False Marketing Prompts FDA to Warn to Drug Manufacturers | Shapiro, Washburn & Sharp

The Wall Street Journal has reported that the U.S. Food and Drug Administration has issued warnings to the makers and marketeers of high blood pressure medication Adcirca (tadalafil) for issuing marketing materials containing misleading information.

In the United States, United Therapeutics markets and develops Adcirca. Eli Lilly & Co. markets and develops the product outside of America. Both companies received warning letters from the FDA about the misinformation and misrepresentation. 

According to the FDA, Adcirca’s website overstates the effectiveness of the drug and also fails to detail all possible complications of taking the drug, such as cardiovascular problems among other things. Failure to produce accurate and whole information misleads consumers and makes Adcirca seem safer to take than it actually is. 

A recent study published by the Journal of Bioethical Inquiry notes that the practices of “cherry-picking” clinical trial results to align with marketing agendas, suppressing information and misrepresenting or spinning information have been around for decades and are still very common today’s pharmaceutical world. The authors of the study, Glen Spielmans and Peter Parry, refer to the aforementioned practices as “marketing-based medicine.”  

According to the report, Lilly, one of the manufacturers of Adcirca, has participated in some of the aforementioned unethical practices. While the study focuses primarily on the misrepresentation of antipsychotics, marketing-based medicine is a practice that is used in the promotion of various medications.  

The WSJ reported that United Therapeutics has now removed content that the FDA cited as misleading from its website. For some users of this drug however this correction may have come too late.

Patient trust is often abused by drug manufacturers.
As patients, we expect the medicine we take to make us better, not worse. When drug companies misrepresent facts or withhold information about dangerous side effects, it is the patient who is left to suffer. In some cases, side effects of prescription medication can be long lasting or even fatal.

Our law firm has handled several cases concerning drug safety. If you have experienced adverse side effects from prescription medication, contact our law firm for a free consultation and learn your legal options today.