- Federal officials have launched new investigations into Johnson & Johnson in recent months, attempting to better understand the large drugmaker's practices regarding marketing, charitable contributions and product information.
- The probes came to light in the company's first quarter financial filing with the Securities and Exchange Commission, which revealed that the U.S. Department of Justice (DOJ) and the U.S. Attorney's Office for the District of Massachusetts have issued two civil investigative demands (CIDs) and two subpoenas to Johnson & Johnson since January.
- Law enforcement agencies dole out CIDs when there is suspicion that an individual or business may be committing fraudulent actions. In this case, the DOJ is requesting information about sales and marketing tactics for the hepatitis C drug Olysio (simeprevir), as well as management and advisory services for rheumatoid arthritis treatments Remicade (infliximab) and Simponi Aria (golimumab).
Johnson & Johnson received the CID for Olysio in January and the one for Remicade and Simponi Aria in March. Sprinkled alongside them in February and April were two subpoenas from the U.S. Attorney's Office for the District of Massachusetts.
According to the filing, the February subpoena requested documents detailing the drugmaker's relationship with non-profits that give financial help to Medicare recipients. In particular, officials want to know when Johnson & Johnson gave those organizations money.
Such requests have become commonplace over the last couple years. Pfizer, Jazz and Biogen are just a few examples of companies pressed for information about their workings with patient assistance providers.
On a separate topic, the April subpoena asked for records "broadly relating" to co-pay programs for Crohn's disease therapy Stelara (ustekinumab), Olysio and Simponi.
Johnson & Johnson didn't provide additional information in the filing, nor did they respond to request for comment.
More investigations, however, are rarely good news. While the company is no stranger to dealing with state and federal law enforcement — the U.S. Attorney's Office for the Southern District of New York issued a CID in March 2016 targeting Johnson & Johnson contracts with pharmacy benefit managers, for example — these newest probes could harm some of its mega-profitable drugs.
Remicade, Simponi and Stelara comprise almost all of the drugmaker's immunology portfolio, and brought in nearly $3 billion in revenue during the first quarter.