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 more Aug. 30, 2018 – In its fourth enforcement letter of 2018, the FDA’s Office of Prescription Drug Promotion (OPDP) cited ASCEND Therapeutics US LLC for allegedly false claims in a sell sheet for EstroGel® 0.06%, stating that the sell sheet “is concerning because it falsely suggests that EstroGel contains the lowest effective dose of estrogen […]
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July 11, 2018 – A booth display and a webpage for the investigational new drug (IND) Crenolanib besylate “suggest, in a promotional context” that the IND is safe and effective for the purposes for which it is being investigated and, therefore, misbrand it, according to an Untitled Letter issued June 28 to Arog Pharmaceuticals Inc. […]
Read more July 2, 2018 – The FDA’s Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter in 2018 to Pfizer Inc., claiming that a direct-to-consumer (DTC) video for the ESTRING® (estradiol vaginal ring), posted on the michiganmomliving.com site, as well as prepared Q&As provided to interview participants (and submitted to the agency under Form […]
Read more Feb. 23, 2018 – Companies, especially those that make opioid products, should make sure that promotional material displayed at conference exhibit booths clearly communicate their products’ risks and limitations of use, and that they heed advisory comments from the Office of Prescription Drug Promotion (OPDP), which issued an Untitled Letter to Collegium Pharmaceutical Inc. on Feb. […]
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Jan. 24, 2018 – In a dip from previous low-enforcement letter years, the Office of Prescription Drug Promotion (OPDP) issued a total of five enforcement letters in 2017, fewer than half the number of letters issued in 2016 (11). Of the five enforcement letters sent this year, two were Untitled Letters and three were Warning […]
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Nov. 8, 2016 – When the votes are counted, expect many discussions on what will happen next. One thing is certain – there is change ahead. To get the real skinny on what will happen to medical marketing, attend the Coalition for Healthcare Communication post-election meeting next Wednesday and Thursday in Washington. Speakers from throughout […]
Read moreSept. 8, 2016 — The FDA’s Office of Prescription Drug Promotion (OPDP) takes issue with a conference panel for an unapproved cancer treatment in an Untitled Letter to Celator Pharmaceuticals Inc. issued Aug. 25. In the letter (CPX-351 Letter), OPDP states that a panel displayed at the June 2016 American Society for Clinical Oncology (ASCO) […]
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