Galena Biopharma Inc., was ordered to pay more than $7.55 million to resolve allegations that it paid kickbacks to doctors to prescribe its potent fentanyl-based drug Abstral, the Department of Justice (DOJ) announced.
Abstral is a powerful opioid that is only approved for breakthrough pain in cancer patients 18 years of age and older who are already tolerant to opioid therapy for their underlying persistent cancer pain. It is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death can result at any dose in patients not on a chronic regimen of opioids. For this reason, Abstral is not to be used for the management of acute or postoperative pain, including headaches/migraines, dental pain or use in the emergency room.
However, the DOJ charged that Galena paid kickbacks on many levels to induce doctors to prescribe Abstral, including providing dozens of free meals to doctors and staff from one high-prescribing practice; paying doctors $5,000 and speakers $6,000 plus expenses to attend so-called advisory board meetings for drug reps; and paying $92,000 to a physician-owned pharmacy under a performance-based rebate agreement to encourage the pharmacy owners to prescribe the opioid.
Two of the doctors who received payment from Galena were tried, convicted and later sentenced to prison in the U.S. District Court for the Southern District of Alabama.
“Given the dangers associated with opioids such as Abstral, it is imperative that prescriptions be based on a patient’s medical need rather than a doctor’s financial interests,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice intends to vigorously pursue those who offer and receive illegal inducements that undermine the integrity of government health care programs.”
“The conduct alleged by the government and resolved by today’s settlement was egregious because it incentivized doctors to over-prescribe highly addictive opioids,” said Acting U.S. Attorney William E. Fitzpatrick for the District of New Jersey. “This settlement constitutes another example of the Department of Justice’s ongoing efforts to battle the opioid epidemic on every front.”
The settlement is a coordinated effort by the Civil Division’s Commercial Litigation Branch and the U.S. Attorne’s Office for the District of New Jersey, with assistance from the Department of Health and Human Services Office of Counsel to the Inspector General, and the Food and Drug Administration Office of Criminal Investigations’ New York Field Office.
Galena has not marketed any pharmaceutical product since late 2015.
Source: Department of Justice