[This article originally appeared on CafePharma, written by Joseph Gentile.]
Earlier this year, the Department of Justice (DOJ) announced a new initiative to fight the opioid epidemic ravaging the nation – the creation of the Prescription Interdiction and Litigation (PIL) Task Force. The initiative targets unscrupulous painkiller manufacturers and distributors who overprescribe and allow the misuse and diversion of prescription painkillers. Through this and other measure, the DOJ has made it clear that it has made opioid related cases and investigations a priority issue.
The DOJ promised to use the False Claims Act and whistleblower information as a primary tool to fight the epidemic. The qui tam provisions of the False Claims Act allow private citizen whistleblowers to file lawsuits on behalf of the United States when they believe that a party has submitted false claims for government funds. If the government obtains money as a result of the suit, the whistleblower may receive between 15% and 30% of the government’s recovery. Company insiders make the best whistleblowers because they have access to internal non-public information.
The DOJ is now following through on its promise. According to a May 15, 2018, press release by the DOJ, the United States recently agreed to join five cases that were filed by whistleblowers who accused Insys Therapeutics Inc., of illegally marketing the opioid painkiller Subsys. Insys manufactures Subsys which is a sublingual spray form of fentanyl, a powerful, but highly addictive, opioid painkiller.
As alleged in the DOJ’s complaint, Insys paid kickbacks to induce physicians and nurse practitioners to prescribe Subsys for their patients. These kickbacks included: speaker program payments for speeches to physicians that were, in fact, shams; jobs for the prescribers’ relatives and friends; and, lavish meals and entertainment. The United States also alleged that Insys improperly encouraged physicians to prescribe Subsys for patients who did not have cancer, and that Insys employees lied to insurers about patients’ diagnoses in order to obtain reimbursement for Subsys prescriptions that had been written for Medicare and TRICARE beneficiaries.
Given the public outcry and the level of resources the government has committed to fighting this crisis, we expect many more prosecutions. Pharma employees will play a large role, as they are eye-witnesses to the conduct of manufacturers and prescribers. Offering kickbacks, misbranding or promoting drugs in an off-label manner or with an intent to encourage diversion or non-medical uses, are all illegal. The government has indicated a desire to prosecute these violations, recoup government funds and secure the public health. Blowing the whistle on this conduct can be financially rewarding, saves tax dollars and protects people’s lives.
