Whichever party wins in November, one truth will prevail at FDA – regulators love ambiguity but can learn to embrace predictability. A second truth is that FDA decisions are and will continue to be based solely on sound science and its impact on the public health. So, whether red or blue is ascendant, FDA will rule on silicone breast implants and OTC “Plan B” based on the facts.

What might change, depending on who occupies the Oval Office and the Commissioner’s Office, is how the FDA views the concept of time. And it could go either way.

There is real time and there’s FDA time. There’s an old Washington story that says Henry Kissinger once asked former Chinese leader Chou En Lai whether the French Revolution of 1789 had benefited humanity, Chou responded: "It's too early to tell." Chou would have made a great regulator. Real time is for the world we live in. The clock we watch – for business, certainly, but also for the rest of us.

FDA time is the time it takes to get it right. Barring a doubling of the FDA budget, the only real way to meaningfully accelerate FDA actions without compromising quality (read “safety and effectiveness”) is through collaboration.

Would a Kerry administration stifle collaboration with industry and outside groups? Will collaboration continue to be embraced by the next Republican Commissioner? These are the crucial questions.

FDA’s career staff has shown that it can be both regulator and colleague. But the agency is a very hierarchical organization. When the Commissioner says “collaborate,” it happens. Otherwise, it’s on FDA time.

A related core issue is predictability – the opposite of ambiguity. Predictability is power in pursuit of the public health. A case in point is FDA’s current “critical path” initiative. But ambiguity is bureaucratic power.

This election, relative to the future of the FDA, there is a battle between nascent predictability and insidious ambiguity. So, President Bush, Senator Kerry, and Mr. Nader – I worked at FDA, and I vote.