DOJ investigating Bausch Health over plaque psoriasis drug marketing — report
Just a few weeks after Bausch Health ran afoul of the FDA’s drug marketing police, a new report has emerged that the company has been under investigation by the Department of Justice since at least last June.
STAT News reported Bausch circulated documents among its legal team on June 14, 2021, outlining its strategy to comply with the DOJ’s request. The probe, known as a civil investigative demand, aims to look at whether Bausch promoted three plaque psoriasis drugs — as well as a fungal treatment — in ways not intended for use.
DOJ is also examining if financial compensation was provided to Medicare patients who had been prescribed one of the drugs, the compliance information regarding that drug and if other payments had been made to doctors helping promote all four treatments, according to the report.
Endpoints News has reached out to Bausch Health and will update accordingly. DOJ declined to comment, citing its general policy to “not confirm, deny, or otherwise comment on the existence or non-existence of investigations, criminal, civil, or otherwise.”
According to documents obtained by STAT, Bausch directed employees to preserve all documents and communications related to the four drugs: Siliq, Bryhali, Duobrii and Jublia. Most of the preservation requests stem from the company’s work around Siliq and the financial compensation provided to patients taking that drug.
Per the document, the action amounts to what’s known as a “legal hold,” instructing employees to comply until instructed otherwise. It’s not clear when DOJ first launched its investigation.
The revelation comes a couple of weeks after Bausch ran into trouble at the FDA — again. Per an untitled letter dated March 31, the FDA’s Office of Prescription Drug Promotion (OPDP) found multiple issues with Bausch’s marketing practices of Duobrii, including a “misleading” video and problematic claims about purported efficacy.
OPDP also noted this was not the first time it had taken issue with Duobrii marketing. Back in February 2020, the office “expressed similar concerns,” according to the letter.
FDA declined to elaborate on specifics when contacted by Endpoints, and Bausch, after initially saying it had not received a letter from the agency, clarified its statement that OPDP “provided non-public advisory comments in response to our preclearance submission of the video” in 2020.
Duobrii is a combination corticosteroid and retinoid cream, approved in 2019 to treat moderate-to-severe plaque psoriasis. Siliq is a monoclonal antibody OK’ed in 2017 to treat the same population.
