FDA releases draft guidance on off-label communications.


The U.S. Food and Drug Administration has issued the highly anticipated draft guidance to drug makers on how they may communicate with physicians about off-label use of products.

The guidance offers a number of ways that manufacturers can share truthful and non-misleading information-and still meet the FDA’s definition of being consistent with a brand’s FDA approved labeling.

Examples include:

  •             How a product performs in specific sub-groups within it’s approved patient population
  •             Data about long term safety and efficacy of products treating a chronic condition
  •             Updates from head to head trials with drugs for the same indication and
  •             Providing additional context about a drug’s mechanism of action

The pharma industry has been seeking clarification about off-label communications for some time. The FDA held a two day hearing in November of 2016 during which drug makers and others argued for sharing off label information with providers and payers.

The guidance is open for public comment for the next 90 days.

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