Two December Warning Letters Bring 2016 Tally Up to Three

Dec. 21, 2016 – The late year spate of enforcement letters from the FDA’s Office of Prescription Drug Promotion (OPDP) continued on Dec. 13 with two new Warning Letters sent directly to company heads, bringing the number of Warning Letters to three this year, plus six of the lesser Untitled Letters.

How clearly product risks are communicated is a common thread in the two new Warning Letters issued by OPDP that cited United-Guardian Inc. for false or misleading risk and benefit presentations in a professional e-mail, and Spriaso LLC for false or misleading risk presentation, inadequate communication of indication, and failure to submit Form FDA-2253 for a Web page.

In its Dec. 13 letter to United-Guardian, the OPDP stated that a professional e-mail for RENACIDIN® Irrigation Solution, indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube in lieu of surgical procedures, contains “multiple claims and/or representations about Renacidin; however, it fails to communicate any risk information.”

OPDP points out that promotional material can be misleading not only by the representations they make, but also by “failure to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the materials.” The “click here” link to complete prescribing information “does not mitigate the omission of the risk information from the e-mail,” OPDP states.

Further, benefit claims about the product made in the e-mail are not supported and omit specific information from the approved physician labeling.

The OPDP’s Dec. 13 letter to Spriaso states that its Website includes a page that “is concerning from a public health perspective because it creates a misleading impression about the safety and approved indication for TUXARIN ER™,” which is indicated for the relief of cough and respiratory symptoms associated with upper respiratory allergies or the common cold for adults 18 years of age and older.

OPDP takes issue with unsupported claims made on the Webpage about Tuxarin ER that omit any risk information about the product. According to OPDP, specific claims about the product are misleading “because they suggest that Tuxarin ER is safer than its competitors based on differences in dosing formulations and the safety profiles of individual ingredients.” The product contains codeine phosphate (an opiate agonist antitussive), and is associated with serious risks, OPDP states, such as respiratory depression and drug dependence.

The Web page also is problematic because it makes claims that “fail to adequately communicate the full approved indication for Tuxarin ER,” and because the company failed to submit the promotional material to the FDA accompanied by the Form FDA-2253, according to OPDP.

The OPDP asks both companies to cease misbranding their products, submit a written letter of response to the agency by Dec. 28, 2016, and include “a comprehensive plan of action to disseminate truthful, non-misleading and complete corrective message about the issues discussed in this letter” to the audiences that received the initial messages.