Nov. 2, 2020 – After 27 years with the Office of Prescription Drug Promotion (OPDP) – formerly called the Division of Drug Marketing, Advertising, and Communication (DDMAC) – OPDP Director Tom Abrams retired from the agency on Oct. 23 as the primary force behind today’s regulation of prescription drug advertising and promotion. Abrams’ leadership shaped […]
Read moreMarch 12, 2015 – The FDA’s Office of Prescription Drug Promotion (OPDP) has issued fewer enforcement letters in recent years, decreasing from 21 Untitled Letters and three Warning Letters in 2013 to nine Untitled Letters and one Warning Letter in 2014. So far this year, OPDP has issued three Untitled Letters which, if the current […]
Read moreFeb. 23, 2015 – Dale Cooke, owner of PhillyCooke Consulting, who spoke Feb. 18 at the Drug Information Association’s Marketing Pharmaceuticals conference, told attendees that because mobile use for health information has exploded, they should be leveraging innovative technologies to reach users where they are. To view a summary of Cooke’s presentation and read his […]
Read moreJan. 14, 2014 – The determining factor regarding whether a firm submits online prescription drug promotional material to the agency is “whether the firm or anyone acting on its behalf is influencing or controlling the product promotional activity or communication in whole or part,” according to a recent FDA Draft Guidance, “Fulfilling Regulatory Requirements for […]
Read moreNov. 25, 2013 – The FDA published a Federal Register notice (2013-27770 (1)) on Nov. 20 regarding the availability of new draft guidance on product name placement, size and prominence in advertising and promotional labeling. Dale Cooke, Vice President of Regulatory Review at Digitas Health, sat down with the Coalition for Healthcare Communication to talk […]
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