A recent inspection report from the U.S. Food and Drug Administration (FDA) revealed that AbbVie failed to properly investigate deaths that were reported in connection with three of its medications. The FDA faulted the company for not requiring employees to collect and test complaint samples, a significant failure of the quality-control process.
The drugs in question were all produced at AbbVie’s North Chicago manufacturing facility and include venetoclax (used to treat chronic lymphocytic leukemia), adalimumab (used to treat rheumatoid arthritis), and leuprorelin (used to treat endometriosis and uterine fibroids). Adalimumab is a blockbuster drug for the company, generating 65 percent of its revenue.
An AbbVie spokeswoman stated that the company was responding appropriately to the report. “AbbVie takes complaint handling very seriously and is dedicated to fully investigating and resolving all complaints,” she said. “Written complaint procedures are in place to investigate, analyze, and resolve complaints.”
The FDA issues many such reports each year, though most involve quality-control issues in drugs from India and China. According to John English, a manufacturing validation consultant, this rebuke is unusual for another reason as well: “This is one of the few times I can recall where ‘death’ was identified as a flag that was ignored.”
Source: STAT News, June 8, 2018.