Drug makers to FDA: Let us share off-label study data with payers

Fierce Pharma

16 November 2016 - Now that pharma has prevailed in free-speech legal battles concerning off-label marketing, it’s pushing the FDA to relax its regulations—and drug makers believe the first step should involve sharing info with payers.

At a two-day public hearing last week, drugmakers told the agency it should allow them to share off-label data with payers, in a move that could further diminish doctors' power over which drugs their patients use.

In fact, industry reps agreed with pharma-watchers' worries about supplying off-label info to consumers and doctors, who might not understand or have time to evaluate its limitations.

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Michael Wonder

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Michael Wonder

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Decision making , Data