|The FDA says Allegra promotional materials are misleading.
The FDA's Division of Drug Marketing, Advertising and Communications said two TV spots, a print ad and a fulfillment letter contain false or misleading statements.
Deadline for plan of action
A representative from Allegra did not return a call at press time. The letter, sent to Aventis' director of regulatory affairs, Kerry Rothschild, was apparently received several days ago; the pharmaceutical maker had until today to present a plan of action to the FDA to comply with the charges.
In its letter to Aventis, the FDA quoted from the drug's ad copy: "Allegra is specifically designed to block the histamine that triggers allergic responses," and "clinically superior to other prescription antihistamines." According to the copy, Allegra calls itself "the number 1 prescription antihistamine" because it is "specifically designed to block the histamine that triggers allergic responses."
Same mechanism as rivals
The FDA found the superiority claim misleading, because other popular prescription allergy remedies, such as Zyrtec and Clarinex, "have the same [allergy-blocking] mechanism of action ... your suggestion of a unique mechanism and superior effectiveness for Allegra is false or misleading."
Interpublic Group of Cos.' McCann-Erickson Worldwide, New York, created the ads. Aventis spent $98.5 million on Allegra in measured media through October 2003, according to TNS Media Intelligence/CMR.
$2 billion in sales
Allegra is Aventis' biggest-selling drug, with $2 billion in sales through October 2003, but the product is facing stiff competition from over-the-counter versions of the drug, including Schering-Plough's Claritin.
Aventis, based in Strasbourg, France, with U.S. headquarters in Bridgewater, N.J., is the 11th largest pharmaceutical maker in the world, with $6.9 billion in sales through October of last year, according to IMS Health.