According to The Legal Times, state attorneys general are looking closely at the Food and Drug Administration’s (FDA) warning letters on direct-to-consumer advertising (DTC) and other advertising as a source for new cases against pharmaceutical and device manufacturers.
The FDA letters are being used both as evidence in lawsuits alleging unfair advertising practices and as a road map for attorneys general to pursue cases.
The most recent case, the YAZ case with Bayer Healthcare, 27 attorneys general got Bayer to agree to run $20 million in advertising to correct exaggerated drug claims.
The attorneys general consider FDA warning letters as the “best evidence you can get” and that “FDA warning letters have served as a trigger for many attorneys general investigations.” FDA warning letters are not the only source of information required to open an investigation.
The attorneys general cite several cases that have recently been settled by state attorneys general including:
West Virginia vs. Johnson & Johnson $4.5million
Connecticut vs. Cephalon $6.0 million
State of Florida vs. Merck over Vioxx DTC Yet to be settled
Pharmaceutical companies are not sitting back. According to Sir Ramaswami, a spokesperson for Jansen J&J, “We have well-established, strictly enforced marketing and promotion policies to ensure that our products are only promoted for their FDA-approved indications.”
Companies need to take these very public warnings by the FDA very seriously and diligently review all their marketing with the eye of an FDA reviewer and/or State Attorney General.
The Legal Times: States Take Aim at Deceptive Drug Ads