Tag Archives: pharmaceutical advertising

Can the Trump Administration Finally Drag Drug Ads Into FDA Compliance?

by doctorads

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 clicking through the Boston Globe, when I came across Gerry Smith’s Bloomberg piece about a pharmaceutical company that actually did what the Food and Drug Administration said to do about its TV spots.

Alnylam Pharmaceuticals Inc. has stopped airing a TV commercial for its new heart medicine, a sign that the Trump administration’s crackdown on the industry’s ubiquitous drug ads is having an impact on the media landscape.

Alnylam was one of many companies to get letters last month from the US Food and Drug Administration calling out what the agency believes are misleading commercials. Most of the letters, sent to companies including AstraZeneca Plc, Bristol Myers Squibb Co., and AbbVie Inc., detail concerns with their online, broadcast, and print marketing, ranging from hiring actors who appear too healthy to omitting key safety risks.

Whaddaya think, Doc – is the Food and Drug Sadministration finally breaking through after years of being told by drugmakers to screw off?

– Medicine Man

Dear MM,

As TV reporters often say (when they have nothing to say), time will tell. Meanwhile, the Alnylam commercial in question – for the new heart medication Amvuttra – is nowhere to be found on Google or YouTube. According to the Bloomberg piece, however, the spot showed patients who were way too exuberant while “traveling and participating in activities like whale-watching and jumping up and down while cheering at a football game.”

The ad was misleading, the FDA said, because it suggested that patients “can be carefree” about the heart disease that the drug treats.

“The totality of these claims and presentations also misleadingly suggests that treatment with Amvuttra will broadly improve a patient’s overall quality of life when this has not been demonstrated,” wrote George Tidmarsh, the head of the FDA’s Center for Drug Evaluation and Research, on Sept. 9. The company was asked to address the violations, including by halting communications the FDA found misleading.

In response, Alnylam pulled the ad, saying “It’s standard practice to pause advertising while changes are being considered.”

(Actually, it’s kind of not, as the Doc recently chronicled regarding the FDA’s attempted crackdown on “surreal” ads. )

The Alnylam pullback means the FDA is batting .010 so far out of its 100 cease-and-desist letters to pharmaceutical companies.

The Doc’s diagnosis:  Please note that Alnylam has a market cap of around $60 billion compared to, say, Pfizer’s $155 billion. Or AstraZeneca’s $255 billion. Or AbbVie’s $413 billion. So the FDA basically hooked one of the minnows in the Pharma pond. Wake us when they land a big fish, yeah?

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

by doctorads

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 fullest—sometimes with animated monsters—has 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.

Can RFK Jr. Really Make Pharmaceutical Commercials Too Costly to Run?

by doctorads

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 reading Brian Stelter’s Reliable Sources newsletter, when I came across this item about the latest incarnation of Health and Human Services head Robert F. Kennedy Jr.’s jihad against Big Pharma.

Robert F. Kennedy Jr.‘s HHS is weighing a pair of policies cracking down on direct-to-consumer drug ads by making them more costly to produce. The rules could potentially “leave broadcasters in financial straits,” as they would choke off a crucial revenue source, CNN’s Liam Reilly and Tami Luhby report. Full story here…

What the hey, Doc – will RFK Jr. stop at nothing to land his white whale?

– Bitter Pill

Dear BP,

As you might have noticed, the Doc has been on Bobby Brainworm (pat. pending) like Brown on Williamson for months now over his Just Say No to Drug Ads campaign. Here’s the latest brainstorm from RFK Irregular, as detailed by CNN’s Liam Reilly and Tami Luhby.

While not an outright ban, the two policies would make it significantly more difficult and expensive for drug companies to push their products across broadcasters’ airwaves, according to a Bloomberg report on Tuesday. The policies look to either mandate that advertisers elaborate on the risks posed by their drugs — forcing ads to be longer and, therefore, more expensive — or bar drugmakers from writing off direct-to-consumer ads as business expenses on their taxes, also padding the bill, Bloomberg reported.

We’re talking real money here, folks: “Companies spent $10.8 billion in 2024 on direct-to-consumer pharmaceutical advertising in total, according to a report from the advertising data firm MediaRadar,” says Rachel Cohrs Zhang in her Bloomberg piece.

A whopping 59% of that money goes to TV spots. Case in point: “AbbVie alone spent $2 billion on direct-to-consumer drug ads last year, primarily on advertising for the company’s anti-inflammatory drugs Skyrizi and Rinvoq.”

Representative sample . . .

Annoying? Perhaps. Lucrative? Definitely. “The medicines brought in more than $5 billion for AbbVie in the first quarter of 2025.” That’s $5 billion in three months (annualized return on investment: 1000%) for those of you keeping score at home.

Meanwhile, “Senators Bernie Sanders and Angus King [have] introduced a bill to ban all prescription drug advertising,” according to Chris Williams at Fox News, thereby taking on both the pharmaceutical and broadcast industries.

Wake me when people start saying, “Doctor, I don’t see spots before my eyes.”

Why Is a Veteran Pharma Ad Copywriter Campaigning Against Pharma Ads?

by doctorads

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 checking out MediaPost’s Pharma & Health Insider, when I came across Les Luchter’s piece about the latest alarms over the “harmful outcomes” that prescription drug advertising has on consumers.

Since 2014, nonprofit RxBalance has been battling what it calls the “undue influence” of pharma marketing by running its own campaigns with such partners as Georgetown University for “Are You Prescribing Under the Influence? “[of pharma], targeted largely at healthcare providers.

Now, RxBalance has begun focusing more on telling the general public how pharma marketing can be less than transparent.  It recently launched an effort against costly Medicare drugs, focusing in particular on evidence that Eliquis from Bristol Myers Squibb/Pfizer’s Eliquis is no more effective than generic Warfarin in preventing strokes caused by atrial fibrillation — despite ad boastsof being “a better treatment.”

I dunno, Doc – is this just another do-gooder whistling past the – ahem – graveyard? Maybe RxBalance should team up with Robert F. Kennedy Jr., assuming Bobby Brainworm actually gets to run the Department of Health and Human Services.

– Drug Story

Dear DS,

For starters, the Doc already dealt with RFK 2.0 and his pipe dream of banning pharmaceutical advertising on TV.  So that’s a dead letter. (Maybe he can lay it out in Central Park in the dead of night, yeah?)

It’s hard to imagine that a bunch of civilians will have any better luck, but RxBalance founder Lydia Green told P&H Insider that she sees signs the landscape might be shifting for Big Pharma.

A lot of what we’ve been doing over the last 10 years is trying to convince people of things they find hard to believe [such as] that a doctor would make a decision…based on something that a sales rep told them. Now it’s much easier. So many of the concepts embedded in care right now were not established 10 years ago. And the pandemic created a sense of distrust in authority. People are much more open to our message.

People, sure. Federal regulators? Maybe not so much.

Even so, Green dreams on: “I personally would be happy to see no pharma advertising, and no brand awareness advertising.” Ditto for the folks at Jacobin, “a leading voice of the American left, offering socialist perspectives on politics, economics, and culture.”

In a piece headlined Drug Ads Misinform Patients and Raise Health Care Costs, Helen Santoro reported that according to one study, “drugmakers spent almost $16 billion over [a] six-year period to advertise products that didn’t provide at least moderate health benefits compared with existing therapeutic options.”

What the ads did provide, however, was a fantastic bang for the buck, as Santoro notes. “[A] report by Intron found that the return on investment from direct-to-consumer drug ads is incredibly high, ranging from 100 to 500 percent.”

So there’s that . . .

The Doc’s prescription: Keep hitting on that hopium, all you reformers. But don’t operate any heavy machinery while doing it.

Is the ‘Ban Pharmaceutical Advertising’ Crowd on Drugs or Something?

by doctorads

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 starting to paw through the New York Times, when I saw Rebecca Robbins’ front-page story about incoming Trump administration officials looking to euthanize pharmaceutical ads on TV.

Since the late 1990s, drug companies have spent tens of billions of dollars on television ads, drumming up demand for their products with cheerful jingles and scenes of dancing patients.

Now, some people up for top jobs in the incoming Trump administration are attacking such ads, setting up a clash with a powerful industry that has long had the courts on its side.

Robert F. Kennedy Jr., President-elect Donald J. Trump’s choice for health secretary, is a longtime critic of pharmaceutical advertising on TV, arguing that it leads broadcasters to more favorable coverage of the industry and does not improve Americans’ health. He has repeatedly and enthusiastically called for a ban on such ads.

What’s your professional opinion, Doc? Could Bobby Brainworm succeed where so many others have failed?

– On My Meds

Dear OMM,

Let’s start with a short history lesson, shall we?

Back in the ’90s, when the Food and Drug Administration first allowed pharmaceutical advertising to run on television, the ads could say the name of the drug but not what it did, or say what it did but not its name.

It was very Old Testament.

In 1997, though, the FDA bowed to the First Amendment and loosened it restrictions, “[allowing] drug manufacturers to describe the benefits of the drugs without providing long, detailed notices of the side effects. Instead, the F.D.A. said, the drug companies would be required to include in the advertisements a ‘brief summary’ of the major risks,” according to a Times piece that year.

Prescription drug commercials quickly developed a format to meet that requirement: The first half of the spot featured happy people living happy lives thanks to the wondrous effects of the drug; the second half featured a monotone voiceover intoning Contradictions & Side Effects (“Do not take Superion if you are allergic to it; side effects include headache, sudden death, something something something”) while images of windsurfers or giraffes or marching bands cranked up the Big  Pharma Distraction Machine.

(Nowadays, the Doc’s exposure to pharmaceutical commercials is largely limited to the ones that run on The Tennis Channel, most of whose viewers seem to be a) plagued by skin rashes, b) chronically short of breath, or c) allergic to whatever food their companion is enjoying.)

Those freewheeling days, however, appeared to be over when the FDA issued new rules for disclosure in the roughly $5 billion Big Pharma is slated to spend on national television advertising this year.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations concerning direct-to-consumer (DTC) advertisements (ads) for human prescription drugs presented in television or radio format and stating the name of the drug and its conditions of use (DTC TV/radio ads). Specifically, the final rule implements a requirement of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that in such DTC TV/radio ads, the major statement relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner.

Drive PhRMA nuts graf: “In ads in TV format, the information presented in the audio portion of the major statement must also be presented concurrently in text for a sufficient duration to allow it to be read easily. In ads in TV format, the information in text must be formatted such that the information can be read easily. The ad must not include audio or visual elements during the presentation of the major statement that are likely to interfere with comprehension of the major statement.”

Loose translation: No more giraffes!

Except . . .

In our admittedly unscientific survey, there ‘s been only one minor change in prescription drugs ads since the FDA’s drop-dead date of November 20: the addition of small type at the bottom of the screen during disclosure. Other than that, the distraction machine grinds on.

The Doc’s diagnosis: If the federal government can’t even effectively regulate pharmaceutical advertising on television, it sure as hell doesn’t seem capable of banning it outright.

Someone send RFK Jr. some migraine medication, wouldya?