Teach repercussions that follow as the FDA pursues Suboxone case for fraudulent opioid marketing.
About the Author:
My name is Joshua McCarty. I am a Freelance Videographer. I make films to bring awareness to important subjects that occur within the world. In 2007 I was incarcerated because I thought I was smarter than the people I attempted to deceive. This thinking caused me to go to prison for six years. I spent those six years rebuilding myself mentally and started to develop healthier thinking habits. Since my release, I have graduated from college with an Associate’s Degree in Human Resource Management and will be furthering my education.
Upon completion of this Case Study, participants will be able to:
- Describe penalties for falsifying documents.
- Understand grand jury proceedings.
- Explain how government investigations may begin.
- Identify ways to speak up when discovering illegal activity within a company.
People employed in the public health industry.
Suboxone, Indivior, FDA, Baxter, Indictment.
Current State of the Industry:
The prescription drug industry is a powerful force in the United States, generating tens of billions of dollars in profits each year. It’s no accident that drug use and abuse has risen in tandem, becoming more prevalent. People may be prescribed various narcotics to treat an ailment and then find themselves dependent on continued use of the medication. Substance abuse costs the US healthcare system billions of dollars annually. Addiction to over-the-counter medications and illegal substances has impacted many families and caused a multitude of drug-related deaths due to overdose. Though some substance abuse disorders are reparative, others prove better treated with different medications to impede the addiction.
Addiction support and prevention groups and clinics have sprouted up throughout the United States to treat this epidemic. These clinics have a clear understanding of medications that can be used for preventative purposes. Unfortunately, some clinics value self-enrichment over the health concerns and lives of others. This selfishness has caused concern within the healthcare system and garnered the attention of law enforcement officials. Strict guidelines have been put in place to ensure that patients overcoming drug addiction will not be taken advantage of and have access to proper solutions. These solutions may hopefully assist them with their dependency.
Future State of the Industry:
Business leaders should make decisions that benefit their customers, not merely ones that drive corporate profit. They should have stringent rules and guidelines in place that subordinates must follow in order to ensure the safety of everyone involved. Ethical decisions help build camaraderie within the company and rapport with their clients. Acting morally contrary and failing to exercise sound judgment breaks the trust they have with consumers and the public at large. It also piques the interest of government investigators who remain particularly keen on prosecuting cases in this publicly sensitive area, especially since the US life expectancy rate even experienced a downturn for several years, due to skewed results from overdose deaths. When corruption exists within a company, senior executives should speak against it to maintain the morals within themselves and the company. Regrettably, some business leaders choose silence. This neglectful mindset risks the health and lives of many. Silence and greed when illicit activity is occurring can lead to government investigations that may cause forfeiture of position and prison time.
The medical director of global pharmaceutical company remained silent as his company began producing false information about a certain opioid. The medical director watched as others within the company misled patients and the Food and Drug Administration (FDA) concerning the safety of narcotics they sold.
An investigation began, initiated by federal prosecutors with assistance from the FDA. All parties involved now face significant prison time and criminal fines.
Congress created the Food and Drug Administration to protect the health of all Americans. The FDA regulates what products comes through the marketplace for human consumption. When food or drug products are manufactured, the FDA has established requirements in order for those items to be approved. Due to the nature of this regulatory process, not all drugs gain approval.
Indivior, a worldwide medical company specializes in producing a drug called Suboxone. Doctors frequently prescribed Suboxone to help treat patients with pre-existing drug addictions, to help minimize their dependency.
Timothy Baxter was the top executive at Indivior. Baxter’s duties included sales and marketing of Indivior’s products. However, his position of responsibility also required ensuring the well-being of consumers and to provide accurate, up to date information regarding drugs manufactured and released by Indivior. Indivior promoted use of its drugs to doctors for patient treatment and profited handsomely as sales of Suboxone took off.
MassHealth, a company in Massachusetts operated as a Medicaid and Health Insurance institution. MassHealth provided prescription drugs, hospital visits and other important health services to their patients. MassHealth relied upon Indivior and its international reputation in deciding to prescribe the company’s drugs for commercial use, instead of using alternative treatment methods.
While Suboxone provides solid treatment against addiction for many people, the drug may not be appropriate for everyone. Doctors readily prescribed Suboxone when they believed a patient’s addiction warranted, but Indivior felt it could improve sales via a campaign directly targeted at consumers. Indivior devised a strategy that would urge patients towards physicians more inclined to write a prescription for Suboxone. This subterfuge marketing occurred for years under the leadership of Baxter. Baxter had full knowledge of this marketing tactic from Indivior but refused to say anything about it. His negligence to speak put many patients who used Suboxone at risk. Indivior would provide misleading documents to MassHealth to ensure them that Suboxone was extremely safe for consumption to a wider range of patients than met the criteria. Indivior used hyperbole concerning Suboxone to have it prescribed to patients more frequently. These false descriptions helped Indivior become a medicine of first preference whenever doctors needed to write a prescription.
All of this took place under the direct supervision of Baxter but, as prosecutors came to believe, Baxter did not act alone. Former Chief Executive Officer of Indivior, Shaun Thaxter, also came under investigation. Thaxter became aware of the campaign Baxter ran but remained silent. The government brought charges and both Baxter and Thaxter pled guilty to providing ambiguous information to MassHealth for Suboxone to gain preferential status.
Considering the circumstances, Timothy Baxter’s position with Indivior placed him a position of trust both to the company and society at large. While profits drive corporate actions, those actions must be tempered by concerns of consumer health and potential legal liability. Baxter enabled a marketing campaign labelled as helping to solve addiction yet created an entirely separate addiction to his Indivior’s products.
The manipulation tactics used by Indivior put many patients at risk. MassHealth prescribed Suboxone to patients solely based on that safety information provided to them by Indivior. MassHealth remained ignorant to the fact that Indivior provided inaccurate and overstated information with respect to Suboxone.
Baxter, Thaxter and the entire company of Indivior faced material repercussions as a result of their fraudulent actions and failure to have sufficient controls in place to prevent such actions. They all plead guilty with Baxter and Thaxter getting incarcerated and paying material fines. Indivior itself paid a fine of $2 billion to resolve this issue.
Failure to properly balance the corporate goal of profits against health concerns proved to be the root cause of Indivior’s problems. Many companies face similar decisions daily with corporate executives left to their own devices in making a determination. While no company can effectively micro-manage each decision, they can take it upon themselves to build a solid corporate culture that encourages compliant decision making. The company had ample time and opportunity to stop the misleading information coming from Indivior. Baxter could and should have done something to change the direction and tone of the marketing campaign. Yet, due to lack of a moral internal corporate compass, he failed to do so.
Business leaders must concern themselves with all aspects of their company in order to protect themselves, fellow employees, consumers and the company as a whole. Effecting a mindful corporate compliance program that emphasizes doing the right thing even when it may impact short-term profits is of paramount importance. Short-term profits can quickly and easily turn into material long-term losses when bad decisions are made. It can also lead to loss of personal freedom. Corporate leaders must take action to prevent fraud once it may be discovered in order to best protect everyone in the organization.