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

FDA sign
Pharma has asked the FDA to allow it to share off-label data with payers, if not doctors and consumers.

Now that pharma has prevailed in free-speech legal battles concerning off-label marketing, it’s pushing the FDA to relax its regulations—and drugmakers 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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Payers “play such a gatekeeping role with respect to patients,” Kellie Combs, an attorney for Ropes & Gray who testified at the hearing on behalf of the Medical Information Working Group, told Medical Marketing & Media. “There's a real interest in getting information to payers as soon as possible.”

That role has been growing over the past few years as payers fight high drug costs with more aggressive formulary management tactics. As meds battle their in-class rivals to keep prime positioning, it's in their makers’ best interests to have any positive data—even data that’s not yet part of their FDA-approved labels—in the hands of the decision-makers.

The industry owes tiny Amarin for the ability to push its new off-label marketing agenda. In March, the drugmaker extracted a settlement from regulators that granted it power to push its fish-oil med Vascepa for unapproved uses, provided it dropped its free-speech lawsuit against the FDA.

Now, the agency is dealing with industrywide repercussions, and following the hearing, it’ll weigh whether or not to issue new guidance. On that front, a spokeswoman for the agency told MM&M that it intends to provide it “as needed after the meeting.”

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