Johnson & Johnson reveals investigation and subpoenas from DOJ over arthritis co-payment program

Johnson & Johnson revealed to investors on Monday its Janssen Biotech Inc. is under investigation by the United States Department of Justice regarding i a False Claims Act case about  two of its arthritis drugs, while also reporting a separate probe by the U.S. attorney’s office in Massachusetts over copayment support programs.

The company said in a 10-K filing that Janssen Biotech in March received a civil investigative demand from the DOJ over a False Claims Act investigation. The request concerned “management and advisory services provided to rheumatology and gastroenterology practices that purchased Remicade or Simponi Aria,” two biologic prescription drugs used to treat rheumatoid arthritis, among other conditions.

Remicade is one of J&J’s top-selling drugs, used to treat arthritis and a number of other immune-mediated inflammatory diseases, according to J&J. Sales of the drug in 2015 made up 9.4 percent of the company’s total annual revenue, bumping up to approximately 9.7 percent of the company’s total revenues the following year, according to the company’s 2016 annual report.

J&J received a subpoena from the U.S. Attorney for the District of Massachusetts, which  sought a range of documents broadly related to pharmaceutical copayments for Simponi, a self-injectable biologic for treating arthritis, Olysio, a treatment for hepatitis C, and Stelara, a biologic used to treat psoriasis and Crohn’s disease.

“The subpoena also seeks documents relating to average manufacturer price and best price reporting to the Centers for Medicare and Medicaid Services related to those products, as well as rebate payments to state Medicaid agencies,” the 10-K said.
“Multiple pharmaceutical companies have publicly reported receipt of similar subpoenas and ongoing inquiries,” the subpoena said.

Jeffrey Newman represents whistleblowers