Aug. 30, 2021 – In an Aug. 9 Untitled Letter, FDA’s Office of Prescription Drug Promotion (OPDP) cited Eton Pharmaceuticals Inc. for presenting benefit information in sponsored links for Alkindi® Sprinkle (hydrocortisone) oral granules without including any risk information about the product, which “is used in a vulnerable pediatric population” and may cause serious adverse […]
Read more Oct. 12, 2020 – The FDA’s Office of Prescription Drug Promotion (OPDP) enforcement efforts are picking up steam following a slow start – just one enforcement letter issued between January 2020 and July 2020 – with two recent Warning Letters resulting from complaints through the agency’s Bad Ad Program. In a Sept. 22 Warning Letter […]
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Aug. 5, 2019 – In two new Untitled Letters, the FDA’s Office of Prescription Drug Promotion (OPDP) makes clear that omitting risk information, misrepresenting product efficacy and using visuals that distract from risk messaging in direct-to-consumer (DTC) broadcast ads may draw the agency’s enforcement attention. In a July 25 Untitled Letter to CooperSurgical Inc., OPDP […]
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Feb. 19, 2019 – In a move that “merits industry attention,” the Federal Trade Commission (FTC) announced last week that it had joined the Food and Drug Administration (FDA) in enforcement actions against three companies advertising that their products can treat diseases like Alzheimer’s, according to a Feb. 11 post by Lesley Fair, senior attorney, […]
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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