DDMAC demands corrective messaging from three companies

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The FDA hit three companies with warning letters for promotional materials on three drugs and requested corrective communications for all three.

The move suggests that requests for corrective communications -- which could range from "Dear Doctor" letters to TV ads of the sort Bayer ran for Yaz as part of a settlement last year, are becoming standard practice at the agency.

At issue were promotional materials for two treatments for pain and inflammation associated with eye surgery – ISTA Pharmaceuticals' Xibrom and Sirion Therapeutics' Durezol – and a heavy-duty pain drug, Actavis' Kadian.

A professional sales aid for Xibrom presented unsubstantiated superiority claims, broadened the indication, overstated efficacy, omitted and minimized important risk info and made misleading patient preference claims, the agency's Division of Drug Marketing, Advertising and Communication said. In particular, materials for the NSAID, which is indicated for postoperative inflammation and pain in cataract surgery patients, omitted “the most serious warnings” and precautions associated with the class, including potential for allergic reactions that can result in anaphylaxis and potentially life-threatening asthmatic episodes, among other conditions.

A sales aid and z-card for Durezol, indicated for inflammation and pain associated with ocular surgery, omitted and minimized important risk information, overstated efficacy, promoted an unapproved dosing regimen and made unsubstantiated claims. The 16-page sales aid, the agency said, “presents numerous efficacy claims on both its front and back covers and on pages 1-12 but fails to convey any risk information specific to Durezol on these pages,” relegating the only specific risk disclosure to the end of the sales aid.

“We note the statement ‘Please see page 14 for Important Safety Information' is included on several pages of the sales aid,” the Feb. 18 warning letter said, declaring the sentence insufficient.

A co-pay assistance program brochure for Kadian Capsules, an extended-release morphine formulation for the treatment of moderate to severe pain when an around-the-clock opioid analgesic is needed, omitted and minimized serious risks, broadened the indication and failed to present limitations, and presented unsubstantiated superiority claims, the agency said. Kadian is a Schedule II controlled substance and carries a boxed warning. While that information was included, other serious risks—some potentially fatal—were not, and some risk information was rendered indecipherable to patients.

“Specifically, the back cover includes the boxed warning and some information from the adverse reactions section of the PI,” said the letter. “However, these serious, potentially fatal risks are presented in highly complex, medically technical language that is not likely to be understood with consumers.” A Q&A “suggests that patients with broader types of chronic pain than the drug is indicated for are appropriate candidates for Kadian therapy,” which the agency deemed “particularly concerning considering the serious and potentially fatal risks associated with the drug.”

The company said in a statement: “Actavis responded to the FDA's letter regarding language in the product's promotional materials within the requested time frame, and is initiating changes to address the concerns. The response included the requested action plan.”

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