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US FDA Hears Competing Messages On Off-Label Communications

 
• By Elizabeth Orr, Sue Sutter, and Derrick Gingery

Over the course of a two-day meeting at FDA headquarters, the agency heard from the medtech industry, which argued for expanding rights to off-label promotion, and consumer groups that worry about the possible impact on the public health. The meeting is intended to inform FDA's comprehensive review of its regulations and policies governing firms' communications about unapproved uses of approved/cleared products.

As FDA continues its wholesale review of policies governing off-label communications by device and drug companies, the agency got an earful on both sides of the issue at two-day public hearing held at its headquarters. At the Nov. 9-10 gathering, manufacturers asked for much more freedom to disseminate off-label information while patients and patient advocates expressed concern the move could endanger the public health.

The meeting took place in the context of a string of court decisions that have pushed back on FDA's interpretation...

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