The federal Food and Drug Administration has announced closure of an investigation of Mylan's warning-bypass problem.
The FDA investigation was triggered by a Post-Gazette report that quoted an internal Mylan report as described "pervasive" and "very serious" violations of quality control procedures at Mylan's pharmaceutical manufacturing facility in West Virginia, including "falsifying information" and "altering product."
Does Robert Coury (left), Mylan CEO chairman, a man with no apparent pharmaceutical industry experience when selected by a friend to become a Mylan executive seven years ago, take a useful lesson from this episode? Sure. In fact, he takes two: This never happened and newspaper reporters are scum, especially when they do their jobs.
Coury sees this affair not as a cautionary tale -- described as "very serious" by industry experts whose paychecks are not issued by Mylan -- but instead as a reaffirmance of Mylan's "48-year exemplary record of quality."
"Mylan's manufacturing facilities -- especially our plant in Morgantown -- have always represented the gold standard when it comes to quality, Mr. Coury said, apparently using "always" to mean 'except when employees were repeatedly falsifying reports, ignoring and disabling quality-control alarms, misusing passwords and altering products.'
Mr. Coury, whose journalism cred apparently rivals his lifelong devotion to pharmaceutical quality-control standards, excoriated the P-G reporting for being based on "improperly obtained documents, uninformed third-party commentary and anonymous sources." I notice the absence of any complaint about "non-genuine" documents, "false" third-party commentary and "inaccurate" sources. Mr. Coury does not identify, let alone controvert, a single point of information he claims to have been wrongly reported by the Post-Gazette.
That's a curious focus for an executive who has just been shown that his company needs some practices-and-ethics training. Unless you figure Coury for the kind of guy who might respond to news that one of his employees has been caught inflating a resume with an uawarded (and apparently unearned) degree -- a scandal that cost the university president, who was a friend and business associate of the academically confused employee, his job -- by promoting that employee.
It's too bad pharmaceutical labeling requirements don't require a listing of the CEO whose company actually produced a generic product, because I know I'd be looking for Mr. Coury's name when deciding whether to purchase a pill.
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