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The dancing couple. The slow-motion pan as the protagonists pick fruits at a farmer’s market. These are among the cinematic clichés employed by television drug commercials while a narrator intones the requisite laundry list of safety risks. 

Both well-worn techniques have also contributed to one of the most vilified aspects of pharmaceutical advertising: the Food and Drug Administration’s so-called major statement of side effects and contraindications.

“I’m not a big fan,” said Frank Mazzola, managing founder of Real Chemistry’s ad agency, 21Grams. “I don’t think it serves the purpose that it should serve, as it is right now.”

Consumers, for their part, don’t find it particularly fit for purpose, either.

“They tune that information out,” said Janelle Applequist, an associate professor at the University of South Florida’s school of advertising & mass communications.

Even if the company is satisfying a mandate for presenting a fair balance of risk and benefits, “it’s not ethically right,” she added during a September webinar organized by the Duke-Margolis Institute for Health Policy, in association with FDA. “You’re not doing well by consumers.”

A recently released FDA rule, set to become mandatory later this month, promises to aid compliance with the major statement, but not necessarily with how consumers understand it. Nevertheless, as new streaming and other digital platforms become the norm, and if more ads seek to integrate safety information with narrative storylines, improved comprehension could follow.

FD&C: a history

The fair-balance requirement has its roots in a 1930s law — the Food, Drug & Cosmetics Act (FD&C) — that requires prescription drug promotion to be “truthful and non-misleading.”

In the late 1990s, FDA developed a regulation that freed drugmakers from having to load up on risk information in their ads. It allowed TV and radio spots to share only the drug’s main side effects and contraindications, as long as the ad provided a way for consumers to obtain the ultra-lengthy list, known as the package insert. 

This paved the way for the ensuing direct-to-consumer ad explosion. But even as more and more firms became convinced of DTC’s value in stimulating physician-patient discourse, there was less consensus around how to meet the fair-balance standard.

In 2007, Congress amended the FD&C to say that presentation of risks in TV and radio ads had to do so in a “clear, conspicuous and neutral manner.” It took more than 15 years for the agency to specify exactly what that entails. 

To hear experts tell it, November 2023’s “CCN” rule isn’t so much newly promulgated policy as it is codification of various regulations over the years. It’s also consistent with FDA’s past enforcement actions and with what many marketers already consider normative procedure.

The ‘CCN’ way

The rule, which becomes mandatory on November 20, applies to product-claim related communications. In addition to TV drug ads, these also include sales aids, product websites and direct-mail pieces. It sets out five standards which, together, help ensure the major statement in a radio or TV ad adheres to the CCN mantra.

One standard requires consumer-friendly language, while two more regulate the style of text and use of audio. The so-called dual-modality standard requires the major statement to be presented in audio and text concurrently. 

The fifth is a blanket warning against anything likely to interfere with comprehension. In other words, regulators won’t just check for the mere inclusion of fair balance but also ensure that any background visuals don’t distract from the risk presentation. 

The agency’s intent isn’t to preclude additional creative during the major-statement section. On the contrary, the Office of Prescription Drug Promotion’s (OPDP) view is that multiple audio/visual elements during the major statement can reinforce comprehension and recall of the risk presentation while not decreasing recall or comprehension of benefits. 

In one sense, that’s the reason for requiring dual modality. Yet, marketers have run into trouble here. In December 2016, Sanofi received an untitled letter referencing a commercial for the drugmaker’s Toujeo insulin injection that featured a man continuously dancing to the song “Let’s Groove.” 

Dancing man

The “fast-paced visuals” of the man dancing while cooking and playing with his kids in the Toujeo spot compete for consumer attention, FDA alleged, making it difficult for viewers to adequately comprehend the risk information. 

“This is one [area] where there’s been lots of enforcement,” agreed Katie Graham, managing director of med-comms consultancy McKoy Consulting and a former medical science liaison and medical affairs manager who has taught promotional labeling. 

“It’s based on social science research that shows if you have lots of scene changes, your eyes move toward what’s going on in the imagery,” said Graham. “It’s harder to focus on that static language below because you’re trying to take in what’s happening.”

For this reason, FDA says, it made standard No. 5 — whereby other audio or visual elements that may interfere with comprehension are verboten — apply only during the major statement, not the rest of the ad. (Although, FDA says, upbeat music or amusing drawings are allowed.)

As a straight reading of the rule makes clear, “It is not our intent that the major statement be presented in a bland manner such that the audience becomes disengaged during this part of the ad, nor do we intend to require a ‘tombstone’ [i.e., strictly black & white] presentation of the major statement.” 

Applequist, though, says disengagement is exactly what’s at risk of occurring. 

“You’ve got happy visual portrayals on these TV ads. Enter in the risk information — the major statement — and it’s incredibly jarring for [viewers],” she argued during the Duke-Margolis webinar. “It’s interrupting that narrative flow and effectively erasing any of that positive experience that they had, and any of the benefits that were learned about that medication.”

Consumers seem ready for a less jarring presentation of the major statement. 

An anachronism?

The CCN rule isn’t likely to clear up what remains a confusing and, possibly, anachronistic requirement. The major statement, Mazzola said, made more sense during the era when relatively few people had a second screen in their pocket. 

In the late 1990s and early 2000s, the voiceover would have been among the few ways a person could learn about a drug’s safety information. Nowadays, he said, “Thinking about practical use, nobody’s sitting next to the TV with a pad and pen and following all that. So it sort of becomes just noise.”

Echoed Graham, “Right now, unfortunately, you get this kind of story flow with the efficacy, and then everybody just shoves the safety in at the end because we have to, versus folding that safety in [during the ad itself].” 

“It’s kind of a shame, because your mind kind of shuts off,” she added. “When you’re used to seeing the same kind of thing again and again, if it’s not what catches your attention.”

The average length of a major statement runs about 33 seconds, she noted, while attention spans average around eight seconds. Thus, something has to give — and often does. Graham said she frequently gets asked by clients to squeeze the major statement into a format that consumers can skip over in six seconds. 

That may be feasible for a product with relatively few safety caveats. However, for the vast majority of prescription drugs, “When you only have 60 seconds to tell a story, it’s really hard to fold in 33 seconds. So I understand the frustration,” she said.

Thus, the pharma industry finds itself in a fair-balance quandary: compliance with the CCN rule is mandatory, but meeting the requirements may not foster comprehension. One way to reconcile this, experts said, is by conveying risk information through a storytelling format. 

That is, by making the safety part and parcel of the ad, rather than an extension of it. To wit: In 2022 Genentech’s Hemlibra, a treatment for hemophilia A, invented a character — dubbed “Smitherton Gledhill, foremost expert in safety videos” — who duly delivered the required information in a fun yet compliant way. 

‘Smitherton Gledhill’

The ad featuring Gledhill, called Flair Balance, aired during a live Twitch event, increasing traffic to the Hemlibra site, including sign-ups for more information about the drug. The MM+M Awards honored the campaign for its ability to make the major statement “not just watchable, but also entertaining.”

“If we’re doing TV of any kind, it’s our intent from the beginning to integrate the safety into the actual spot. That’s our starting point,” said Mazzola, who’s also global chief creative officer of Real Chemistry.

21Grams, the agency behind Flair Balance, later did the same for Swedish Orphan Biovitrum’s Doptelet, a drug designed to boost platelet counts in adults with a rare chronic immune disease. This time, the ad’s central conceit involved an actor ostensibly reviewing his lines — which included the safety read — as he geared up for the taping of a Doptelet commercial.

“It’s a good practice for marketers to integrate safety into the story,” said Mazzola. “The more you make it part of the story, the better.”

Applequist agreed, adding that she believes consumers would respond “quite positively” to that technique and argued for more testing of its potential benefits. 

The industry isn’t quite there yet, however. Most TV drug ads still separate out the safety information at the end. And modern-day DTC ads still include a long list of adverse events with little context and confusing messages like, “Don’t take [product X] if you are allergic to [product X]” that consumers may find befuddling or even frightening.

A constant battle

“If the goal is for people to understand and absorb safety information, current guidance fails and gives the perception of ‘cover your a—’ rather than more common sense, helpful methods,” Mazzola argued. “This leads to further mistrust of our industry.”

To that end, he and others urged FDA to develop more user-friendly methods of helping consumers understand the risks associated with products, ones which account for a multiscreen world.

For example, if DTC commercials prompted viewers to “text 9999 for safety information,” interested parties could read the information and spend time with it, rather than commit a list of side effects to memory, Mazzola offered.

Moreover, ads running on connected TV (CTV) can be clickable and interactive. The ad can provide a “framing,” in which safety information can be persistent during the commercial, as opposed to an audible read.

Alternatively, Graham suggested use of a QR code to allow viewers to click and continue on to a longer video, which could allow for better integration of safety into the story.

These and other alternatives aren’t exactly commonplace at the moment. Until they are, pharma marketers are likely to face a constant battle between, on the one hand, meeting FDA’s requirements for the major statement and, on the other, competing for viewers’ short attention spans.