FDAnews Marketing and Sales Bulletin

GlaxoSmithKline (GSK) and Schering-Plough received letters from the FDA’s Division of Drug Marketing, Advertising and Communications regarding professional detail aids used by sales representatives for nasal sprays Flonase and Nasonex, according to the FDA.

GSK’s professional aid made unsubstantiated superiority claims for Flonase (fluticasone propionate), omitted material facts about the product and claimed that the product was more effective than what has been clinically demonstrated, according to the FDA.

The unsubstantiated claims included the phrase “superior reduction in patient-rated total nasal symptom scores … versus Nasonex,” the agency letter said. “These claims and presentations are misleading because they suggest that Flonase is superior to Nasonex for the treatment of seasonal allergic rhinitis symptoms, when this has not been demonstrated by substantial evidence or substantial clinical experience,” the FDA said.

In addition, the firm omitted material facts by not including the complete indication in the aid, such as a material limitation to the approved indication. The sales aid also overstated the product’s efficacy by misleading physicians that Flonase was approved for treating nasal congestion, according to the FDA.

“When nasal congestion is certain, but the triggers are not, prescribe Flonase first,” the sales aid said.

Similarly, Schering’s sales aid overstated the efficacy of Nasonex (mometasone furoate) by suggesting in multiple prominent references that the product was also indicated for congestion, the FDA said.

“In the presentation of data related to congestion alone, the detail aid repeatedly states or suggests that Nasonex is effective in the treatment of the specific symptom of nasal congestion, when this has not been demonstrated by substantial evidence or substantial clinical experience,” the FDA said. The sales aid stated, “Nasonex for big congestion relief night and day.” 

The aid also promoted unsubstantiated superiority claims by stating that patients preferred Nasonex’s taste and scent, the agency said. “The claim of ‘overall patient preference’ for Nasonex is misleading because it is based on patient responses to a single question in the ‘overall preference questionnaire’ that assessed eight product sensory attributes,” the agency added.

“The use of responses to this single question is not sufficient to support the broad concept of overall patient preference because patient preference cannot be adequately measured by a single item in an instrument. Patient preference encompasses multiple aspects of patient experiences such as convenience, ease of use, dosing, dosage form, all aspects of efficacy and adverse events,” the FDA said.

Schering said it has suspended use of the professional detail aid. “Schering takes FDA’s concerns seriously and is working with the agency to resolve the matter,” the company added.

GSK said that although it stopped detailing Flonase in 2006, it will use the untitled letter from the FDA as guidance in developing future promotional material for Flonase follow-on Veramyst (fluticasone furoate). The firm will launch the nasal spray in late May, GSK said.

The untitled letters can be viewed at www.fda.gov/cder/warn/2007/NasonexNOVletter.pdf and www.fda.gov/cder/warn/2007/FlonaseNOVletter.pdf.