RPT-Under Pressure, FDA To Hold Public Meeting On Off-Label Use

The U.S. Food and Drug Administration will hold a public meeting this summer to address drug company concern that restrictions on what they can say about off-label use of drugs violate their First Amendment right to free speech.

The meeting, announced last month by FDA chief counsel Elizabeth Dickinson, comes as a bill known as 21st Century Cures, designed to speed new drugs to market, is moving through Congress. Language in the bill is adding pressure on the agency to relax its guidelines.

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