US FDA Makes Misinformation Correction Easier For Pharma

The FDA creates a new advertising and promotion regulation safe harbor for companies who narrowly respond online to internet-based misinformation about their drugs. 

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New draft guidance okays companies skirting some FDA promotion rules to respond to online misinformation. • Source: Shutterstock

The pharmaceutical industry received narrow and unusual permission to skirt the US Food and Drug Administration’s advertising and promotion regulations to correct misinformation about their products in a new draft FDA guidance.

Key Takeaways

  • The draft guidance offers industry a way to fight online misinformation about their products without being burdened by FDA advertising and promotion regulations.

The new enforcement discretion applies only when firms use what FDA calls “tailored responsive communications,” a voluntary, internet-based communication that...

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