The FDA targeted DTC, video, unapproved drug promotion in 2016

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Sanofi's ad for Toujeo received an untitled letter for distracting scene changes during risk presentation.

The FDA is taking a closer look at how drugmakers use channels like direct-to-consumer advertising and video, a shift that has raised questions for pharmaceutical marketers.

On its face, the FDA's Office of Prescription Drug Promotion's batch of enforcement letters in 2016 seems par for the course, with the agency issuing a total of 11 letters, compared to 2014's and 2015's totals of nine each. But these letters contain important warnings for drugmakers about the FDA's evolving views on promotion, and what channels, tactics, and drugs it's examining closely, according to experts interviewed for this story.

See also: The FDA issues untitled letters to Sanofi and Celgene over distracting ads

The OPDP in December issued two enforcement letters for DTC TV ads developed by Sanofi for its insulin Toujeo and Celgene for its psoriasis drug Otezla. Regulators said the ads were distracting to viewers because they used frequent scene changes — and, in Otezla's case, abrupt changes in music — to distract viewers from presented risk information.

These untitled letters were noteworthy because they signal a subtle shift in enforcement actions, with the FDA now examining tactics within DTC ads rather than focusing on bigger, more serious infractions, such as omitting risk information entirely, said Joanne Hawana, a partner at Mintz Levin.

See also: The FDA to study whether people can recognize misleading drug ads

“The FDA is now getting at some of the nuances of what it views as potentially misleading promotion,” she pointed out. “Yes, everybody know there's risks [and you have to present them] but that's no longer what drugmakers are getting charged with. It's the FDA saying the viewer couldn't understand it because the imagery was too fast moving or the music was too catchy in the background.”

Up until December, the OPDP was on pace for a record low amount of enforcement letters before it issued six in the span of one month. That significant boost raised eyebrows across the industry.

See also: 5 questions raised at the FDA's off-label hearing

“It's a trend that you can't deny,” said Bethany Hills, the chair of Mintz Levin's FDA practice. “I have not usually seen that kind of bulk [issuing of enforcement letters].”

She believes that the FDA may have been waiting until after its off-label hearing in November, to listen to drugmakers and other stakeholders before issuing the warnings. Her second theory is that the agency was trying to push the enforcements out the door before President-elect Donald Trump's inauguration on January 20 and any subsequent upheaval within the agency's leadership.

See also: Warning letters most often stem from missing risk information

On the other hand, John Kamp, executive director for the Coalition for Healthcare Communication, downplayed the timing, saying it was a coincidence. “It's end of the year and people [are] clearing their desks,” he said.

Kamp said the untitled letters for the DTC ads were a clear “shot across the bow” for two big companies: “Essentially it's saying, ‘OK, all these visuals during the risk presentation are distracting and you're not going to get away with that.' I think a lot of companies saw Celgene's and Sanofi's letters and said we've got to do a lot better job presenting risk information without interruptions.”

See also: Drugmakers spar with FDA over proposed DTC animation study

The FDA may be well aware of the challenges raised by the shift in regulatory actions. It proposed two studies in March to examine the nuances of DTC, saying then that it would investigate the effects of superimposed text, or text placed over an image, as well as consumers' perception of animated characters in DTC ads.

Video was far and away the most targeted medium by OPDP's enforcement letters last year, with six letters sent for promotion using YouTube videos, key opinion leader videos, and DTC advertising.

EXPERIMENTAL PROMOTION

Another major takeaway from 2016's enforcement letters was the agency's attention to promotion for experimental drugs. Out of the 11 letters issued in 2016, four of them targeted experimental drugs. In the two years prior, the OPDP only issued one enforcement letter for an unapproved, or investigational, drug.

The reason for the uptick may be that the agency sees experimental promotion as an easy target for enforcement actions, in light of the lawsuits it has faced over regulating off-label uses of approved products, according to Hills. “It makes it easier for the agency,” she said. “They're unlikely to get into litigation over First Amendment protection,” when it goes after experimental drugs.

See also: Why the FDA's view of patient communication evolved over time

Kamp agreed, saying that going after pre-approval promotions was clearly “low-hanging fruit” for the agency.

In one of the more head-scratching letters sent last year, Celator Pharmaceuticals received an untitled letter for its promotion of an investigational acute myeloid leukemia treatment, CPX-351, for a print panel at the American Society of Oncology meeting in 2016.

See also: The FDA denies approval of abuse-deterrent opioid after promotional warning

“I wouldn't have expected this to be an enforcement,” said Hills, noting that the panel only contains bullet points from a preclinical study and a Phase-III study, but it doesn't make any safety and efficacy claims.

The tipping point for sending out this enforcement letter was largely the setting, Hawana said, saying it was a crime of context. “Everything around [their print panel] at ASCO was for approved products. There was no disclaimer. They used a brand name, and it was put in a room with other approved products,” she pointed out.

“Executives need to pay attention to their investigational marketing or investigational speech — a lot of times companies don't think about that as promotion,” Hill added. 

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