King’s Promotional Material Is A ‘Serious’ Violation

The agency sent the drugmaker a harsh warning letter concerning its Avinza pill, which is a form of morphine that is specially made to provide long- acting relief of moderate-to-severe chronic pain. King was distributing a 22-page file card that the FDA determined is “false or misleading” because it overstates effectivness and “fails to communicate and minimizes risks.” Avinza, by the way, is a controlled substance and its labeling includes an extensive boxed warning, but King’s file card failed to include “any risk information from the boxed warning,” the FDA wrote. A slight oversight, no doubt.

Tom Abrams, who heads the FDA’s division of marketing, advertising and communications, writes: “We are especially concerned from a public health perspective because the File Card fails to present any information from the extensive Boxed Warning and Warnings sections of the approved product labeling for Avinza or any information about the abuse potential of Avinza, a controlled substance under Schedule II of the Controlled Substances Act.

“These omissions are exacerbated by the fact that the File Card minimizes the little risk information that is presented. In addition, the File Card fails to disclose the limitations to the indicated use of Avinza, thereby implying that Avinza may be used for a much broader range of patients and conditions than are appropriate for the drug. The File Card also makes several unsubstantiated efficacy claims about the outcomes of treatment with Avinza.

“The combination of such broad and unsubstantiated efficacy claims about the benefits of Avinza and the omission of the serious, potentially fatal risks associated with its use, as well as its potential for abuse, is especially egregious and alarming in its potential impact on the public health.”