Inside the FDA: Why The Pfizer, Inc. (PFE) Boxed Warning On Chantix Is Unlikely To Be Removed

Qualitative measurements are extremely difficult to quantify, especially in such a large series of studies like this. The whole initiative may have been doomed from the start. Categorizing mental phenomena as severe or mild from one person to another who may both have totally different ideas as to what is what and what the definitions of relevant terms are, is almost impossible to do effectively.

There are other issues cited by various sources that may also further motivate the FDA to maintain the label as is, including not wanting to set a precedent for successful removal of a label like this on the basis of poorly collected data. This is also an issue, but not the primary one in our opinion. The central issue is the FDA’s reputation.

Finally, may we say this: The FDA is a regulatory bureaucratic body. It operates based on strict rules and guidelines set for it by Congress and it never wants to make a pure “judgment call” if it can avoid doing so for fear that its judgment call may be slightly off and it will be blamed for something. There are no regulatory guidelines for the removal of a boxed warning. Says the FDA (emphasis ours):

THERE IS NO SPECIFIC REGULATION OR GUIDANCE THAT HAS BEEN ESTABLISHED TO REMOVE A BOXED WARNING. HOWEVER, IF THE CRITERIA FOR INCLUDING A BOXED WARNING ARE NO LONGER MET, IT IS REASONABLE TO REMOVE IT.

Even if it is “reasonable” to remove it, it is also “reasonable” to retain it. The FDA probably will not risk its reputation for the sake of being “reasonable”. If there is no regulation or specific guidance to remove a boxed warning, with data collection problems like these and the potential for seriously bad press if the label is removed and something bad happens – and something bad will eventually happen, even if it takes years to happen – you can bet that the FDA will not remove this label. Reword it slightly, maybe, but remove it? The chances are 10% at best, regardless of the technical majority vote by the joint advisory panel on September 14.

Note: This article is written by David Rich and was originally published at Market Exclusive.