Commercial Speech Issues Remain After FDA Guidance

Law360, New York (April 1, 2014, 5:13 PM EDT) -- In the last several years, drug and device manufacturers have pressed the U.S. Food and Drug Administration to clarify certain practices a manufacturer should follow when distributing truthful, nonmisleading scientific publications to health care professionals that may include information on unapproved new uses (i.e., “off-label uses”) for an approved or cleared product. More recently, a number of manufacturers, in light of three high-profile court decisions that raise questions about the FDA’s constitutional and statutory authority to regulate such manufacturer speech, have called upon the agency to...
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