FDA Marketing Rules Stretch To Drugmakers' Media Pitches

Law360, New York (November 13, 2012, 10:21 PM EST) -- The U.S. Food and Drug Administration recently scolded Cornerstone Therapeutics Inc. for failing to include information about a drug's risks in a letter seeking publicity from media outlets, an unusual warning that shows the agency considers all promotional materials, not just those directed to the public, to be under its purview.

In a letter dated Oct. 31, the FDA's Office of Prescription Drug Promotion told Cornerstone that a pitch letter and press release sent out by the company's public relations firm were false and misleading. The...
To view the full article, register now.