Pharmaguy's Insights Into Drug Industry News
194.6K views | +4 today
Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
Curated by Pharma Guy
Your new post is loading...
Your new post is loading...
Scooped by Pharma Guy!

Public Citizen: Off-Label Uses Promoted in DTC Ads for Diabetes Drugs

Public Citizen: Off-Label Uses Promoted in DTC Ads for Diabetes Drugs | Pharmaguy's Insights Into Drug Industry News |

Public Citizen, a consumer advocacy group with more than 350,000 members and supporters nationwide, sent FDA’s OPDP Director Tom Abrams a letter on March 31, 2015 urging him “to stop the apparently violative off-labelpromotional statements in the direct-to-consumer (DTC) advertisements of five prescription drugs approved for the treatment of Type 2 diabetes. The drugs are Farxiga (dapagliflozin), Jardiance (empagliflozin), Invokana (canagliflozin), Victoza (liraglutide) and Bydureon (extended-release eventide).”

Usually, pharmaceutical companies are accused of promoting drugs “off-label” to physicians, which is understandable because it is perfectly legal for physicians to prescribe drugs for so-called off-label use.

The FDA rarely cites off-label or “unapproved use” claims made in DTC ads. None of the letters issued by FDA in 2014 mentioned that violation. Historically (between 2004 and 2013), only 4% of violations cited in FDA letters was concerned with off-label/unapproved use promotion and no TV ad received such a letter (see here).

Public Citizen includes a Farxiga ad that “touts” weight loss and blood pressure reduction as potential benefits although the drug has not been approved for those indications (see the ad in the above figure; also included is a screen save from the TC ad).

“These five drugs have been approved solely to lower hemoglobin A1C levels in patients with Type 2 diabetes,” says Public Citizen, “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.”

Public Citizen wonders if the FDA approves on such off-label ads and asks a couple of interesting questions in light of the recent paucity of warning letters issued by the FDA (read “Banging Year for Drug Approvals, Wimpy Year for Enforcement Actions”).

Read more here.

No comment yet.
Scooped by Pharma Guy!

Are #Pharma Brand drug Names Designed to Inform or to Confuse?

Are #Pharma Brand drug Names Designed to Inform or to Confuse? | Pharmaguy's Insights Into Drug Industry News |

Apparently, the branding of prescription pharmaceuticals is close to rocket science in complexity. The FDA has veto power over the monikers attached to all brand-name prescription drugs sold in the United States. (Generic drug names, which are often even more bizarre than their brand-name counterparts, go through a different and much more complicated approval process.)

When considering a brand name for approval, FDA reviewers run tests to see how likely it is that a proposed name could be mistaken for an already existing drug with a similar-sounding or similar-looking name. They do tests to catch names that might look alike when scribbled out on a prescription pad in the inscrutable handwriting of physicians.

They also reject any names that could be seen as a boast about the drug’s power or efficacy, which is why you won’t see any drugs named Cholesterol Busters, or Angina-B-Gone (too bad, I’d love to see a commercial for that one).

The net result of all this intense regulatory scrutiny is written in the bizarre names of those prescription drugs in the marketplace. The profusion of really strange names leaves consumers in a quandary. As one prominent medical professor put it, “Pharmaceutical product naming is designed to confuse, not to inform.”

We are truly blessed by all the drugs out there. They are expensive to develop, expensive to test, expensive to market, and sometimes very expensive to produce, but often they make our lives better or at least more bearable.

However, when it comes naming these products, I would suggest to the FDA that “simpler is better and simplest is best.” Sadly, all too often it seems the drug names can be much more complex and exotic than the disease itself.

Pharma Guy's insight:

I must admit that some names like farxiga are not only confusing, but darn near impossible to pronounce. I think the DTC commercials on TV for this product should come up with a nifty way to help consumers remember how pronounce the name -- like this video by Boehringer that helped me learn how to pronounce its name: How DO You Pronounce "Boehringer Ingelheim"? After all, if the goal is to get the consumer to ask their patient for the drug, they should know how to pronounce it. I've seen the commercial several times, and still am not sure of the proper pronunciation.

No comment yet.