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...
To view the full article, register now.