FDA Delays Off-Label Rule Opposed By Big Pharma

Law360, New York (March 17, 2017, 7:42 PM EDT) -- Bowing to pressure from Big Pharma, the U.S. Food and Drug Administration on Friday delayed by one year a controversial new rule that endorsed a broad approach to determining whether drug and device makers are engaged in off-label promotion.

The delay to March 19, 2018 came in response to a citizen petition filed last month by Pharmaceutical Research and Manufacturers of America, the Biotechnology Innovation Organization and a drugmaker coalition called the Medical Information Working Group. The petition, which sought a stay and reconsideration, strongly criticized a final rule related to “intended use” — a concept that looks at whether manufacturers...

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