FDA Sends Violation Letters to Biogen, Gilead, Aton Over Rx Drug Promotions

The Food and Drug Administration April 7 released violation letters that it sent to Biogen Idec, Gilead Sciences, and Aton Pharma over promotional materials for three prescription drugs.

The agency’s Division of Drug Marketing, Advertising, and Communications sent so-called untitled letters to Biogen Idec regarding a promotional webcast for Tysabri (natalizumab), to Gilead for a print advertisement for Truvada (emtricitabine and tenofovir disoproxil fumarate), and to Aton Pharma for a flash card on Mephyton (phytonadione) Vitamin K1. An untitled letter cites violations that do not meet the threshold of regulatory significance for an FDA warning letter, according to the agency’s ...