Class of One - Avoiding Warning Letters, Part II

According to FDA regulations, one cannot state a claim that one's drug or biologic is superior to another unless there has been a head to head study demonstrating that superiority. That regulatory reality can be frustrating to communications professionals who market drugs. There may be times when a marketer might be tempted to try to sidestep that constraint, by making a claim of superiority regarding a new class of drugs, but without mentioning the specific drug or biologic product by name. This is especially tempting if the drug they are wanting to market is the only approved drug in its class.

It doesn't work.

The FDA will most certainly issue a warning letter whether or not the drug or biologic is mentioned by name if a claim of superiority is assigned to the class where there is only one approved product. They have done it in the past, and in this era when the agency is trying to shore up confidence in its ability to regulate the pharmaceutical industry, they most surely would do it again.

Comments

[QAGuru]

Interesting posting. You have referenced FDA Warning Letters and there is a site you might find interesting: http://www.compliancedoc.com/

All of their content (FDA Warning Letters and Regulations) are searchable text!