Those active in the fight against the nation’s opioid crisis have yet another thing to worry about: opioid lollipops.
Now, a former pharmaceutical sales representative has taken on the role of whistleblower, revealing what he knows about off-label marketing of the dangerous and addictive form of fentanyl.
Bruce Boise, who formerly worked as a pharmaceutical sales rep for Cephalon, was the person responsible for exposing the company’s off-label marketing of its product. Called Actiq, the product contains fentanyl, a painkiller 100 times more powerful than morphine, and delivers it in a format made to be used like a lollipop.
Boise’s case began when he refused to follow his employer’s orders to convince doctors to prescribe Actiq and other drugs for off-label use. He claimed he had concerns the sales practices were illegal and that off-label prescriptions of Actiq were dangerous for patients. When his concerns were not addressed and marketing policies were not changed, Boise contacted the Food and Drug Administration (FDA) to inform them of what the company was doing.
Boise has since been public with his claims and has spoken to several news outlets, including CBS This Morning. His story was recently featured on Whistleblower, hosted by Judge Alex Ferrer. Ferrer referred to Boise and his lawsuit as “the canary in the coal mine” in the fight again opioid addiction.
What is Actiq?
Actiq (fentanyl citrate) is an opioid pain medication approved by the FDA to treat pain experienced by cancer patients. It is not intended for treating any other type of pain, including post-surgical and migraine pain.
Doctors sometimes prescribe medications for off-label use – a legal action – but pharmaceutical companies are not permitted to market the drugs or encourage these actions. Doing so is illegal.
Boise claims he decided to report Cephalon’s actions to authorities before he was aware of the False Claims Act and the protection he would receive because of it. He hadn’t even hired a lawyer when he contacted the US Food and Drug Administration and filed his report. He claimed that his employer had conducted improper sales and marketing of Actiq, as well as other medications.
After his report, Boise was asked to wear an FBI wire and assist the agency in gathering evidence that he collected at a sales conference hosted by Cephalon.
Cephalon became aware that Boise was a whistleblower and terminated his position, despite his impressive sales record. The company blackballed him and he was unable to find another position in the pharmaceutical industry. This led to the loss of his healthcare coverage and ultimately, his home.
Realizing he had no prospects in the industry in which he had knowledge and experience, Boise learned about the False Claims Act and the protections and opportunities it could provide for him. He contacted an attorney and was able to file a qui tam lawsuit against Cephalon which resulted in $425 million in penalties against Cephalon. A criminal charge was also levied against the company.
Whistleblower Laws Provide Protection to People Who Report Off-Label Marketing Efforts by Drug Companies
According to whistleblower laws, those who report wrongdoing to government officials and whose report results in a penalty of $1 million or more are eligible to receive compensation for their report. They also receive protection against retaliation.
Boise and his attorneys say he is honored that his efforts were recognized and his sacrifices were acknowledged publicly. The CBS report also drew attention to the challenges whistleblowers face, as well as the role they plan in helping stop wrongdoing.
Boise’s lawsuit was not the first filed against Cephalon because of how it has marketed Actiq. In 2009, the company persuaded a judge to dismiss a lawsuit filed by a shareholder for promoting the drug as “an ER on a stick” and encouraging patients and doctors to use it for treating migraine headaches.
That lawsuit came in the years after Cephalon had acquired Actiq from Anesta, the original manufacturer, in 2000 and by 2002 had increased Actiq sales by 92 percent.
A class-action lawsuit was filed against the company in 2013 for related issues.
People who have information about wrongdoing concerning pharmaceutical sales and marketing or other products are encouraged to reach out to government authorities and report what they know. Doing so could make them eligible for legal protection and financial compensation.