We are old enough to remember the “poke” function on Facebook, and too old to remember what purpose it served. We are similarly at a loss to understand the purpose of Facebook’s new policy requiring that pharmaceutical manufacturers, telehealth companies, and online pharmacies apply for …
In case you missed it, FDA took to email and social media earlier this week (the equivalent of shouting it from the rooftops) to announce that it has notified Amgen Inc. of Neulasta (pegfilgrastim) misbranding due to false or misleading promotion. This is OPDP’s second …
I would be lying if I said I hadn’t expected this most recent OPDP Untitled letter. OK, maybe not THIS letter. Some background: Back in November 2020, after an article was published about the ethical questions surrounding “Sponcon,” (sponsored content – for those not hip …
Well, it’s been busy for OPDP (and the Rx Ad/Promo bloggers over at the FDA Law Blog). After getting off to a slow start in 2021, OPDP issued yet another Warning Letter, apparently the day after its first. Unlike the first letter, this OPDP Warning …
Yesterday’s FDA Warning Letter, Press Release, and accompanying public relations campaign related to AcelRx’s promotional material for Dsuvia (sufentanil) are remarkable for exactly the reasons FDA intended them to be remarkable: these actions all signal to industry that despite anemic levels of FDA enforcement related …
On November 20, 2020, the Office of Prescription Drug Promotion (OPDP) hosted a webinar to announce a new process for review of “core launch” promotional materials. Specifically, OPDP has added a five business day screening period to the beginning of core launch review to ensure …
FDA is exercising significant emergency authorities during the COVID‑19 pandemic. Not all of industry is affected, but those who are manufacturing or distributing (or using) devices being used to fight the pandemic can benefit by understanding FDA’s emergency‑related policies and practices. These are evolving every …
Last Thursday, March 5, 2020, the FTC filed a formal complaint alleging deceptive marketing practices against tea and skincare company, Teami, LLC, and its co-founders, as well as a stipulated order for permanent injunction and monetary judgment. In conjunction with the filings, the FTC also …
Just as many object to holiday music in November, the Office of Prescription Drug Promotion (“OPDP”) objected in an untitled letter issued earlier this month to claims made for an investigational drug. The statements (since removed) appeared on a company website about an investigational drug …
After reading OPDP’s latest enforcement letter, we had déjà vu all over again and were transported back to 2016 when we blogged that OPDP was Not Dead Yet. At that time, OPDP had posted two enforcement letters on the same day relating to TV ads …
What is “truthful and non-misleading” in prescription drug promotion is often in the eye of the beholder. And, when it comes to enforcement, FDA is usually the arbiter. Over the years, FDA has taken on a number of initiatives and invested significant resources to better …
In its fourth enforcement letter of 2018, the Office of Prescription Drug Promotion (OPDP) takes aim at a marketed drug’s sell sheet solely on the basis of misleading efficacy claims, the first letter to do so in over 3 years. The letter, issued August 16 to …
Announced as another effort to improve patient access and address drug pricing, FDA recently finalized two guidance documents intended to facilitate better communication and negotiation with payors, formulary committees, and others: Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers: Guidance …
While likely not FDA’s intent, the net effect of FDA’s requirements surrounding importation of active pharmaceutical ingredients is driving manufacturing of investigational finished drug products outside the United States. In its most egregious implementation, FDA’s current interpretation sets up a Catch-22 in which a batch …
In January 2017, FDA issued two Draft Guidance documents concerning communications made by medical device manufacturers about information not expressly contained within a product’s labeling: Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers: Guidance for Industry [Draft] (January 2017), hereinafter …
