Bausch Health is back in hot water, this time because the Department of Justice (DOJ) is reportedly investigating its marketing of four drugs.
The Department of Justice has had an eye on the company since at least last year, when Bausch’s legal team received a civil investigative demand in connection with the four drugs, Stat reports. The probe centers on plaque psoriasis drugs Bryhali, Siliq and Duobrii plus fungal treatment Jublia, the publication reports.
In response, Bausch's legal team in June 2021 sent a "legal hold" to certain employees, ordering them to preserve information, documents and communications related to the medicines, Stat reports.
Specifically, the DOJ is seeking any documents related to potential promotion of Siliq for unapproved uses, communications regarding the sales and marketing of the 8-ml dose of Jublia and the promotion of Bryhali as a new class of steroid, according to the report.
The DOJ also expressed interest in information regarding financial assistance to Medicare patients for Siliq and the drug’s REMS program, which manages the risks of suicidal behavior in patients using the drug, Stat reports. Further, the DOJ is interested in possible payments to health care providers by the company.
Despite Bausch submitting its annual Securities and Exchange Commission report Feb. 23, the investigation was not disclosed in the company’s filing.
A company representative did not respond to a request for comment on the Stat report.
The news comes just weeks after the FDA found that Bausch's promotional material for Duobrii does not accurately represent the risks associated with the drug. The Office of Prescription Drug Promotion expressed similar concerns about the drug's promotion in February 2020, according to the FDA filing.
Bausch, formerly known as Valeant, changed its name in 2018 following a series of controversies related to drug pricing and accounting practices.