The federal government has joined the whistleblower lawsuit leveled against the specialty drug maker, as INSYS puts its minimum liability exposure at $150 million.
INSYS Therapeutics, Inc. says it has become "a completely transformed organization" in the face of stinging federal allegations that it bribed clinicians to push its powerful opioid painkiller, and lied to insurers to get reimbursements.
"INSYS continues to have ongoing dialogue with the DOJ regarding this investigation," the Phoenix-based specialty drug maker said in a media release.
"Today, INSYS is a completely transformed organization, with a promising pipeline, a strong commitment to serving patients as well as an organizational culture of high ethical standards."
The statement was issued this week hours after the Department of Justice announced that it would join a whistleblower lawsuit leveled against the drug maker.
The suit, unsealed this week in a federal court in Los Angeles, alleges that INSYS paid kickbacks to physicians and nurse practitioners to get them to prescribe Subsys, a spray form of fentanyl approved by the FDA in 2012 for the treatment of persistent pain in adult cancer patients.
"Many of these kickbacks took the form of speaker program payments for speeches to physicians that were, in fact, shams; jobs for the prescribers’ relatives and friends; and lavish meals and entertainment," DOJ said in a media release.
Federal prosecutors also allege that INSYS pushed physicians to prescribe Subsys for patients who did not have cancer. In addition, INSYS employees allegedly lied to insurers about patients' diagnoses to obtain reimbursement for Subsys prescriptions that had been written for Medicare and TRICARE beneficiaries.
"Insys allegedly bribed doctors who are more concerned with profits than patients," said Christian J. Schrank, Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services.
"Encouraging the inappropriate use of this too-often deadly opioid is intolerable enough, but the abuse is compounded when taxpayers are forced to pick up the bill," Schrank said.
The whistleblower suit was filed in 2013 by former INSYS sales rep, Maria Guzman, who detailed what she said were overt and disguised bribes that INSYS made to doctors to increase prescriptions and dosages of Subsys, and lies used to rationalize the off-label benefits for patients.
"Sex, money, luxury items – nothing was out of bounds in INSYS's efforts to persuade doctors to prescribe Subsys without consideration of what was best for patients," Guzman said. "I could not keep silent, knowing how these off-label prescriptions endangered so many."
John Commins is a senior editor at HealthLeaders.