A recent article in MM&M highlighted how warning letters (found here) sent by the Food and Drug Administration’s (FDA) Division of Drug Marketing, Advertising, and Communications (DDMAC) could double in 2010.
In fact, it was noted that “FDA letter-writers have already been prolific in 2010 on themes of risk omission, inflated efficacy claims, and unfair balance presentation as seen in promotional materials targeting physicians and consumers.” In fact, DDMAC has already sent out 40 enforcement letters – 30 Untitled Letters and 10 Warning Letters – in 2010, compared with a total of 41 enforcement letters – 28 Untitled Letters and 13 Warning Letters – in all of 2009, according to Karen Mahoney, an FDA spokesperson. The 2010 number thus far is also substantially greater than the 21 enforcement letters DDMAC sent in 2008, 11 of which were Warning Letters.
According to Ayse Yeaton, an FDA spokesperson, “the increase in the number of regulatory letters are the result of DDMAC putting more resources into enforcement, and the FDA Enforcement Initiative announced by Commissioner [Margaret] Hamburg” last August. What has also led to the increase in letters according to Yeaton is that “the agency has also streamlined its review process for regulatory letters,” making it more efficient for DDMAC to stop more misleading promotion.”
MM&M explained how “typically, Warning Letters are more severe than Untitled Letters, although both types usually ask that recipients immediately cease the dissemination of violative promotional materials.” In addition, since 2005, Warning Letters have also requested “corrective” messaging from advertisers, or “a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed,” to be sent to any “audience(s) that received the violative promotional materials.”
In response to the increase of letters, Arnold Friede, an FDA legal expert and former attorney at Pfizer, said “People [in the pharmaceutical industry] aren’t paying attention to these letters. He further added that we are “seeing repeated instances of the same kinds of violations,” such as non-disclosure of risk information and unsubstantiated efficacy claims.
Since companies are making the same mistake, Friede asked “how far up against the wall industry will push the FDA before [increasingly severe] actions are taken.” He equated the problems to the fact that companies are either “not paying attention, or they’re not absorbing the lessons in the letters.”
Perhaps there is a need for more education between companies and the FDA/DDMAC to help clarify the expectations and regulations regarding marketing and advertisements.
It is important that companies take these letters very seriously as we reported last year State Attorney Generals are well aware of these letters and using them as a basis for state actions.
Before companies find themselves facing significant administrative burdens that keep their products off the market and patients uninformed, there needs to be a better dialogue about these problems, not just one way letters.