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

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.

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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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He also recognizes the power of intramural opportunities. Not everything regulatory needs to evolve exclusively inside the hallowed walls of White Oak. Case in point — biomarker validation. Under Gottlieb, more pragmatic partnerships with industry and academia can lead to substantially accelerated FDA reviews and decision-making by allowing FDA staff to focus on their primary role of product review and regulatory oversight.

For those who think he's “too close to industry,” remember that FDA must be regulator of and ally with industry. Scott is the perfect guy to practice that nuanced relationship. Most importantly, he understands whom the FDA serves. Scott Gottlieb will be the patients' Commissioner.


Peter Pitts is president of the Center for Medicine in the Public Interest. During his time as an FDA associate commissioner, he worked with Gottlieb.