FDA Urged to Fine Drugmakers Over Ads

Public Citizen sent a letter to the drug promotion overseer at the Food and Drug Administration urging it to pull ads for five Type 2 diabetes drugs because it claims the ads promote benefits that have not been approved by the agency. The watchdog group is also asking the FDA to fine the drug companies for violating rules governing off-label marketing, a move it says the agency has never made.

The drugs it cites are Farxiga (dapagliflozin), made by AstraZeneca & Bristol-Myers Squibb; Jardiance (empagliflozin), manufactured by Boehringer Ingelheim; Invokana (canagliflozin) made by Janssen Pharmaceuticals; Victoza (liraglutide) made by Novo Nordisk and Bydureon (extended-release exenatide) manufactured by Amylin.

Public Citizen’s letter was sent to the FDA’s Office of Prescription Drug Promotion. The companies have not yet responded to it (see here: http://www.citizen.org/hrg2250 and here: http://www.citizen.org/documents/2250.pdf). The watchdog group says the ads appear in magazines, on the drugmakers’ websites, and for some like Farxiga, in TV commercials.

It says in its letter that “the deliberate placement of the (weight loss) claims in such close proximity to the drugs’ approved indications serves to reinforce this impression,” that these side benefits are legitimate. Public Citizen adds that blood pressure reduction is touted as “a potential benefit,” an “especially egregious ‘benefit’ claim, as hypotension is listed as an adverse effect in the medications’ labels.”

Public Citizen says in fact “low blood pressure is a major side effect” for two drugs (Farxiga and Invokana), adding in a statement “other side effects of the five drugs include urinary tract infections, yeast infections (Farxiga, Jardiance and Invokana), bladder cancer (Farxiga), pancreatitis, thyroid C-cell tumors (Victoza and Bydureon) and kidney failure (all five drugs).”

Dr. Sammy Almashat, researcher with Public Citizen’s Health Research Group, said in a statement: “The FDA is clearly asleep at the wheel in regulating the marketing of often dangerous pharmaceuticals to the public.” The doctor adds: “When companies can engage in such off-label promotion with no consequences, it virtually guarantees that such marketing to patients and physicians alike will continue unabated.”

To get the drug manufacturers’ to pull their ads, Public Citizen says the FDA must issue warning letters to them. But it notes that the agency’s “issuance of such letters has fallen sharply in recent years, from an average of 111 such letters sent per year from 1997-2001, to just 29 per year from 2010-2014.”

Moreover, it says “the FDA has never fined a pharmaceutical company for unlawfully misleading drug ads, despite having the authority to do so since the 2007 Food and Drug Administration Amendments Act.”