FDA's Off-Label Delay Not Enough For Big Drugmakers

Law360 (February 7, 2018, 8:26 PM EST) -- The U.S. Food and Drug Administration's delay of controversial new policies on off-label promotion doesn't go far enough and should be followed by quick action to erase uncertainty about acceptable marketing practices, major drugmakers said in letters released late Tuesday.

The letters, posted after a comment deadline this week, relate to the FDA's move last month to indefinitely delay a final rule with new off-label policies. The policies outlined how regulators will assess the "intended use" of drugs and devices — including whether products are intentionally being promoted for unapproved uses.

The controversy centers on the FDA's plan to examine "the...

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