Increasingly, federal investigators
have been turning their attention to manufacturing deficiencies at some of the
world’s largest drug makers. According to one industry
report, the number of FDA inspection reports has skyrocketed to an all-time
high. This focused attention comes on the heels of a report from the US General Accountability
Office, which found that the FDA failed to adequately inspect a number of
manufacturing facilities around the globe.
The added governmental exposure has
shed the light on a number of problems, likely encouraging a weekly parade of
drug recalls from pharmaceutical companies. For some companies, they have led
the parade of FDA warnings and recalls on a number of occasions. For example,
Johnson & Johnson has repeatedly tangled with the FDA, most recently when
it was warned by the FDA about problems at its Cordis stent
facility. Last year, this same company temporarily closed a large Pennsylvania
facility and recalled an estimated 136 million bottles of
liquid children’s Tylenol and other pediatric products, after quality controls
failed.
However, the real driving force behind
this surge of pharmaceutical mea
culpas probably has
less to do with federal investigators and more to do with pharmaceutical
industry’s concerns about potential False Claims Act qui tam actions. The simple fact is
that drug makers are now on notice that employees can bring successful whistle-blower
suits involving current Good
Manufacturing Practices (cGMP) violations.
The extended reach of whistle-blowers
was made crystal clear last year, when the U.S. Department of Justice joined in
a whistle-blower action against GlaxoSmithKline, exposing systemic
manufacturing deficiencies at the company’s Puerto Rico facility. Ultimately,
the company settled the action for $750 million, and the whistle-blower was handsomely rewarded to the tune of
$96 million.
In a very real sense, the
GlaxoSmithKline settlement has encouraged other potential whistle-blowers to
step forward and uncover other instances of cGMP violations. More importantly,
because the False Claims Act provides incentives and protections for these whistle-blowers,
drug companies cannot simply disregard their concerns. The lasting impact is
that, whether through recalls or False Claims Act settlements, drug companies
are forced to fess up to unsafe manufacturing practices.
1.
Explain
the role of Whistle-blowers in Pharma Industry
2.
How
to identify unsafe manufacturing practices and how to solve it.
(http://pharmaceutical-kickbacks.com/uncovering-pharmaceutical-manufacturing-problems/)
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