FDA Enforcement Inflation: What’s Next?

I grew up in a home where just a cast of my mother’s glance was enough to cause me to stop dead in my tracks. I knew “the look” quite well. There were no raised voices.

When a parent doesn’t follow through on the gentlest of correction, then the parent is communicating that an appropriate response is optional. Out of frustration, parents often up the ante by resorting to yelling and making idle threats. Nothing really changes, because nothing has to. There is more yelling than consequences.

Such has been the history of FDA regulatory enforcement. The threats had to escalate. Their voice had to get louder. The stakes had to get bigger to get industry attention.

I remember the day (now I sound really old) when an FDA483 caused you to clutch your chest and wonder whether your career was over. Over time the FDA483 just became a “calling card” as we used to call it. It was just evidence that the FDA paid a site visit. “It’s just a short one,” we’d say. “No biggie.”

Then Warning Letters became more prolific because FDA483s just didn’t get sustained compliance. “Everyone takes their turn in the barrel,” we’d say. “It was just our turn.”

Then the yelling started.

Eli Lilly (1989), Warner Lambert Consent Decree (1993) and American Red Cross (1993) ushered in a new era and a new FDA enforcement lever. There are now over sixteen major Consent Decrees, not counting those from the swath cut through the medical gas industry in early 2000.

Rather than the “pay-as-you-go” investments in improving the manufacturing operations and ensuring the state of control, some apparently have chosen profits over control until one day all goes wobbly and the FDA finally blows its stack. Even so, a fine of multi-millions of dollars is a drop in the bucket to the company. (The cost, of course, is passed on to patients.) “A blip in the stock price. A one-time hit,” we’d say.

But last week things started getting personal, and the FDA is threatening to up the ante again. Now mom is throwing the china to get attention.

Although the Parke Doctrine had been at the FDA’s disposal since 1975, apparently it is being dusted off because, well—it has to be.

The Parke Doctrine is all about personal accountability. Individuals—not corporations—are personally charged with a crime. Their careers are over, and a criminal record taints them for life. (See The QA Pharm 9/11/10.)

Unfortunately, this just might be what it takes for the management at some companies to take their personal role seriously in assuring that they are in compliance with FDA regulations enacted to ensure public safety.

Thankfully, not all pharmaceutical companies are recidivists. Hopefully, reading the trade news about Consent Decrees will not become passé.

Threat of personal prosecution needs to grab industry attention—like Consent Decrees, ah…like Warning Letters, um…like FDA483s used to.