Assertio Therapeutics, Inc., the pharmaceutical manufacturer previously known as Depomed, Inc., has agreed to a $3.6 million settlement over claims it violated the False Claims Act. Announced by the Justice Department on May 5, the company faced allegations of causing the submission of false claims tied to its marketing of the fentanyl product Lazanda. The settlement also resolves a whistleblower lawsuit, further detailing the company's dealings with prescribing practices relevant to high-volume prescribers of transmucosal immediate-release fentanyl (TIRF).
According to a press release by the U.S. Attorney's Office for the District of Columbia, the company directed its marketing towards pain specialists who prescribed significant amounts of TIRF drugs. Some of these are even after being flagged for diversion or following indictments. The marketing approach included allegedly placing these high-prescribing individuals onto its speakers’ bureau and advisory boards, and implementing a "Signature Support Program" tailored to ensure that insurance plans, including Medicare Part D, would cover Lazanda prescriptions.
The allegations brought forward claim that Assertio's marketing tactics resulted in prescriptions written for beneficiaries of Medicare and TRICARE, who did not require the drug, as it was approved by the FDA solely for breakthrough cancer pain in patients who were already on an opioid regimen for persistent cancer pain. "This company took steps to boost its profits...
Assertio Therapeutics, Inc., the pharmaceutical manufacturer previously known as Depomed, Inc., has agreed to a $3.6 million settlement over claims it violated the False Claims Act. Announced by t...