Opioid Manufacturer Indivior’s Former Global Medical Director Pleads Guilty In Connection With Drug Safety Claims
ABINGDON, VIRGINIA – Timothy Baxter, the former global medical director of Indivior, pleaded guilty today in U.S. District Court in Abingdon to a one-count misdemeanor information charging him with causing the introduction into interstate commerce of the opioid drug Suboxone Film, which was misbranded in violation of the Federal Food, Drug, and Cosmetic Act. Indivior’s former chief executive officer, Shaun Thaxter, recently pleaded guilty to a similar charge.
Baxter was the top medical executive of Indivior (formerly known as Reckitt Benckiser Pharmaceuticals) from 2000 until he left the company in May 2016. Indivior and one of its subsidiaries have agreed to pay $600 million to resolve their criminal and civil liability, with the subsidiary pleading guilty to making false statements relating to health care matters. Indivior’s former parent company, Reckitt Benckiser Group, previously paid $1.4 billion to resolve its liability.
Suboxone Film is a drug approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms while they undergo drug-addiction treatment. Suboxone and its active ingredient, buprenorphine, are powerful and addictive opioids.
According to court documents, Baxter admitted that an Indivior employee he supervised sent inaccurate drug-safety information to the Massachusetts Medicaid agency, MassHealth, in 2012. More specifically:
- Baxter was familiar with the issue of unintended pediatric exposure – meaning children taking drugs by accident – and worked on it over several years.
- In 2012, Indivior had a contractor collect data on unintended pediatric exposure to buprenorphine drugs, with Baxter approving the project.
- In October 2012, an Indivior medical affairs manager who Baxter supervised met with MassHealth, and urged it to expand its coverage of Suboxone Film. In connection with the meeting, the medical affairs manager asked Indivior’s contractor for data on unintended pediatric exposure for data on Massachusetts. The contractor sent the data to the medical affairs manager. The data showed that other buprenorphine drugs – not Suboxone Film – had the lowest rate of unintended pediatric exposure in Massachusetts. But the medical affairs manager changed the data to make it appear that Suboxone Film had the lowest rate of unintended pediatric exposure in Massachusetts, and emailed the altered, inaccurate data to MassHealth. The medical affairs manager forwarded the email to Baxter, stating, “I hope this helps us get some movement” on expanding MassHealth coverage of Suboxone Film.
- Then in November 2012, the medical affairs manager emailed MassHealth an incomplete graph that intentionally omitted more data on unintended pediatric exposure that was arguably unfavorable to Suboxone Film. Baxter did not receive the email; but in another context, Baxter approved of using a similarly incomplete graph.
- Then, the following quarter, the medical affairs manager received still more data showing that other buprenorphine drugs had lower rates of unintended pediatric exposure than Suboxone Film in Massachusetts. The medical affairs manager withheld the data from MassHealth, and later stated in a speech at an Indivior corporate conference that her rationale was “don’t ask, don’t tell.”
- In December 2012, MassHealth announced that it would expand coverage of Suboxone Film for patients with children under the age of six.
- With Baxter’s approval, Indivior sent a correction letter to MassHealth in December 2015. By that time, the company had come under government investigation.
“Pharmaceutical company executives have a responsibility to ensure that their products are truthfully marketed, especially when those products are addictive opioids,” said Deputy Assistant Attorney General Daniel J. Feith of the Civil Division’s Consumer Protection Branch. “The Department of Justice will vigilantly protect public health by investigating and pursuing conduct associated with false and misleading drug claims.”
“Health care providers and insurers rely on pharmaceutical manufacturers for honesty and accuracy when they provide information, which is particularly crucial when a company markets a powerful opioid,” First Assistant Daniel Bubar said today. “Timothy Baxter failed to ensure Indivior provided accurate information to a major insurance provider. This is especially troubling, given Baxter’s long-time role as global medical director for the company. I am again proud of the extensive efforts of the investigative team, which shows we will not tolerate companies or executives who break the law by placing profits over honesty.”
“The opioid crisis has devastated families and communities across Virginia and around the country,” said Virginia Attorney General Mark Herring. “Opioid manufacturers and their executive leadership capitalized off of the opioid epidemic to sell more product, putting profits over safety. I am proud of the work my Medicaid Fraud Control Unit has done on these important cases and I want to thank our local, state and federal partners for their continued partnership.”
“Opioid addiction and abuse is a serious public health crisis and addressing it is one the FDA’s highest priorities. Providing misleading information about drugs used to treat opioid addiction could ultimately exacerbate the problem by making these treatments more difficult to obtain,” said Catherine Hermsen, Assistant Commissioner of the FDA’s Office of Criminal Investigations. “We will continue to work with the Department of Justice to investigate and hold accountable those who devise and participate in fraud schemes to the detriment of the public health.”
“The multiple Indivior prosecutions illustrate the hard work and dedication of investigators who focused on the case,” said Elton Malone, Assistant Inspector General for Investigations with the Office of Inspector General of the U.S. Department of Health and Human Services. “This resolution is emblematic of law enforcement’s continued focus on this opioid epidemic, and serves as a warning to those who would flout the law.”
“The Postal Service spends billions of dollars per year on health care related costs for its employees. It is the responsibility of special agents with the USPS OIG to ensure those dollars are paid to providers that follow the rules and regulations, and don’t try to cheat the government,” said U.S. Postal Service Office of Inspector General (USPS OIG) Special Agent in Charge Kenneth Cleevely, Eastern Area Field Office. “When we discover someone is trying to obtain money they are not entitled to, we will aggressively pursue them in coordination with our law enforcement partners, and seek their criminal prosecution when appropriate. This case should serve notice to other pharmaceutical providers that we are watching you, and we will find you if you try to cheat.”
The case against Baxter is being prosecuted by attorneys from the U.S. Attorney’s Office for the Western District of Virginia, Virginia Attorney General’s Office, and the Department of Justice Civil Division’s Commercial Litigation Branch and Consumer Protection Branch, including Albert P. Mayer, Randy Ramseyer, Kristin L. Gray, Joseph S. Hall, Janine M. Myatt, Garth W. Huston, Carol Wallack, Jill P. Furman, Charles J. Biro, and Matthew J. Lash. The investigation of Baxter was handled by the FDA’s Office of Criminal Investigations; the Virginia Medicaid Fraud Control Unit; the United States Postal Service- Office of Inspector General; and the U.S. Department of Health and Human Services - Office of Inspector General. Assistance was provided by representatives of the FDA’s Office of Chief Counsel.