November 15, 2008
FDA raps Amgen, Bayer for promos
The FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) issued an untitled letter on a patient brochure for Amgen's Sensipar, which is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
DDMAC said the 12-page brochure is false or misleading because it omits and minimizes serious risks like that of adynamic bone disease and broadens the indication.
The brochure includes a removable PI with full-risk information in an interior pocket, but the agency said “this does not mitigate the misleading omission and minimization of risk information in the brochure itself.”
Amgen told Reuters it has ceased dissemination of the brochure, in compliance with DDMAC's request.
The Oct. 27 letter came the same day that the agency issued warning letters to Bayer HealthCare for illegally marketing two OTC aspirin combos. Those letters, concerning Bayer Aspirin With Heart Advantage and Bayer Women's Low Dose Aspirin + Calcium, came two weeks after a pair of powerful congressmen scolded the agency for inaction on the matter. Reps. John Dingell and Bart Stupak (both D-MI) had written FDA to complain that Bayer HealthCare “ignored FDA recommendations to refrain from marketing such combination products.”
The agency said of both: “Notwithstanding your attempt to market this product as a combination drug-dietary supplement, the presence of aspirin in this product…renders the entire product a drug.”
It was the second time in a month that the agency has warned Bayer on promotions. On Oct. 3, DDMAC slapped the company with a warning letter on TV ads for YAZ.