More FDA Oversight Of DTC Ads May Be Needed To Curtail Misleading Claims, Study Argues

Clearer US guidance on DTC TV advertising and stronger enforcement would help reduce misleading claims and encourage drug makers to include more qualitative benefit/risk information in ads, according to a new study from Yale University researchers published in the Journal of General Internal Medicine.

Researchers at Yale University advocated for more US FDA enforcement of direct-to-consumer (DTC) broadcast ads in a study published in the Journal of General Internal Medicine Feb. 26.

"It would be helpful if there were clearer and more detailed regulations and guidance for DTC broadcast ads, particularly with respect to providing quantitative risk information, along with better enforcement of current guidance," concluded the researchers. They recommended FDA consider charging a user fee to assure advertising oversight is appropriately staffed to review TV ads prior to airing.

Industry and FDA had agreed to a DTC user fee as part of the 2007 renewal of the broader program, but the new fee was quashed by Democratic lawmakers, and there appears little interest in reviving it at the moment.

Lack of enforcement may be giving some drug makers a yellow light to test the boundaries in television advertising, according to the researchers, who highlighted weight loss and blood pressure reduction claims as a common occurrence in ads for some diabetes drugs. All 13 of the ads in the study they viewed as promoting off-label claims were for diabetes drugs. (Also see "Diabetes DTC Ads Stand Out For Off-Label Promotion, Study Finds " - Scrip, 5 Mar, 2018.) The researchers reviewed 97 TV ads systematically as part of the study.

FDA's oversight of drug promotions generally appears to have declined significantly. The year 2017 marked a record-low in terms of the number of warning and untitled letters issued by the agency. (Also see "Rx Promotion Citations By US FDA Plummet; UCLA Webpage Elicits Final Letter Of 2017" - Pink Sheet, 23 Jan, 2018.)

In its most recent action, FDA issued an untitled letter to CSL Behring related to promotional materials for the hemophilia B drug Idelvion (coagulation Factor IX) featuring an image of a soccer player, arguing the material is misleading because it implies hemophiliacs can take part in high-risk activity if they take the drug.

Few Quantified Claims

"With the huge rise of DTC broadcast ads, I always wanted to look more closely at what are they saying," said Yale University Professor Joseph Ross – one of three authors of the study led by Kristina Klara – in an interview.

Ross said he was particularly disappointed the results showed a lack of quantified information around risk and benefit in TV ads. "It was not surprising to me, but it was a little disheartening," he said. "Is this advertising making things better or worse for patients?"

Statements to support benefits were rarely quantified, while statements around safety were never quantified, according to the results. The median time discussing benefits or indications was 55%, while the mean time discussing risks was 45%.

"We did find that the quality of information presented, particularly in the quantitative data, was low," the study says. The researchers pointed to two examples around efficacy statements. The first, an ad for Novo Nordisk AS's diabetes drug Victoza (liraglutide) states, "In our largest study, when added to metformin, people lost on average up to 6.2 pounds." In an ad for Johnson & Johnson's psoriasis drug Stelara (ustekinumab), the advertisement says, "Most people using Stelara saw 75% clearer skin and the majority were rated as cleared or minimal at 12 weeks."

In both cases, the researchers said the claims are vague and difficult to interpret, while providing conflicting descriptions of findings.

When it comes to disseminating risk information, all of the ads presented risk information accompanied by distracting visuals, such as frequent scene changes or characters dancing and singing, while 79% had running text on the screen during the audio risk presentation that was not related to risk like "see our ad in Weight Watchers," according to the study.

Nonetheless, the researchers acknowledge, "While we found potentially misleading information in the broadcast ads in our sample, we did not identify any claims that were blatantly false."

The study also found that 60% of ads referenced a method of payment and potential savings, which the researchers found to be controversial because they said while drug coupons can offset the cost of a brand-name drug in the short-term they are usually time limited and can result in higher health care spending more broadly.

Diabetes Drugs Targeted For Unapproved Claims

Yale researchers highlighted diabetes drugs for promoting claims like weight loss and blood pressure reduction for which the drugs are not approved. The study called out five diabetes drugs for off-label claims: Johnson & Johnson's Invokana (canagliflozin), Novo's Victoza, AstraZeneca PLC's Farxiga (dapagliflozin) and
Eli Lilly & Co.'s Jardiance (empagliflozin) and Trulicity (dulaglutide).

A TV ad for Farxiga, for example, said, "And although it's not a weight loss or blood pressure drug, Farxiga may help you lose weight and may even lower blood pressure when used with certain diabetes medicines."

An ad for Invokana stated, "And while it's not for lowering systolic blood pressure or weight loss, it may help you with both."

The SGLT-2 inhibitors are approved for improving glycemic control in patients with type 2 diabetes. The approvals were supported with clinical trial data demonstrating statistically significant improvement in weight and blood pressure in certain cases, and that data is included in labeling for the drugs, which is why drug makers are likely comfortable with the claims.

But Ross said the claims are troubling even though he acknowledged the lines are blurred.

"It's in the eye of the beholder," he said in an interview. "If the drug is not approved to lower your blood pressure should they be saying it in the advertisement? It certainly suggests it can be used for that purpose as opposed to being an ancillary benefit."

The public advocacy group Public Citizen sent a letter to FDA in 2015 asking the agency to crack down on weight loss claims in advertising for five diabetes drugs, which included four of the same drugs highlighted in the study, as well as AstraZeneca's Bydureon (exenatide extended-release) in place of Trulicity.

"It's definitely a gray area, and that's probably why FDA has not acted," Ross admitted. FDA said it plans to review the study, but had no other comment.

In December 2016, FDA did send an untitled letter to Sanofi for an advertisement for the insulin glargine product Toujeo, but that was for running fast-paced visuals and music while the risk information was being conveyed. (Also see "DTC Trouble: ‘Attention-Grabbing Visuals’ Undermine Risk Info, FDA Tells Celgene, Sanofi" - Pink Sheet, 15 Dec, 2016.)

The Yale study analyzed 97 unique ads representing 60 drugs that aired in the US from January 2015 through July 2016. Some drugs, like AbbVie's Humira (adalimumab), was advertised for multiple indications, so there were 67 unique-drug-indication combinations.

To reduce subjectivity, the ads were analyzed using a data collection instrument with 40 items, 26 of which were derived from federal regulations or FDA guidance, and 14 that described other characteristics. Of the 26 items, 11 were identified as key regulatory requirements, seven were chosen as indications of ads that were potentially misleading and eight as indications that ads might be lacking fair balance. Of the 14 descriptive items, 10 were developed to characterize ad appeal, including factors like the age and sex of the protagonist, whether real patients or celebrity patients were used, or whether the ad referenced saving money.