Tag Archives: Food and Drug Administration

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.

How Long Can Pharmaceutical Advertisers Keep Telling the FDA to Screw Off?

by doctorads

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

Dear Dr. Ads,

Long time reader, second time writer . . .

There I was, still minding my own business four months after the Food and Drug Administration introduced new restrictions on pharmaceutical ads, when I came across Emma Yasinski’s piece at the non-profit MedShadow Foundation, asking whether the new FDA guidelines were making a difference in the five billion dollars worth of national television advertising bombarding U.S. consumers every year.

The FDA’s new rules establish guidance to ensure that TV and radio ads clearly communicate the risks and benefits of medications. They recommend measures such as keeping text on screen long enough to read, minimizing distractions from images and audio, and other strategies to help viewers fully grasp how a drug may affect them.

Still, this guidance—nearly 15 years in the making—warrants a closer look, especially given [HHS Secretary Robert F. Kennedy Jr.’s] stance that direct-to-consumer drug commercials should be eliminated entirely.

It’s also worth asking: Will it bring real change to the drug ads we’ve grown so accustomed to during commercial breaks?

According to at least one expert, the answer to that question is simple: No.

Looking for a second opinion on the state of the Pharmaceutical Distraction Machine (PDM), Doc. Any encouraging symptoms?

– On My Meds

Dear OMM,

If there’s been a measurable effect of the new FDA guidelines on prescription drug advertising, you can’t tell by looking.

Case in point: This national TV spot for Ponvory, “a once-daily pill for adults with relapsing MS [multiple sclerosis].”

PDM Index: Off the charts. primarily owing to a scene where Animated Girl runs about and nimbly climbs metal stairways while a sweet-voiced female announcer says, “Ponvory can increase your risk of serious infections that can be life-threatening and may cause death.”

Got that? Probably not – which is, of course, the whole point.

So how, you might ask, is the FDA supposedly enforcing its new advertising guidelines? Here’s how MedShadow’s Emma Yasinski describes the system.

:If the FDA determines that a company’s advertisements violate their updated standards, it can issue one of three types of letters: an It Has Come to Our Attention (IHCTOA) letter, an Untitled letter, and a Warning letter . . . A Warning letter is the most serious type of letter the FDA can send. It details violations and allows companies to respond and correct their violations within 15 days (or explain why it’ll take longer than that), before the agency takes enforcement actions, such as seizing supplies of the drug or taking the company to court.

But . . . “[FDA officials] have declined to say whether enforcement will go beyond issuing advisory letters—recommendations that, for now, carry no direct consequences for companies that choose to ignore them.”

Which is exactly what the companies are doing, to all appearances.

The Doc’s diagnosis: RFK Jr. wants to ban prescription drug ads; Donald Trump wants to gut the FDA, as Alexis Sterling detailed at the progressive website Nation of Change. Here’s betting that the Pharmaceutical Distractionb Machine keeps chugging along, despite any other mishegoss that rains down on the FDA.

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?

Did Juul’s Extremely Effective Advertising Effectively Trigger Its FDA Ban?

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 perusing the Weekend Wall Street Journal (the WSJ set doesn’t read, it peruses – just ask Peggy Noonan), when I came across this piece by Jennifer Maloney, Andrew Scurria, and Alex Harring about “a federal appeals court [that] granted Juul Labs Inc. a temporary stay of the Food and Drug Administration’s order for the vaping company to pull its e-cigarettes off the U.S. market.”

Here’s the part that jumped out at me.

Regulators and lawmakers have connected Juul’s fruity flavors, hip marketing and USB-like vaporizer to a surge of underage vaping in the U.S. in 2018 and 2019. Juul has said it never targeted teens. It halted most of its U.S. advertising and stopped selling sweet and fruity flavors in 2019, part of an effort to repair its relationship with regulators, lawmakers and the public.

Is that true, Doc – Juul never targeted teens? Sounds kind of vaporous to me.

– Jewel

Dear Jewel,

It’s more accurate to say Juul always targeted teens, as this New York Times piece by Steven Kurutz noted.

When Juuls were first sold in 2015, the brand surged in popularity, partly on the strength of a vibrant ad campaign that showed young people smiling, laughing and striking poses beneath the word “Vaporized.”

By 2018, Juul had grown so popular that the brand name became a verb, with teens furtively “juuling” in high school classrooms and hallways. That same year, Altria, the parent company of Philip Morris, agreed to pay $13 billion for a 35 percent stake in Juul Labs.

This 2020 piece by Terry Turner at Drugwatch was even more damning.

HOW JUUL CREATED A TEEN VAPING EPIDEMIC

Throughout the summer of 2019, as congressional staffers plowed through 55,000 documents Juul Labs had previously never made public, a picture emerged of a carefully planned effort to expose American kids to one of the world’s most addictive substances.

The documents revealed a perfect storm of stealth marketing, sleek design and high nicotine doses that Juul Labs seemingly engineered to slip under adults’ radar, buying time to addict kids to the company’s vaping products . . .

Congressional investigators found Juul Labs “deployed a sophisticated program” paying schools as much as $10,000 each to let company representatives deliver its message directly to children. In at least one presentation, without teachers or parents present, a company representative showed kids how to use a Juul e-cigarette. Other evidence showed that Juul Labs also targeted preteen kids through summer camps and out-of-school programs.

Overall, the Drugwatch piece noted, “Juul Labs’ internal documents and statements by its founders reveal the e-cigarette manufacturer lifted trade secrets from Big Tobacco to market its highly addictive vaping products to youths as young as 8. The company’s deliberate marketing plan proved successful, doubling the size of the U.S. vaping market and dominating competitors in just three years.”

Juul controlled over 75% of the e-cigarette market by then and was red hot among teens, as this 2019 Time magazine video detailed.

Here’s just a sample of the news reports that have tracked Juul’s marketing to kids over the past several years.

• The vape company Juul said it doesn’t target teens. Its early ads tell a different story.

• Juul Bought Ads Appearing on Cartoon Network and Other Youth Sites, Suit Claims 

• Juul, accused of marketing to teens, settles vaping case for $40m

Last week, Insider News posted this deep dive into the rise and fall (TBD) of Juul.

To recap:

• Youth cigarette smoking rates dropped from 18% in 2005 to 10.8% in 2015

• Thanks to Juul’s relentless targeting of teens on social media, its U.S. market share went from under 5% in 2016 to 29% in 2017 to 75% in 2018

• The FDA said whoa

• Juul phased out its social media accounts

That last, of course, meant nothing: Teenage Juulers kept the social media machine whirring quite nicely all by themselves.

Regardless, why does the FDA now feel comfortable canceling Juul while greenlighting VUSE and NJOY e-cigs?

Here’s the Doc’s diagnosis: During the past few years, Juul’s teen targeting has gone over like the metric system with the American public. Maybe that’s part of the FDA’s conclusion that Juul is the black hat and VUSE and NJOY are the white hats in terms of protecting the public health.

Your smoke and mirrors go here.