FDA cites Janssen, Sobi for overstating benefits, understating risks in DTC TV ads

The US Food and Drug Administration (FDA) recently cited Johnson & Johnson subsidiary Janssen and Sobi for airing direct-to-consumer (DTC) television ads that failed to sufficiently disclose the risks associated with their drugs and for making claims that overstate the drugs’ benefits.

Tremfya

FDA sent an untitled letter to Johnson & Johnson stating that the firm made misleading statements in a DTC television ad for its drug Tremfya (guselkumab) used to treat plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The agency argued that the claims in the ad are not supported by results from the clinical studies used to approve the drug.

In the ad, a narrator states that, “Many people experienced remission at 1 and even 2 years” with text that reads, “MANY PEOPLE EXPERIENCED REMISSION at 1 and even 2 years.” Simultaneously, the ad also includes a fine print that reads, “~1 out of 2 patients were in clinical remission at 1 year and at 2 years.” However, regulators said that those claims overstate what the clinical studies determined.

The agency stated that the clinical studies section of the FDA-approved prescribing information (PI) summarizes that, among patients treated with Tremfya 100 mg subcutaneous injection every eight weeks or Tremfya 200 mg subcutaneous injection every four weeks in the maintenance trial (UC2), about half achieved clinical remission at Week 44. However, the agency noted that the trial only evaluated a subset of patients who achieved clinical response after 12 weeks of treatment with intravenous Tremfya in the induction trial UC1 or the induction dose-finding study UC3 so it was not representative of the overall patient population that was tested.

"In UC1 and UC3, 62% and about 61% of patients who received Tremfya demonstrated clinical response at Week 12, respectively," said FDA. "Therefore, it is misleading to suggest that 'many people' or '~1 out of 2 patients' treated with Tremfya will achieve clinical remission at one year when in fact, 38% and about 39% of patients in UC1 and UC3, respectively, did not respond to treatment at Week 12.

"Because it is misleading to suggest that 'many people' or '~1 out of 2 patients' treated with Tremfya will achieve clinical remission at one year, it is further misleading to suggest that 'many people' or '~1 out of 2 patients' will not only achieve remission at one year but also go on to maintain their remission through two years," the agency added.

FDA also said the ad's claim of 2 years is a misleading overstatement, since the results were based on the long-term extension trial QUASAR, which enrolled a subset of patients. They also noted that the ad stated that some users saw 100% visible healing of their intestinal lining, which is an overstatement because it suggests the drug can cure patients with moderate to severe active ulcerative colitis. The agency argued that the endoscopic results don't guarantee that patients will achieve a long-term cure with the drug.

"We acknowledge the disclaimer, 'Visually assessed areas may not represent remission of the entire colon lining. Individual results may vary,'" said FDA. "However, the inclusion of this statement does not correct or mitigate the misleading suggestion regarding Tremfya treatment described above.

"The TV ad includes the claim, '1 out of 3 patients achieved endoscopic remission at one year' (SUPER, 0:18 and 0:34)," the agency added. "This claim misleadingly overstates the efficacy of Tremfya by suggesting that a third of patients treated with Tremfya will achieve endoscopic remission at one year, when this is not the case."

While the agency said the company overstated the benefits, it also said the ad downplayed the drug’s risks by omitting the fact that the medication could reduce immune system's ability to fight infections.

Vonjo

FDA also sent Sobi an untitled letter for airing a DTC TV ad for its drug Vonjo (pacritinib) intended to treat adults with certain types of myelofibrosis (MF) who have a platelet count below 50,000 per microliter. The agency argued that the portrayal of someone treated with the drug is misleading because it suggests it can improve their emotional and social functioning.

The ad shows an elderly man spending his time walking his dog, engaging with friends, and dancing. Regulators argued that the portrayal overstates what the drug can do compared to other treatments.

"The totality of these claims and presentations makes the TV ad misleading by suggesting that Vonjo allows patients to 'turn the page' by impacting their health-related quality of life, such as improving their emotional functioning (i.e., no longer being tired or in distress) and social functioning (i.e., having greater ability to do activities of their choosing)," said FDA. "We note that one of the two coprimary efficacy endpoints in the PERSIST-2 trial was the proportion of patients with ≥50% reduction in the Total Symptom Score (TSS), a clinical outcome assessment of signs and symptoms of myelofibrosis (MF) that directly assess how a patient feels, functions or survives, from baseline to Week 24.

"However, the TSS endpoint failed when compared to the best available therapy (p=0.08)," the agency added.

FDA also said the ad did not adequately explain the indication that the drug was approved for, and while it states the benefits, it also omits important risk information.

"First, the TV ad fails to communicate that bleeding can be severe, changes in electrical activity of the heart can be life-threatening, and diarrhea is common and can also be severe," said FDA. "Second, the TV fails to communicate material information from the 'What are the possible side effects of VONJO?' section of the PPI that increased risk of major cardiovascular events such as heart attack, stroke, or death in people have happened, especially in those who have cardiovascular risk factors (emphasis added)."

Finally, FDA said that viewers are inundated with "attention-grabbing visuals, frequent scene changes, and background music" when the ad presents the major statement which interferes with their comprehension of the major statement.

Untitled letters

FDA cites Janssen, Sobi for overstating benefits, understating risks in DTC TV ads

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