FDA’s Division of Drug Marketing, Advertising, and Communications, last week, took Amgen to task for a DTC brochure that the agency deemed “false or misleading,” and claimed the company minimized side-effect information for the kidney treatment Sensipar.
On Tuesday, Amgen offered a statement to Pharm Exec explaining that the letter received was not a warning letter, but an untitled letter addressing alleged promotion violations that are less serious than those addressed in warning letters.
“Amgen is working closely with the FDA to address their concerns about the Sensipar patient education brochure,” the statement read. “We immediately ceased distribution of the brochure. Amgen is committed to responsible marketing that reflects the benefits and risks of our medicines.”
The 12-page brochure in question is an illustrated guide that breaks down, in layman’s terms, what hyperparathyroidism is, how it relates to chronic kidney disease, and what can be done about it. Amgen’s pamphlet spends a good deal of time explaining the benefits of Sensipar, but FDA took particular issue with the headline “Are there side effects?” Instead of merely noting the adverse reactions, FDA claims that Amgen handpicked the least problematic ailments and omitted the serious risk involved with taking the drug.
“The patient brochure prominently presents efficacy claims throughout several pages of the brochure with colorful graphics, ample white space, and descriptive headers,” stated DDMAC consumer promotion analyst Michael Sauers. “In contrast, the warnings and precautions that are disclosed in the brochure are presented in a single paragraph on the back cover.”
FDA requested that Amgen pull the brochure and submit a response letter by November 10.