March 15, 2021 – The FDA Office of Prescription Drug Promotion (OPDP) marked the 10-year anniversary of the Bad Ad Program in 2020, and kicks off 2021 with three enforcement actions – two Warning Letters and one Untitled Letter – two of which cited the Bad Ad Program as the source of complaints about potentially […]
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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 […]
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Dec. 20, 2019 – As 2019 comes to an end, the FDA’s Office of Prescription Drug Promotion issued its third Warning Letter of the year to Alkermes Inc. for a medication-assisted treatment drug print ad for Vivitrol® and followed that up with an unprecedented press release about the enforcement action on Dec. 11. OPDP also […]
Read more Oct. 3, 2016 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has issued just four enforcement letters in 2016, it remains focused on enforcement through other means, such as issuing guidance documents, and reviewing draft product labeling and launch materials to promote voluntary compliance, according to OPDP Director Tom Abrams. Abrams, who spoke […]
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