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The QA Pharm

FDA Compliance

Consent Decrees—When the FDA Gets Tired of Talking

Companies are much better off overseeing their own compliance to regulations

Published: Tuesday, March 22, 2011 - 08:08

By the time a consent decree comes along—which happens when a firm repeatedly violates current good manufacturing practice (cGMP) requirements and the Food and Drug Administration (FDA) forces it, through legal channels, to make specific changes—it’s no longer a discussion about responses to observations. It’s about a do-it-yourself renovation—a complete makeover. It’s a “gut-it” approach, as never before, which exposes the cracked foundation and termite-eaten beams weakened over time.

This is because the common element of a consent decree is demonstrating sustainability. As in “over time.” That takes more than a fresh coat of paint.

Regardless of the huge effort and expense to redesign and implement a more robust quality management system, the real test comes afterward: sustainability.

Long after the consultants have pulled up their tent stakes, with the project plans flawlessly executed and senior-management dashboards faded away, the real mettle is yet to be tested: sustainability.

“Sustainability” is an attribute that is difficult to achieve under normal circumstances, not to mention under the supervision of the Department of Justice.

Sheesh, can’t a person make an honest mistake anymore?

Is sustainability the same thing as perfection? I sure hope not. If it is, we’re all screwed.

I prefer to think about sustainability in a more realistic way. Sustainability is the capability of an organization to know when it is veering off course and to make the right decisions—to take the right actions to recenter itself without external intervention—to maintain a state of control.

As in the human body, sustainability in a company is an inherent homeostatic mechanism that monitors the manufacturing and quality process signals and responds accordingly to maintain healthy control of product quality.

Sustainability touches—nay, embraces—subjects such as values, culture, expected behaviors, empowerment, and accountability. These don’t sound much like terms in the code of federal regulations (CFR). But the demands of sustainability require nothing less than organizational transformation: from something, to something else that it wasn’t before—a makeover.

One thing for sure it is not: It’s not the FDA telling one over and over again about the same problems. In fact, consent decrees mandate a series of annual inspections performed by a third-party to determine sustainability, so the FDA doesn’t have to.

In other words, the FDA has already determined the recidivism of the defendant, so now the agency looks for a third-party to spend its time and the defendant’s money to inspect and certify compliance—often for many years—measuring sustainability. Not the FDA.

To achieve the attribute of sustainability is not easy but worth pursuing under usual circumstances. Why wait for an injunction? The often surprising benefit of the makeover is operating in the “sweet spot” of economic control of quality and providing a continuous supply of quality product.

Consent decrees require an entirely different kind of response than usual because a different kind of result than usual is expected: sustainability.

Sustainability, and the organizational capability to achieve it: That’s the goal. 


About The Author

The QA Pharm’s picture

The QA Pharm

The QA Pharm is a service of John Snyder & Co. Inc., provider of consulting services to FDA-regulated companies to build quality management systems and develop corrective actions that address regulatory compliance observations and communication strategies to protect against enforcement action. John E. Snyder worked at the lab bench, on the management board, and as an observer of the pharmaceutical industry for more than 30 years. His posts on The QA Pharm blog are straight talk about the challenges faced by company management and internal quality professionals. Synder is the author of Murder for Diversion (Jacob Blake Pharma Mystery Series Book 1).