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.”
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 that the drugs have been deemed safe and effective for weight loss and/or reducing blood pressure. In addition, all five drugs have serious toxicities, including hypotension, urinary tract infections, yeast infections (Farxiga, Jardiance, and Invokana), bladder cancer (Farxiga), pancreatitis, thyroid C-cell tumors (Victoza and Bydureon), and renal impairment (all five drugs).
Public Citizen’s letter demands a number of answers from FDA:
- Has FDA reviewed and approved the advertisements prior to, or since, their release?
- If not, what is the agency’s position on the weight-loss claims, as well as the blood-pressure-reduction claims for Farxiga and Invokana, made in the advertisements?
- If the agency did review and approve the advertisements, what was its rationale for allowing the inclusion of the weight-loss and blood-pressure-reduction claims?
- Has the FDA approved similar off-label efficacy claims in other DTC advertisements?
- If so, did these approvals result from a formal policy allowing such off-label efficacy claims in pharmaceutical DTC advertisements?
“We urge you to immediately issue Warning Letters requiring the manufacturers to withdraw these and any other advertisements containing similar off-label promotional statements,” Public Citizen concludes. Unfortunately…we must note here that the FDA’s enforcement of misleading drug marketing (both DTC and physician-targeted materials) has fallen far short in recent years.” They state that in 2014, “only 10 Warning and Untitled letters were issued to pharmaceutical companies for violative DTC and physician-targeted prescription drug ads, the fewest number since at least 1997. This was the culmination of a steady decline in such letters during Margaret Hamburg’s tenure, from a high of just 51 in 2010 to 31 in 2011, 28 in 2012, and 24 in 2013.”
It will be interesting to follow FDA’s response to this citizen’s petition, including any subsequent warning letters they release related to Type 2 diabetes ads.