“Promotional materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials,” the letter states.
The issue involves Fenwal’s distributed promotional material for InterSol, an isotonic solution. The information cautions against intravenous infuse, reuse of the product and use of cloudy solution, but none of these issues were mentioned in presentation slides intended for blood bank staffers.
An FDA warning letter from 2012 scolded Fenwal for similar actions, saying its slides and brochure for InterSol “fail to provide any risk information pertaining to the use of InterSol, including the warning, precautions and the risk due to direct infusion.”
The FDA informed Fenwal that it must provide in writing steps it has taken and will take to prevent this violation from occurring again. Meanwhile, a spokesman for Fresenius told Law360 that the company is taking the matter “very seriously,” and that they “have discontinued and have withdrawn the presentation from any further use.”
The warning letter concluded by informing Fenwal that failure to correct the violations may result in FDA regulatory action, including seizure or injunction, without further notice.