Boca Raton Lawyer Blog

FDA generally send warning letter to various health care pharmaceuticals if found any misleading advertising through DTC (Direct-To-Customer) broadcast. It is really important each laboratory must understand the risks associated with any wrong information or misleading suggestion brought into public.

Any type of promotional message through TV ads should be demonstrated by substantial evidence or substantial clinical experience to minimize the risks and side effects.  As reported from FDA warning letters in various lawsuits, inadequate caution about potential side effects may lead to strokes, heart attacks, gallbladder disease, deep vein thrombosis, pulmonary embolism, cardiac arrhythmias and sudden death also.

Let us cite an instance where a New Jersey based laboratory because of its misleading efficacy and safety presentations received a FDA warning letter from Department of Health &Human services. The division of Drug Marketing, Advertising and Communications (DDMAC) identified those tablets (composition of Drospirenone/ Ethinyl Estradiol) which carried misleading information and violated Federal Food, drug and cosmetic act.  The misleading ad minimized important risk information that must be conveyed to the patients. There were superiority claims in the ad message that distinguished the tablet from other combination oral contraceptives. Even the ad-tagline too can give illusive ideas.

Most importantly if there is any drug comparison done during the ad display; it must be backed up by substantial evidence or clinical experience. In general, FDA is not aware of any evidence demonstrating which is superior or beneficial to whom. Rather they are more concerned about the clinical risks associated with the drug. Thus the major objective of such warning letter is creating significant public health and safety concerns among US people.

Whom to contact:

An established lawyer who had a prior experience of dealing with FDA Warning Letter