Public Citizen Urges FDA To Penalize Drug Makers Over Diabetes Ads, Criticizes the Agency’s “Dismal Record” on Issuing Warning Letters

Consumer advocacy group Public Citizen is calling on the Food and Drug Administration (FDA) to “stop the apparently violative off-label promotional statements” in various Type 2 Diabetes advertisements, which the group argues are being advertised as weight-loss drugs. “[N]one of the drugs is approved for weight loss and, despite the presence of disclaimers that the medications are not weight-loss drugs, the implication is clearly that weight loss is an additional potential benefit of the drugs,” Public Citizen states. This request comes in the midst of a “drastic reduction” in the past few years of direct-to-consumer (DTC) ads cited by the FDA in Warning and Untitled letters sent to pharmaceutical companies, notes Public Citizen. “Between 1997 and 2001, the earliest five-year period for which data are publicly available, the agency sent an average of 111 such letters per year, while an average of only 29 letters per year were sent during the most recent five-year period, 2010 through 2014.” View the full letter from Public Citizen to Tom Abrams, Director of the Office of Prescription Drug Promotion at FDA, here.  The diabetes drugs named by Public Citizen are Farxiga, Jardiance, Invokana, Victoza, and Bydureon. Their letter to  These five drugs have been approved solely to lower hemoglobin A1C levels in patients with Type 2 diabetes, but the advertisements presented in this letter clearly convey the false perception to patients and doctors th...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs