Ruling won't slow down off-label prosecutions of drugmakers

01/7/2013 | Forbes

The Justice Department's off-label investigations and pending settlements shouldn't be hampered by a recent U.S. Court of Appeals decision that some interpreted as protecting drugmakers from liability for off-label marketing of prescription drugs, lawyer Erika Kelton writes. The vocabulary used in describing violations will be different in future cases, putting emphasis on the terms "misbranding" and "intended use" more than "off-label" and "promotion." First Amendment rights aren't threatened by off-label cases that target misleading or false representations about the efficacy and safety of treatments, Kelton writes.

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