Oct. 19, 2018 — The FDA’s Office of Prescription Drug Promotion (OPDP) issued two enforcement actions in less than a week that focused on alleged safety and risk information infractions for products with Boxed Warnings; both matters were brought to the agency’s attention through OPDP’s Bad Ad program. “These letters are significant not because they […]
Read moreMay 18, 2017 – At this week’s information-packed Coalition for Healthcare Communication’s Rising Leaders Conference, keynote speaker and former FDA Commissioner Robert Califf said that “healthcare marketers need to create a code of ethics to promote drugs for truthful and non-misleading uses outside their FDA-approved labels, commonly referred to as off-label promotion,” according to coverage […]
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Feb. 24, 2017 – The FDA recently published a final rule on intended use and adequate directions for use that establishes a not-previously-announced “totality of the evidence” standard and is in violation of the Administrative Procedures Act because it deprives stakeholders of fair notice and the opportunity to comment, according to a Feb. 8 […]
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