After Quiet Quarter, OPDP Releases New Untitled Letter for Familiar Reasons

Regulatory NewsRegulatory News | 15 May 2014 |  By 

For the first time in nearly three months, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has released a new Untitled Letter, this time alleging that a company's printed sales aid is misleading in that it does not adequately communicate the risks of the product.

The 6 May 2014 Untitled Letter—a type of warning which alleges deviations from FDA's advertising standards, but does not threaten disciplinary action—is addressed to Alvogen, a pharmaceutical company whose sales aid for disulfiram tablets caught the eye of FDA.

Disulfiram, more commonly known by the brand name Antabuse, is used by patients to treat alcoholism by inducing an undesirable physical reaction when alcohol comes into contact with the drug.

FDA said it took issue with a "new product release" promotion distributed by Alvogen which announces the product's introduction into the market and briefly notes that it is "an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety."

Most of the advertisement, however, is focused on the product's physical packaging attributes, which are described as supporting "pharmacy efficiency and filing accuracy" and coming in "flexible" alternatives based on the needs of each individual pharmacy.

New Untitled Letter

For FDA, however, the inclusion of the product's intended medical use—the treatment of alcoholism—and its product category ("alcohol antagonist") without also listing risk information renders the sales aid "misleading" under its policy of requiring fair balance of benefits and risks in all drug promotions.

"By omitting the most serious and frequently occurring risks associated with disulfiram, the sales aid misleadingly suggests that disulfiram is safer than has been demonstrated," FDA claimed.

In addition, OPDP claimed that the sales aid omitted "material fact[s]" by failing to include that the drug is, "not a cure for alcoholism" and is generally less effective when used absent other supportive measures like therapy.

FDA requested that the company immediately stop distributing the advertisement.

Focus has reached out to Alvogen for comment but had not heard back at the time this article was published.

Untitled Letter to Alvogen

Sales Aid


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