Pharma Pushes to Share Off-Label Info with Payers at FDA Hearing

Friday, November 11, 2016

Source: MM&M

Drugmakers told the FDA that allowing them to share off-label information with payers would be a critical first step in redefining off-label regulations.

The FDA held a two-day public hearing this week to gather information about off-label communications, after a series of lawsuits were decided in favor of the pharmaceutical industry.

At the hearing, industry stakeholders agreed with concerns over supplying information not vetted by the FDA to consumers, who may not understand the limitations of the data, and doctors, who may not have the time in their busy days to determine what information is misleading. This leaves payers as a likely starting point for sharing off-label information.

Payers “play such a gatekeeping role with respect to patients,” said Kellie Combs, an attorney for Ropes & Gray, who testified at the hearing on behalf of the Medical Information Working Group. “There's a real interest in getting information to payers as soon as possible.”

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