Why did the FDA come down so hard on Novartis?

Among the unanswered questions from last week’s Novartis data scandal is why the normally buttoned-up FDA chose to publicly castigate the company and raise the specter of civil and criminal penalties.

Writing in STAT, former FDA Commissioner Robert Califf said: “I have no special insight into the motivation for the FDA’s specific aggressive public statements regarding the [Novartis] case, but I suspect the key issue of trust in the face of overwhelming complexity is driving the stern warning and possible consequences.”

Beyond the specifics, the whole Novartis is affair is a reminder that mistakes and misdirections are fairly common when it comes to data on new medicines, according to Califf. But there's also the possibility of outright cheating. Within the industry, he writes, "complex incentives are in play."

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