It appears the Biden administration is having difficulty with selecting a new Commissioner of Food and Drugs (FDA Commissioner). (FiercePharma Story NBC News Story Endpoint News Story) I was thinking about why this is, given it’s such a powerful and important role. It dawned on me how similar being the FDA Commissioner is to being a Chief Quality Officer (CQO) or head of quality within an FDA-regulated life science company.
Both these roles are — to a large extent — no-win roles. You’re damned if you do and damned if you don’t. For example, with the FDA Commissioner’s role, you’re damned if you work hard with industry to try and create opportunities for improved market entry for innovative products or, by working on international regulatory harmonization. By doing these types of “industry-friendly” activities, you’re seen as being in bed with industry. If on the other hand, you take an aggressive posture towards public safety you’re seen as an over-reaching regulator, out of touch with the needs of business and industry. If you navigate the middle ground — trying to foster innovation and harmonization while being strong on rogue and uncaring companies — you’re attacked by both sides.
This has significant parallels to the often-impossible challenges heads of quality experience. Often CQOs or other senior quality executives are characterized by Operations or Finance as not business-supportive or not “understanding” the business. For those that get beaten down by these assertions and start playing the game — reducing headcount a little here, and not investing in their operations a little there — the eventual chipping away at robust systems and controls often ends in failure.
These failures – such as a product recall, a critical product launch failure – or worse, a warning letter or consent decree – often result in immense costs to the company. Senior management then hypocritically asks CQOs “how did this happen? How did this failure occur on your watch?” This reminds me of Capt. Renault’s famous line from Casablanca, “I’m shocked, shocked to find that gambling is going on in here!”
I hope the Biden Administration finds the rare individual who can confidently navigate this difficult balance of exceptionally difficult competing perspectives on FDA’s mission. Like great heads of quality, great Commissioners of Food and Drugs are hard to find. You need thick skin, exceptional experience and skills, the wisdom of Solomon and the political savvy of Machiavelli. To quote Pink Floyd, “is there anybody out there….”
