How Real Is the FDA’s Tough-Talking Crackdown on ‘Surreal’ Drug Ads?

Well the Doc opened up the old mailbag today and here’s what poured out.

Dear Dr. Ads,

There I was, minding my own business and leafing through the Wall Street Journal, when I came across this piece by Joseph Walker and Suzanne Vranica about the Food and Drug Administration’s latest effort to butch up its oversight of pharmaceutical advertising.

The surreal world of TV pharmaceutical ads, where people with terrible diseases tend to be young, beautiful and living life to the fullestsometimes with animated monstershas been parodied on late night sketch comedy shows.

But the drug industry’s biggest critic may turn out to be government regulators inside the Food and Drug Administration.

The FDA is cracking down on direct-to-consumer ads on the directive of President Trump. The agency issued letters to drugmakers last week, citing misleading storytelling with embellished scenes of picture-perfect health. Companies should cease and desist airing misleading ads, which violate federal law around the marketing of prescription drugs, the agency said.

Seriously, Doc – this is like the umpteenth time the FDA has made threatening noises about cracking down on drug ads, with no visible effect on the Big Pharma Distraction Machine. Why would this be any different?

– Food and Drug Sadministration

Dear FDS,

First off, about that guy and his blobby blue friend . . .

In a Pfizer ad, a young man is sitting on the couch next to a blue-skinned, five-eyed creature who runs to the camera and starts licking the screen like a puppy. The man explains that “this thing” is what’s happening inside of him, an inflammatory bowel disease called ulcerative colitis.

“It wasn’t always this calm,” he says. A flashback scene shows the creature, now blood-red, tearing through his home like a wild animal.

“But then I found out about Velsipity, a new once-daily pill,” the man says, back on the couch in the present day with the more docile blue creature.

Cue the Big Pharma Distraction Machine: “The frames that follow show the relatively well-behaved creature following him around as he enjoys a barbecue with friends,” while the soothing voiceover gently reminds viewers that “Velsipity may cause serious side effects including infections that can be fatal . . . certain types of skin cancer . . . swelling and narrowing of the brain’s blood vessels . . . ” and etc.

See for yourself . . .

According to the Journal piece,  the FDA’s letter to Pfizer (one of “100 letters notifying companies that their ads were out of bounds, compared with just a handful of letters in the past two years”) complained that “the magnitude of change depicted in the visuals implies a greater improvement in clinical remission than had been demonstrated” in studies.

Pfizer’s response? Yeah, whatever. (Two years ago the FDA told drugmakers in no uncertain terms to cut the crap in their direst-to-consumer ads, with up to zero effect.)

This latest regulatory spasm comes hard on the heels of last week’s semi-tough talk from the Trump administration, as the Journal’s Walker and Vranica reported.

The Trump administration is cracking down on pharmaceutical advertising—but stopped short of the worst-case scenario some drug and ad executives feared.

The moves could dent, but not demolish, the massive investment that the industry makes in pitching its products directly to consumers. Advertising, media and drug industry executives say they are relieved the government isn’t pushing for a complete moratorium on the ads, but some remain apprehensive about potential rule changes and their consequences.

(The pharmaceutical industry spends upwards of $11 billion a year on U.S. advertising, for those of you keeping score at home.)

Then again, all those federal crackdown efforts could be as fleeting as toe fungus in a Jublia commercial. As Lizzy Lawrence and Ed Silverman reported at STAT, “experts questioned whether the Food and Drug Administration has the resources to prosecute this aggressive campaign after laying off many of the experienced staff who would lead the effort. ‘What happens when those 100 responses come in, and how is FDA going to prioritize its review of those?’ said Joshua Oyster, a partner at Ropes & Gray. ‘How is the FDA going to prioritize follow-up actions, if any, in response to those responses?’”

The Doc’s diagnosis: Call it the Food and DOGE Administration. Just don’t expect it to answer the phone.

One comment on “How Real Is the FDA’s Tough-Talking Crackdown on ‘Surreal’ Drug Ads?

  1. […] it’s kind of not, as the Doc recently chronicled regarding the FDA’s attempted crackdown on “surreal” ads. […]

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