A Consent Decree takes a tremendous toll on an organization, with a typical decree lasting between 5 to 7 years, and aggregated costs amounting to more than $500 million in fines, penalties, remediation expenses and lost sales. In addition to its major economic impact, consent decrees can severely damage a company’s reputation with both its customer base and patients.
By the time a consent decree is in effect, it’s no longer a discussion about responses to Form 483 observations with well-turned promises, but rather a mandatory and complete makeover to the organization’s Quality System. For the organization, the pronouncement that it somehow now knows the entirety of the problem with it’s“now, I got it” approach, exposes the ruptured foundation of its current quality system.
This is because the end goal of a consent decree is for the organization to demonstrate sustainability of its quality system, and that will take considerably more to prove than a fresh coat of paint.
Regardless of the huge effort, time and expense to redesign and implement a more robust Quality System (QS), the real test becomes“How sustainable will the redesigned QS be?“
Long after the remediation consultants have gone, the project plans have been flawlessly executed, and the senior management dashboards fade away, the real test is yet to come—sustainability.
“Sustainability” is an elusive attribute that is difficult to achieve under normal circumstances, let alone under the supervision of the Department of Justice.
Sustainability is the capability of an organization to understand when it is steering off-course –how to make the right decision and take the right actions to keep itself on the track of compliance without external intervention. In other words, maintaining a state of control based on your own capability.
Sustainability embraces aspects such as organizational values, culture, empowerment and accountability. These terms are not requirements in the 21 CFR, but the demands of sustainability require nothing less than organizational transformation: from something, to something else that wasn’t there before—a complete overhaul.
A Consent Decree is no longer about having the FDA reminding your organization over-and-over again about the same problems. Today, consent decrees mandate a series of annual inspections be performed by a third-party to determine sustainability, and they report the outcome to FDA, absolving the FDA from having to do it.
Therefore, the FDA has already predetermined the decline of the defendant, and they now look for the third-party to spend their time (and the defendant’s money) to inspect and certify compliance—often for many years—measuring sustainability.
I know it is not easy to achieve the attribute of “sustainability”, but it is always worth pursuing under normal circumstances. So, why wait for an injunction?
Consent decrees require an entirely different kind of response than usual, because they elicit a different kind of result than usual —sustainability.
What do you think is the most significant factor that causes a Consent Decree?
