A print ad for Genentech’s Boniva overstated the osteoporosis drug’s efficacy, said the FDA’s Division of Drug Marketing, Advertising and Communication in an untitled letter.
The agency took issue with the claim in the ad, which features Sally Field, that: “Studies show, after a year on Boniva, 9 out of 10 women stopped and reversed their bone loss.”
The claim, said DDMAC, “is not supported by substantial evidence or substantial clinical experience” but rather “a per-protocol post-hoc responder analysis that the clinical study was not adequately designed to evaluate.”
Genentech, said FDA, is pulling violative promotional materials for the drug featuring that claim.
The ad that prompted the letter ran in Parade Magazine. It features an image of Field sitting on a pier, with the headline: “I wanted to stop my bone loss. But I did more. I reversed it with Boniva.”
Field has served as the face of the brand since 2006, when Roche and GlaxoSmithKline launched their “Rally with Sally for Bone Health” campaign.”