FDA issues updated guidance on off-label communications: 6 key notes

The FDA updated its draft guidance on its handling of off-label communication for its regulated products, Gastroenterology and Endoscopy News reports.

Here's what you should know.

1. The update seeks to allow manufacturers flexibility concerning medical claims while protecting the public from misleading or false information.

2. The agency recommends "firms accurately characterize and contextualize the relevant information about the product, including by disclosing unfavorable or inconsistent findings" and "disclose material contextual information from the FDA-required labeling in these communications, such as data and information from studies in the FDA-required labeling that are relevant to the data or information presented in the communication."

3. The update criticizes the use of marketing material unsupported by scientific evidence, saying it can create a "false or misleading impression."

4. Of the 500 firms and 162,000 promotional materials, the FDA estimates that approximately 5 percent are consistent with FDA standards. It expects that number will soon rise to 6 percent.

5. If the FDA finds the material to be misleading, firms could be subject to regulatory action.

6. The proposal is available for public comment for three months.

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