FDA Declares An Exhibit Booth False & Misleading
18 CommentsBy Ed Silverman // December 15th, 2011 // 8:11 am
Generally, drugmakers that run afoul of the FDA for violating regulations about marketing will be scolded for their advertisements or handouts to doctors. But how about an entire exhibit booth at a medical convention? This is what happened to NeurogesX, which last June was promoting its Qutenza treament for neuropathic pain associated with postherpetic neuralgia.
At issue was a promotional panel for the drug on display at the booth at the American Academy of Nurse Practitioners meeting that was held in Las Vegas. The panel, which made various effectiveness claims, was clearly visible to anyone who walked by, but there was a small problem - the risk information was not visible to viewers, at least as a practical matter, according to the FDA.
To be specific, the risk info was noted at the bottom of the display panels, but this was apparently obscured by bags, boxes and other stuff. This meant the safety info was inaccessible to those who stopped or walked by. As a result, the FDA deemed the entire booth to be false or misleading for presenting efficacy claims, but not risk info, according to an untitled letter written on December 13.
How did the FDA know? Well, the obscured panel was seen by three different personnel from the FDA Office of Prescription Drug Promotion, each of whom viewed the booth separately at three separate times. In other words, there was ample opportunity for NeurogesX employees to move the stuff, but they apparently never bothered (here is the letter and here is the panel).
Of course, this may have been a simple instance of carelessness, not a sneaky way to hide risks. But the point the FDA is trying to make is that entire exhibit booths require diligence. As the agency wrote “…the exhibit booth presentation misleadingly suggested that Qutenza is safer than has been demonstrated by substantial evidence or substantial clinical experience.” Besides, boxes and bags belong under or behind tables. Who wants to spend all that money on a booth that looks a mess?
xtian
So instead of asking the booth attendants to move the bags and boxes so that the safety information was displayed, three separate FDA personnel took that information back to their office, and instead wrote a letter? If an action to remedy a situation is easily correctable to prevent dissemination of “misleading information” to the consumer, wouldn’t it be prudent to have the agency take that immediate action? No so. It appears that the agency would rather not take action, and let the “misleading information” be in public all day. Then admonish the company later by writing a letter about the event, which had circumstances that may not happen again (i.e, their next booth might not be so messy as the article implies). If the priorities were the protection of the consumer, why didn’t the FDA personnel ask the booth attendants to “clean up” their area? Please educate me.
John F.
Xtian,
Very well stated. I couldn’t have said it any better. I feel the same way about the FDA’s action or inaction in this matter. They could have taken immediate action. Consumers may have walked away that very same day with a false sense of security.
John
mika
there was enough white space to raise the ISI info. This was a an obvious attempt by the company to disregard guidance on placement. Im with OPDP, not thier job to cleaan or fix pharma mess..
Pharma MarketingGuy & Proud of It
This is a perfect example of FDA skullduggery at its finest. Of course the easiest thing to do would have been for FDA officials to identify themselves and to ask that the obscuring material be moved. But alas, no, they won’t reveal their secret identies as G-men so that they can preserve their veil of secrecy.
The real problem is one of training. The sales trainers for the company should have schooled the reps on how to spot FDA’ers at a drug company exhibit:
1) they tend to travel alone, as opposed to doctors, who like to schmmooze while checking out the exhibits.
2) they spend more than the usual 30 seconds at a booth and/or make repeat visits.
3) they always carry empty tchochke bags, hence no potential for conflicts of interest. However, they alwaays go for our frozen custard.
4) they sometimes take notes at an exhibit, which nobody else ever does.
5) when talking to a booth rep they always seem to be looking the other way.
6) they tend towards retro ties and sport jackets.
7) they never ask for your business card unless they are secretly trying to escape the rathole otherwise known as “The Agency”.
8) Most of all, They NEVER crack a smile.
The G-Men are usually dead giveaways, hence I fault the training dept on this one.
Joleen Chambers
Proud “pharma marketing guy” fits a stereotype, too. Perhaps he should be retrained to have some respect for the diversity of objectives at play in the issue of marketing pharmaceuticals with integrity. The FDA does have a difficult mission made more difficult by snarky comments.
snarktooth
Lighten up, Joleen. It’s just a blog, not War and Peace.
FormerFDAer
Moving the bags etc away from the risk info would not have fixed the problem. Probably why FDA didn’t make that request. If you look at the panels, the risk info presentation is ridiculously less prominent than efficacy claims, leading to the lack of fair balance.
In my experience, most FDAers don’t have the motives some of you are ascribing to them. They are doing their job. No excuse for this company not to know the regs and current FDA thinking. No one could argue that panel fairly showed the risks and benefits.
xtian
FDAer
Your post is a great example of the true issue - the subjective nature of how rules are applied. In your eyes, “the risk info presentation is ridiculously less prominent than efficacy claims, leading to the lack of fair balance.” In my eyes (disclaimer: I don’t know, work for, have any ties to this company or drug) I see lots of “safety” information on the bottom, a polar bear and a Drug name. But to my eyes, that “safety information” is the “legal stuff that all companies have to put in their ads because of the gov’t.” I equate it with the disclaimer read so fast at the end/beginning or car commercials, or the “fine print” on the advertisements for Comcast cable. This legal language is trumpeted as important, but in reality, I feel that there are really no consequences to me if it weren’t in the ad.
I still have to go to a Doc to ask for the drug. (In fact, after viewing this ad, I would probably ask for the drug with the polar bear on it?!) Even after asking the Doc, I still trust that my Doc’s will use his professionalism and his knowledge about all medicines to tell me: “No, that’s not what you need,” or “No, I can’t give you that drug because you are already on drug Y and they interact.”
I read a study somewhere that reported a typical consumer comprehends at a 12th grade level, so even if this safety information was more prevalent, typical consumers will not understand it (it is not written at a 12th grade level) and either become desensitized to it or ignore it altogether.
Heck, I don’t even know what PHN pain is and why red lighting is striking that poor polar bear!
reg affairs guy
xtian, I doubt there are any 12th grade readers at these exhibits save for the bimbos that demonstrate the latest in cardio exercise testing (as well as a few reps working the booths).
Having served on compliance committees for 20 years I never saw a proposed booth exhibit come to my attention because you can’t simulate a booth in a written piece. They are usually assembled on site by a contractor, and the only way I would ever get to inspect such an exhibit is if my companies would fly me to the meeting for this single task. They never approved these requests because we, nor any of my industry colleeagus ever received an NOV for a booth exhibit as far as I am aware.
I don’t blame my companies for not spending the tens of thousands of dollars they would have spent over a 20 year period to send me on such visits to meetings based on the rare possibility that we might get nailed by an FDAer. In those cases we take our lumps and move on. No big deal at all IMO.
harpy
FDA skullduggery? ha! yeah, those big, bad agents tricked that poor little pharma into violating labeling rules. here, I have a very tiny violin for you.
harpy
also:
“The average readability of American state and federal Web sites is at the eleventh-grade level, well above the comprehension level of many Americans. According to national literacy statistics, half of Americans read at the eighth-grade level or lower.”
CreativeDirector
Wait a minute. The purpose of a medical convention panel is to entice a DOCTOR to ask about the drug. It is not a stand-alone informational brochure. Thus this is really a non-issue. The biggest mistake the drug company made was putting all that copy in there to begin with, taking it away from it’s job as a billboard. But the FDA workers should have asked the Reps to move the bags, and I’m pretty sure they would have! And, to the point of reading level, I believe Doctors generally read above 12th grade level, and cannot be compared to the “general population” in this regard.
Mad Man
Creative Director, you are right, that was the original purpose of the booth: minimal copy, maximal talk. However that was in ther days when many reps were paharmacists and were comfortable talking science at length while staying on message. Unfortunately today’s reps manning the booths are mostly the same reps that haunt the offices, onlly with a few more brownie points.
These reps only know how to speak in 2 minute sound bites, not the kind of dialogue you are referring to. The trend in recent years has been for fewer reps to man the booths, thus fewer chances to go off script. Mostly what you get these days are the Barbies with the pearly white chiclets handing out reprints like the way the stewardesses used to hand out magazines when you boarded an airplane, while at the same time taking your order for a made-on-the-spot ice cream sundae with your favorite flavor. The sundae takes about two minutes to make, so that it is conveniently ready by the time the rep has exhausted her complete store of product knowlege.
Hemorrhoid Surgery
I can kind of see both sides of the argument here. The FDA should have just talked to the people and corrected the problem instead of letting it go and writing a long report. At the same time the booth people should have been educated in the first place. It shouldn’t have ever have been an issue.
John Osborne, MD
But wait a minute! Don”t forget that this product is simply pharmaceutical capsaicin! It’s just expensive Tabbasco Sauce! Just don’t get the stuff in your eyes, and you are good! I’m so glad to see that the FDA is keeping us safe from the perils of inappropriate Hot Sauce use!
Patrick
A better action would be to tell the booth staff to move the stuff and then go back to the office and write the letter.
therep
Mad Man
Many reps are completely capable of having intelligent scientific conversations about the products. Unfortunately, due to the heightened regulation by the FDA reps are not allowed to do things as simple as have a discussion about information inside the PI of products. Therefore they tend to speak in 2 minutes sound bites since they are not allowed to have an intelligent conversation due to the potential for speaking off label.
Former Pharma Insider
The numerous posts from all sides are indicative of the larger issue - the lack of real communication and partnership between the companies and agency. Perhaps if both sides talked with each other rather than at each other, we might see some progress.