April 18, 2022 – A recent enforcement letter from the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) to Bausch Health Companies Inc. takes issue not only with omission of risk information in a direct-to-consumer (DTC) video and a webpage of a healthcare professional website, but also with a lack of balance […]
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Oct. 4, 2018 – According to Center for Drug Evaluation and Research (CDER) Director Dr. Janet Woodcock, the FDA’s Office of Prescription Drug Promotion’s (OPDP’s) decreased number of enforcement actions is largely due to the agency’s concerns regarding First Amendment issues that have been raised in recent court rulings. Speaking at a Sept. 21 discussion […]
Read moreJan. 3, 2017 – In its last blast of 2016, the FDA’s Office of Prescription Drug Promotion (OPDP) sent Untitled Letters to two companies on Dec. 21, both citing videos available on YouTube that allegedly promote investigational new drugs (INDs) as safe and effective for the purposes for which they are being investigated. These Untitled […]
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Dec. 15, 2016 – Television ads allegedly making false and misleading claims about the risks associated with their products were cited by the FDA’s Office of Prescription Drug Promotion (OPDP) in Untitled Letters issued Dec. 12 to Celgene Corp. and Sanofi-US. These letters bring the total number of Untitled Letters issued this year up to […]
Read more Sept. 15, 2016 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has only issued four enforcement letters this calendar year, it issued two Untitled Letters within two weeks for the same alleged infraction: promoting an investigational drug. In a Sept. 8 letter to DURECT Corp. and Pain Therapeutics Inc. (remoxy-untitled-letter), OPDP raised concerns […]
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July 22, 2016 – Although 2015 was considered a slow year for enforcement letters issued by the FDA’s Office of Prescription Drug Promotion (OPDP) – just nine total enforcement letters – so far this year OPDP is lagging behind that figure, having issued only one Untitled Letter and one Warning Letter between the beginning of […]
Read moreJan. 25, 2016 – The Office of Prescription Drug Promotion (OPDP) kicked off 2016 with a Jan. 14 Untitled Letter to Hospira Inc., a Pfizer company, citing a video posted on YouTube that presents information about what to expect from Hospira’s Precedex™. OPDP states in the letter that the video “is false or misleading because […]
Read moreMay 23, 2014 – The FDA’s Office of Prescription Drug Promotion (OPDP) has issued just three Untitled Letters to date in 2014, but all of them cite companies for omitting risk information or omitting material facts in various promotional venues, including a printed sales aid, a Facebook page and a sales sheet. “Clearly, omission of […]
Read moreJuly 16, 2012 – The FDA’s Office of Prescription Drug Promotion (OPDP) is on pace to deliver the same number of enforcement letters it sent out in 2011, having issued 15 Warning or Untitled Letters to date in 2012. OPDP had issued 17 such letters by this point in 2011. The seven enforcement letters sent […]
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