A Deeper Look at FDA's 2015 Enforcement of Drug Promotions

As mentioned in a previous post, the FDA's Office of Prescription Drug Promotion (OPDP) issued the fewest ever enforcement letters regarding non-biologic Rx drug promotions in 2015 (read "2015 Was Another Good Year for Orphan Drugs & Pharma Marketers").

Of the 9 letters OPDP sent to drug companies regarding violations, 2 were serious "Warning Letters" and 7 were "Untitled Letters." The following chart shows the Warning vs. Untitled letter trend from 2010 through 2015.

One Warning Letter went to Duchesnay for the promotion of Diclegis via Instagram. FDA cited 2 violations: (1) Omission of Risk Information (see "OMG. Kim Kardashian Shills for Pharma! No Worry - No Side Effects!") and (2) Omission of Material Fact (the post failed to provide material information regarding DICLEGIS’ full approved indication, including important limitations of use). The other Warning Letter went to a Valeant subsidiary for the promotion of Tussicaps. FDA cited 3 violations: (1) Omission of Risk Information, (2) Inadequate Communication of Indication, and (3) Unsubstantiated Claims.

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In-Video Drug Ads on YouTube: Should They be "Non-Skippable?"

Yesterday, I wanted to cook stuffed artichokes for dinner. So, I searched Google for a video and found this on YouTube: "ITALIAN STUFFED ARTICHOKES - SICILIAN STYLE - EASTER DINER RECIPE."

Before the cooking lesson started, there was an in-video ad for an Rx drug, the name of which I can't recall right now. No matter. After 15 seconds or so I realized I could click on "Skip Ad" and not hear any more of the side effects, aka FDA-required Important Safety Information (ISI), "major statement," and "Fair Balance" stuff that is usually crammed into Direct-to-Consumer (DTC) TV ads after about 20 or 30 seconds.

Ruth Day of Duke University once said of print and TV DTC drug ads (here): “Risk information is physically present but functionally absent.” This accurately describes what's happening in skippable in-video DTC ads on Youtube.

According to YouTube Help, there are two versions of in-video ads: (1) skippable ads like the one I saw, and (2) non-skippable ads.

It seems that pharma uses only the former, not the latter. Is this acceptable?

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