FDA to Sunovion: Stop Distributing ‘Misleading’ Brochures
The U.S. Food and Drug Administration has asked Marlborough-based Sunovion Pharmaceuticals Inc. to stop distributing promotional brochures for respiratory drug Brovana that it considers deceptive, according to a letter released Tuesday.
“The patient brochures are misleading because they overstate the efficacy of Brovana, make unsubstantiated claims, including unsubstantiated superiority claims, and minimize the risks associated with the drug,” the FDA’s Office of Prescription Drug Promotion wrote in a six-page letter.
Sunovion spokeswoman Tricia Moriarty confirmed the company has received the letter.
“Sunovion takes compliance matters very seriously and has initiated a review of the issues raised…in the letter,” the company said in a statement. “Sunovion remains committed to complying with all applicable requirements related to Brovana.”
The FDA criticized several statements in Sunovion’s advertising materials, including the tagline of “Get back into daily living.” The FDA said the statement suggests patients can resume their baseline activities of daily living, while clinical studies have found Brovana produces just an 11 percent improvement in breathing for people suffering from chronic obstructive pulmonary disease.
Questions and corresponding statements such as “Do you feel you’re just not able to breathe in all your medicine?” and “When I use my inhaler, it just doesn’t feel like I’m able to breathe in all of the medicine, or that all the medicine is coming out” suggest that Brovana will be effective for patients who haven’t had success with other therapies, the FDA said, while no head-to-head studies support the assertion Brovana is clinically superior to other drugs.
Finally, the FDA chided Sunovion for presenting risk information in a single-spaced small font surrounded by little while space.
“The overall effect of this presentation undermines the communication of important risk information, minimizing the risks associated with Brovana, and misleadingly suggests that Brovana is safer than has been demonstrated,” the FDA wrote.
The FDA asked Sunovion to respond by Nov. 7 and let it know whether it plans to stop handing out these brochures.
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