False and Misleading or Just Messy?

When it comes to marketing and promotion, most pharmaceutical companies play by the FDA rules. Violations result in Warning Letters. And Warning Letters are not good. Period.

To avoid such violations, drug companies have introduced promotional review committees and other measures to keep marketers on the straight and narrow.   Additionally, they’ve hired Compliance Officers, regulatory staff and legal counsel.  Now it seems, pharma may have to add house-keeping to the mix!

Last summer, NeurogesX, a San Francisco-based biopharmaceutical company exhibited at the American Academy of Nurse Practitioners meeting in Las Vegas to promote Qutenza  – a capcaisin treatment for neuropathic pain associated with postherpetic neuralgia; a condition that occurs as a result of nerve damage after an outbreak of shingles.

The NeurogesX exhibit included an eye-catching promotional panel for Qutenza featuring a polar bear. The panel made various effectiveness claims, and included all the risk and safety claims required by the FDA.  So, what’s the problem?

Well, according to a Warning Letter sent to the company the risk information was inaccessible to those who stopped or walked by because it was obscured by bags, boxes and other stuff! As a result, the FDA deemed the entire booth to be false or misleading.

How did the FDA know? Well, apparently three different personnel from the FDA Office of Prescription Drug Promotion, visited the booth separately at three different times, meaning this was not a one-off occurrence.

So, was this a simple case of carelessness or was NeurogesX trying to hide the risk information? I’m not sure we’ll ever know the truth, but it’s clear the FDA is “cleaning house” – one exhibit booth at a time.

Was the Agency justified?  If they really care about safety why didn’t they say something at the time, rather than let the boxes obscure the data throughout the show?  Let us know what you think.

FDA launches BadAd campaign

Stethoscope? Check. White Coat? Check. Whistle? Pardon!!!

Citing a limited ability to identify violative pharmaceutical advertising and promotional activities, the FDA has announced the launch of its “Bad Ad” Program.  The Program encourages health care prescribers to directly report false and / or misleading drug advertising, marketing materials and promotional activities to the FDA – specifically activities that:

  • omit or downplay the risks of a drug
  • overstate the effectiveness of a drug
  • promote off-label uses
  • compare drugs in a misleading manner

In addition  to asking doctors to whistle-blow on violations that occur during speaker programs, sales presentations, TV, radio & print advertisements, websites and print materials the FDA wants doctors to “monitor promotional activities that occur in private.”

FDA is particularly interested in what pharma reps say during sales calls, presentations, discussions at medical conferences, and in other face-to-face interactions.

Health care professionals who encounter suspect claims or activities are asked to notify the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC). As part of the program, the FDA will offer physicians training at medical conferences on how to identify misleading sales aides. In addition, the agency has simplified the reporting process which now includes a hotline and email address.  Submissions may be anonymous.

DDMAC enforcement activity has  risen dramatically over the past year, and the “Bad Ad” Program suggests that FDA hopes to take even more enforcement action in the future.  The issue of concern here is whether by directly engaging the help of doctors as informal enforcement agents, the FDA is creating an “us against them” culture – where “us” is FDA and doctors, and “them” is the pharmaceutical industry.

While Word on Health is all for marketing compliance we wonder if doctors will  answer the call.   Do they have the time to be on the  look-out for bad ads?  Will they want to engage in time consuming activities for which there is no reimbursement? And do they want to be seen as the “enforcers?”

But assuming they will, SRxA can help guide you through the complex world of marketing compliance. We can help you deliver non-violative information to physicians. Contact us today for more information.