Gottlieb Likely to Take On Off-Label, Predictability at the FDA

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Dr. Scott Gottlieb is the right man in the right place at the right time. The man who will shortly assume the FDA commissionership knows the people, the process, and the pressure points. In short, he'll be further along the learning curve than anyone ever tapped for the nation's number-one public health regulatory slot. And that's important, because time is short and the needs are great.

What can we expect from a Gottlieb-led FDA? First, we'll see less mission creep. Career regulators at the FDA love ambiguity because it gives them almost unlimited authority. Gottlieb knows that it's the predictability of the process, not speed, that is most important to the industries FDA regulates. Predictability enhances confidence in the system, which, in turn, leads to greater willingness to invest in new and more difficult development programs. And that's as true for new medicines for Alzheimer's disease as it is for generics, biosimilars, and medical devices. We can also expect Gottlieb to encourage more creative use of data and analytics.

We're also likely to see guidance on the sharing of truthful off-label information.  While the FDA must continue developing specific labeling for the medicines it approves, it mustn't stand in the way of knowledge gained via real-world therapeutic experience. The FDA doesn't regulate the practice of medicine and, according to more than one recent court decision, cannot stand in the way of sharing important medical data. Gottlieb can put the FDA on the right side of history.

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