FDA's Challenge To Implied Outcomes Of ADHD Drugs

Law360, New York (October 2, 2008, 12:00 AM EDT) -- In Warning Letters to two companies, and in Untitled Letters to three, the U.S. Food and Drug Administration’s (FDA’s) Division of Drug Marketing, Advertising, and Communications (DDMAC) on Sep. 25, 2008, alleged that promotional material for certain products intended for use in treating attention deficit hyperactivity disorder (ADHD) made implied claims about an effect on ADHD “outcomes” that were not supported by “substantial evidence,” as that latter term is used in statutory parlance.

DDMAC’s interpretation of the promotional material as making implied ADHD outcomes claims that...
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