Those who closely track so-called "Untitled Letters" authored and sent by the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) know the letters most frequently reference promotions made over two types of media: the Internet and print media.
But in an unusual letter sent last week by OPDP, the office indicated that it's still keeping an eye on promotions made using a decidedly traditional format: the telephone.
An Untitled Letter
In its 7 July 2014 Untitled Letter* to OptumInsight Life Sciences—the US agent for Concordia Pharmaceuticals—FDA alleges that a professional telephone script used by the company to market its extended-released Kapvay tablets is "false or misleading" due to its alleged omission of risks and other material facts.
The drug is FDA-approved to treat attention deficit hyperactive disorder (ADHD), but has a long list of warnings on its label, including that it can cause patients to become sleepy, dizzy, develop upper respiratory tract infections, and can cause withdrawal symptoms.
The problem, according to FDA: OptumInsight's script was "completely" devoid of some of the drug's risks, including contraindications, warnings, precautions and common adverse reactions.
No ‘One-Click’ for Phone Calls
While FDA noted that the script included "a general statement about adverse events" and a statement that full prescribing information would be emailed to the person being spoken to, FDA maintained that the statement "does not mitigate the omission of the important risk information."
Just like FDA doesn't seem to recognize a "one-click" rule on the Internet, neither does it recognize a "one-email" rule for phone conversations, either.
The letter goes on to also chide the company for failing to include information from the drug's label, and also for failing to disclose the drug's established (i.e. non-branded) name, clonidine hydrochloride. The latter is a violation of 21 CFR 202.1(b)(1), FDA explained.
Concordia and OptumInsight were asked by FDA to immediately stop using the phone script to market Kapvay, and to write a response to FDA indicating its intent to comply with FDA's Untitled Letter.
Untitled Letter on Kapvay
*Untitled Letters—unlike Warning Letters—do not threaten immediate enforcement action if a company fails to comply with a letter, but instead generally indicate FDA's feeling that an advertisement or action falls afoul of federal regulations.