Recently, the United States Department of Justice (DOJ) announced a $750,000 settlement with Sentynl Therapeutics, Inc., of Solana Beach, California, to resolve allegations that the company violated the False Claims Act by causing the submission of claims for certain opioids in violation of the federal Anti-Kickback Statute.
According to the settlement, from December 1, 2015, through August 31, 2016, Sentynl marketed and sold prescription substances Abstral and Levorphanol Tartrate (“Levorphanol”). Abstral is a Transmucosal Immediate-Release Fentanyl (TIRF) medication designed to administer an immediate dose of fentanyl in sublingual tablet form. It is approved by the Food and Drug Administration (FDA) for the treatment of breakthrough pain in opioid-tolerant cancer patients and is a Schedule II narcotic under the Controlled Substances Act. Levorphanol is a controlled substance tablet approved by the FDA for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are not adequate. It is also a Schedule II narcotic under the Controlled Substances Act.
The United States alleges that during the aforementioned time period, Sentynl knowingly caused the submission of claims for both Abstral and Levorphanol to Medicare in violation of the Anti-Kickback Statute, resulting from remuneration Sentynl provided to a physician and the physician’s girlfriend in South Florida. The United States further alleges that the physician was a top prescriber of TIRF medications and Sentynl hired the physician’s girlfriend to act as a sales representative in South Florida – the same region in which the physician practiced. Sentynl hired, employed, and made salary and bonus payments to the girlfriend to induce the physician to prescribe Abstral and Levorphanol.
As is often the case in similar settlements, it does not include an admission of wrongdoing by Sentynl, and in fact, it includes a statement that Sentynl denies the allegations. The settlement also notes that Sentynl “agrees to cooperate fully and truthfully with the United States investigation of individuals and entities not released in this Agreement.”
While this settlement is not one of the largest in terms of dollars, it does raise questions about the diligence that pharmaceutical companies are expected to perform to understand the relationship between their employees and potential customers.
“Some violations of the Anti-Kickback Statute, like those alleged here, can induce physicians’ imprudent prescribing of controlled substances,” said Special Agent in Charge Naomi Gruchacz with the U.S. Department of Health and Human Services Office of Inspector General. “Individuals and entities that participate in the federal health care system are required to obey the laws meant to preserve the integrity of program funds and the provision of appropriate, quality services to patients.”
In a statement about the settlement, Sentynl “strongly” denied the DOJ allegations and noted that “after spending more than five years cooperating with the government investigation, we made the practical decision to resolve the matter with a settlement that includes a nominal payment and no acknowledgment of wrongdoing.” The statement went on to say, “When we first learned that an employee had a potential conflict of interest — years before the government became involved — we immediately launched an investigation and terminated the employee at the end of the review. We’re confident that the company acted appropriately and are pleased to have this matter fully resolved. We look forward to focusing our full attention on advancing our therapeutics focused on rare disease patients.”