hours of community service in connection with the company’s marketing of an opioid drug.

Baxter pleaded guilty in August 2020 to a one-count misdemeanor Information related to Indivior’s false and misleading representations to the Massachusetts Medicaid program (MassHealth) regarding Suboxone, a drug approved for recovering opioid addicts to avoid or reduce withdrawal symptoms. In connection with his guilty plea to causing the introduction into interstate commerce of misbranded drugs under the Federal Food, Drug, and Cosmetic Act, Baxter admitted that he failed to prevent Indivior from sending false and misleading information to MassHealth related to the relative safety of Suboxone Film, a version of Suboxone, around children. 

“In this administration, the Department of Justice has augmented its important and ongoing drug enforcement efforts with a series of new initiatives targeted at illegal conduct involving prescription opioid drugs,” said Deputy Attorney General Jeffrey A. Rosen.  “The Department’s multi-pronged prosecution of Indivior’s unlawful promotion of Suboxone is a prime example of how to combat this crisis through diverse strategies.  The net effect of the Department’s Indivior-related cases will bolster ongoing efforts to punish criminal conduct in the opioid space, deter further criminal conduct among opioid manufacturers and their top executives, and contribute significantly to the Department’s objective to stem the tide of this epidemic.”

“When Timothy Baxter failed to ensure Indivior provided honest and accurate information to a state Medicaid program about Suboxone, it resulted in overstated safety claims and criminal conduct,” said Acting U.S. Attorney Daniel P. Bubar.  “Baxter’s failure was especially egregious, given his role in the company as global medical director.  Today’s sentence ought to be a deterrent to other pharmaceutical executives against providing anything less than truthful information about their products.  We could not have done this case without the hard work of and cooperation with the Virginia Attorney General’s Office and our federal partners, for which we are incredibly grateful.” 

“The Opioid crisis continues to be a critical public health issue with the toll of addiction—in lost lives and broken families—affecting every community in America. Addressing this crisis is one of the FDA’s highest priorities,” said FDA Commissioner Stephen M. Hahn, M.D. “Medication-assisted treatments incorporating drugs like Indivior’s Suboxone, in combination with counseling and behavioral therapy, are an important tool in combating opioid use disorder but can quickly become part of the problem if not used responsibly. When companies and their leadership provide misleading information about relative product benefits, they can ultimately risk more misuse, abuse, diversion, and accidental exposure to opioid drugs as well as make treatment more difficult to obtain for those suffering from this crisis. We will continue to work with the Department of Justice to investigate and hold accountable those who devise and participate in schemes to the detriment of the public health.”

According to court documents, Baxter helped oversee Indivior’s efforts in 2012 to secure formulary coverage for Suboxone Film from MassHealth. Indivior employees devised a strategy to win preferred drug status for Suboxone Film and counteract a non-opioid competitor MassHealth was considering for opioid-addiction treatment. A certain Indivior employee subsequently shared false and misleading safety information with MassHealth officials about Suboxone Film’s risk of accidental pediatric exposure. Baxter failed to prevent this course of conduct carried out by an employee under his supervision. Two months after receiving that false and misleading information, MassHealth announced it would provide access to Suboxone Film for Medicaid patients with children under the age of six.

Indivior’s former CEO, Shaun Thaxter, was sentenced in October 2020 to six months in prison and a $600,000 criminal fine and forfeiture after he pleaded guilty to the same charge. U.S. District Court Judge James P. Jones of the Western District of Virginia handed down the sentences for both Baxter and Thaxter. The cases follow corporate criminal and civil resolutions announced by the Department earlier this year. In total, payments made by Indivior Solutions and its parent companies, Indivior Inc. and Indivior plc, along with payments made under a 2019 resolution with Indivior’s former parent, Reckitt Benckiser Group plc, will exceed $2 billion. That amount represents the second-largest monetary resolution obtained by the Department of Justice in a case involving an opioid drug.

The criminal case against Indivior was prosecuted by the U.S. Attorney’s Office for the Western District of Virginia; the Department of Justice Civil Division’s Commercial Litigation Branch; the Department of Justice Civil Division’s Consumer Protection Branch; the Virginia Medicaid Fraud Control Unit of the Office of the Virginia Attorney General; and the Federal Trade Commission.  This matter was investigated by the Virginia Attorney General’s Medicaid Fraud Control Unit; FDA’s Office of Criminal Investigation; the United States Postal Service Office of Inspector General; and the Department of Health and Human Services Office of Inspector General.

The joint effort advances the goals of the Department’s Prescription Interdiction & Litigation (PIL) Task Force to deploy all available criminal, civil, and regulatory tools to hold opioid manufacturers accountable for unlawful practices and to ensure that prescription opioid products are marketed truthfully. 

For more information about the U.S. Attorney’s Office for the Western District of Virginia, visit its website at https://www.justice.gov/usao-wdva. Additional information about the Consumer Protection Branch and the Civil Fraud Section and their enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch and http://www.justice.gov/civil/fraud-section. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).

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    In April 2020, the Small Business Administration (SBA) moved quickly to implement the Paycheck Protection Program (PPP), which provides loans that are forgivable under certain circumstances to small businesses affected by COVID-19. Given the immediate need for these loans, SBA worked to streamline the program so that lenders could begin distributing these funds as soon as possible. For example, lenders were permitted to rely on borrowers' self-certifications for eligibility and use of loan proceeds. As a result, there may be significant risk that some fraudulent or inflated applications were approved. Since May 2020, the Department of Justice has publicly announced charges in more than 50 fraud-related cases associated with PPP funds. In April 2020, SBA announced it would review all loans of more than $2 million to confirm borrower eligibility, and SBA officials subsequently stated that they would review selected loans of less than $2 million to determine, for example, whether the borrower is entitled to loan forgiveness. However, SBA did not provide details on how it would conduct either of these reviews. As of September 2020, SBA reported it was working with the Department of the Treasury and contractors to finalize the plans for the reviews. Because SBA had limited time to implement safeguards up front for loan approval, GAO believes that planning and oversight by SBA to address risks in the PPP program is crucial moving forward. SBA's efforts to expedite processing of Economic Injury Disaster Loans (EIDL)—such as the reliance on self-certification—may have contributed to increased fraud risk in that program as well. In July 2020, SBA's Office of Inspector General (OIG) reported indicators of widespread potential fraud—including thousands of fraud complaints—and found deficiencies with SBA's internal controls. In response, SBA maintained that its internal controls for EIDL were robust, including checks to identify duplicate applications and verify account information, and that it had provided banks with additional antifraud guidance. The Department of Justice, in conjunction with other federal agencies, also has taken actions to address potential fraud. Since May 2020, the department has announced fraud investigations related to the EIDL program and charges against recipients related to EIDL fraud. SBA has made or guaranteed more than 14.5 million loans and grants through PPP and EIDL, providing about $729 billion to help small businesses adversely affected by COVID-19. However, the speed with which SBA implemented the programs may have increased their susceptibility to fraud. This testimony discusses fraud risks associated with SBA's PPP and EIDL programs. It is based largely on GAO's reports in June 2020 (GAO-20-625) and September 2020 (GAO-20-701) that addressed the federal response, including by SBA, to the economic downturn caused by COVID-19. For those reports, GAO reviewed SBA documentation and interviewed officials from SBA, the Department of the Treasury, and associations that represent lenders and small businesses. GAO also met with officials from the SBA OIG and reviewed OIG reports. In its June 2020 report, GAO recommended that SBA develop and implement plans to identify and respond to risks in PPP to ensure program integrity, achieve program effectiveness, and address potential fraud. SBA neither agreed nor disagreed, but GAO believes implementation of this recommendation is essential. For more information, contact William B. Shear at (202) 512-4325 or shearw@gao.gov.
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    Why This Matters Contact tracing can help reduce transmission rates for infectious diseases like COVID-19 by identifying and notifying people who may have been exposed. Contact tracing apps, notably those using proximity tracing, could expedite such efforts. However, there are challenges, including accuracy, adoption rates, and privacy concerns. The Technology What is it? Contact tracing is a process in which public health officials attempt to limit disease transmission by identifying infected individuals, notifying their "contacts"—all the people they may have transmitted the disease to—and asking infected individuals and their contacts to quarantine, if appropriate (see fig. 1). For a highly contagious respiratory disease such as COVID-19, a contact could be anyone who has been nearby. Proximity tracing applications (apps) can expedite contact tracing, using smartphones to rapidly identify and notify contacts. Figure 1. A simplified depiction of disease transmission. Through contact tracing, an infected individual’s contacts are notified and may be asked to quarantine. (In reality, some contacts may not become infected, and some of those infected may not show symptoms.) How does it work? In traditional contact tracing, public health officials begin by identifying an infected individual. They then interview the individual to identify recent contacts, ask the individual and their contacts to take containment measures, if appropriate (e.g., a 14-day quarantine for COVID-19), and coordinate any needed care and testing. Proximity tracing apps may accelerate the process by replacing the time-consuming interviews needed to identify contacts. Apps may also identify more contacts than interviews, which rely on interviewees' recall and on their being acquainted with their contacts. Public health authorities provide the apps, often using systems developed by companies or research groups. Users voluntarily download the app for their country or region and opt in to contact tracing. In the U.S., state or local public health authorities would likely implement proximity tracing apps. Proximity tracing apps detect contacts using Bluetooth, GPS, or a combination of both. Bluetooth-based apps rely on anonymous codes shared between smartphones during close encounters. These codes contain no information about location or user identity, helping safeguard privacy. The apps allow public health authorities to set a minimum time and distance threshold for someone to count as a contact. Contact tracing can be centralized or decentralized. With a centralized approach, contacts identified by the app are often saved to a government server, and an official notifies contacts of possible exposure. For a decentralized approach, contact data are typically stored on the user's device at first. When a user voluntarily reports infection, the user's codes are uploaded to a database that other app users' phones search. Users who have encountered the infected person then receive notifications through the app (see fig. 2). Figure 2. Bluetooth-based proximity tracing apps exchange information, notify contacts exposed to an infected person, and provide follow-up information. How mature is it? Traditional contact tracing is well established and has been an effective infectious disease response strategy for decades. Proximity tracing apps are relatively new and not as well established. Their contact identifications could become more accurate as developers improve app technology, for example by improving Bluetooth signal interpretation or using information from other phone sensors. Opportunities Reach more people. For accurate COVID-19 contact tracing using traditional methods, public health experts have estimated that the U.S. would require hundreds of thousands of trained contact tracers because of the large number of infections. Proximity tracing apps can expedite and automate identification and notification of the contacts, reducing this need. Faster response. Proximity tracing apps could slow the spread of disease more effectively because they can identify and notify contacts as soon as a user reports they are infected. More complete identification of contacts. Proximity tracing apps, unlike traditional contact tracing, do not require users to recall or be acquainted with people they have recently encountered. Challenges Technology. Technological limitations may lead to missed contacts or false identification of contacts. For example, GPS-based apps may not identify precise locations, and Bluetooth apps may ignore barriers preventing exposure, such as walls or protective equipment. In addition, apps may overlook exposure if two people were not in close enough proximity long enough for it to count as a contact. Adoption. Lower adoption rates make the apps less effective. In the U.S., some states may choose not to use proximity tracing apps. In addition, the public may hesitate to opt in because of concerns about privacy and uncertainty as to how the data may be used. Recent scams using fake contact tracing to steal information may also erode trust in the apps. Interoperability. Divergent app designs may lead to the inability to exchange data between apps, states, and countries, which could be a problem as travel restrictions are relaxed. Access. Proximity tracing apps require regular access to smartphones and knowledge about how to install and use apps. Some vulnerable populations, including seniors, are less likely to own smartphones and use apps, possibly affecting adoption. Policy Context and Questions Although proximity tracing apps are relatively new, they have the potential to help slow disease transmission. But policymakers will need to consider how great the benefits are likely to be, given the challenges. If policymakers decide to use proximity tracing apps, they will need to integrate them into the larger public health response and consider the following questions, among others: What steps can policymakers take to build public trust and encourage communities to support and use proximity tracing apps, and mitigate lack of adoption by some populations? What legal, procedural, privacy, security, and technical safeguards could protect data collected through proximity tracing apps? What can policymakers do to improve coordination of contact tracing efforts across local, state, and international jurisdictions? What can policymakers do to expedite testing and communication of test results to maximize the benefits of proximity tracing apps? What can policymakers do to ensure that contact identification is accurate and that its criteria are based on scientific evidence? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov.
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