FDA Warns Sanofi-Aventis Over Misleading Material
12 CommentsBy Ed Silverman // October 28th, 2009 // 7:28 am
The agency sent a warning letter to the drug maker for distributing “misleading” promotional material for its Uroxatral medication for urinary problems caused by an enlarged prostate. The problem was a promotional card touting the benefits of Uroxatral on the front, but some important stuff -risks, proper use of the med and folks who shouldn’t take it - only showed up on the back of the card. Tricky, yes?
The FDA wrote the card is designed to be adhered to a flat surface, such as a pharmacy counter, “and as a practical matter, viewers of the front side of the card are unlikely to be able to view the back side of the card once it is stuck in place.” The agency called this insufficient to ensure claims on each part of the card are “truthful and non-misleading,” and added that Sanofi-Aventis couldn’t fix the problem by including this phrase: “please see important safety information on back.”
The front of the card contains the phrases, “Always in the bathroom … especially at night?” and “Relief begins with U.” The FDA said those phrases in the absence of specific use info could misleadingly encourage usage in circumstances other than those for which the drug has been shown to be safe and effective, such as for overactive bladder.
Uroxatral is only approved to treat signs and symptoms of benign prostatic hyperplasia, or enlarged prostate, and should be used with caution in patients with liver or kidney impairment, among other contraindications, according to the product’s approved label, Reuters adds. As Reuters notes, Uroxatral is a relatively small product for Sanofi with US sales last year of about $176 million. The drug maker is figuring out what to do next and says the card was mostly placed in doctor offices.
Justice in Michigan
I read this and I would genuinely, sincerely like to know how folks from industry read this?
Small potatoes? Oversight? Improper conduct?Just part of “the game”?
In the scheme of things, I don’t see it as a “big deal.” But, for outsiders, it inevitably gets filed as some version of an example of “there they go again.”
Are outsiders missing the point?
Compliance Analyst
If it were a GMP warning, it would carry much more weight. It seems at times that DDMAC hands out warning letters like candy, which to me kind of kills the seriousness of getting a warning letter.
Did they do it on purpose? Probably not, but they should know better. I think that DTC should really be DTD (direct to doctor). It really makes more sense. But then reps need to have to find the time to get in to see docs….good luck.
Justice in Michigan
Thanks, Compliance Analyst.
There was a time, not long ago, when DDMAC wasn’t doing much, no?
Re: DTD, isn’t that still the vast majority of promotional budget, not just via reps but in other communications? Perhaps this has changed. I recall it dwarfing DTC (budgetwise) a few years ago.
Christopher
JiM - Re DTD spending: yes the majority of promotional budgets is spent reaching doctors and other practitioners, just using different media and channels than before. At the same time as reps are finding it harder (impossible) to see docs, an increasing number of docs are using other means to get info, most frequently digital media. That’s where the money is going.
Christopher
ps And I would not be surprised to see less DTC the way we see it now ie TV and print.
Justice in Michigan
This is a somewhat…tangential question, but in a school (university) newspaper I recently perused, there were four quarter-page ads on four consecutive pages. Each one invoked the dangers of genital warts and HPV infection (although the c word was never used) and advised female college students to go to the university health services and talk it over.
None of the print ads mentioned Gardasil. Only the last of the ads included the word “Merck,” at the bottom.
Does the definition of “reminder ads” include such situations, when even the company that bought the ads need not be identified?
Justice in Michigan
I see these would now be under the rubric of “help-seeking ads,” and appear to be within bounds. A student of mind did, indeed, go to health services and was specifically encouraged to get the Gardasil vaccination. This was within the past month. She was given a flier that was created in 2006 (according to the info on it), a couple of months after Gardasil was approved. It was identified as coming from the CDC and was labeled as an “interim” document.
Jaynesday
Justice,
This incident is minor but kind of symbolic of in the sense that critical information was hidden. On purpose? I don’t know, but from companies that we rightfully expect the pentacle of professionalism and performance, it appears that in far too many cases we have more along the lines of road side fruit stands.
So here is where this outsider truly stands concerning drugs and devices and their manufacturers.
If the day comes that I am prescribed a drug or device –
I will not take the advice of my doctor (who may be misinformed or bought off) without extensive personal research.
I will consider the product label likely to have as much disinformation or missing information than truth.
I will consult the FDA’s adverse event database knowing that many events go unreported.
I will even consider the FDA’s approval of the product as something to question.
I will disregard information provided by medical publications as they may only be advertising written by the product’s manufacturer.
I will consider the reputation and past practices of the pharmaceutical company that provides the product.
I will scour the internet to find out what the experiences of others have been with the suggested drug or device. This I will consider to be the most reputable information available.
Most importantly -
I will continue to take care of my health in an effort to remain as drug free as possible thereby “boycotting” I could care less pharmaceutical companies.
Obviously I do not trust them and intent to not put myself in a position that I must rely on them.
I will also advise all of my family and friends to do the same.
Have I missed the point? I hope someone can convince me that I have.
Wow!
Jaynesday–I think that’s a pretty good list. And it is obviously sad for all of us to have to think/act this way. (Of course, most people won’t–because of time, inclination, etc.)
In the meantime, what do we do when we’re going into surgery and are unlikely (I think) to request a list of the various devices, instruments, and drugs that might be part of the procedure?
That’s why I think working with docs we trust and respect is a critical piece. It does not solve all, perhaps not even most, of what your responding to. But it helps.
cliffintokyo
wow: “docs we trust and respect”
Now there’s a thought.
In the USA? I regret to say I have serious doubts. Aren’t they (nearly) all queuing up out of med school to do nose jobs and knee surgery on wealthy private insurance patients (instead of treating sick people) because it pays 100x better?
I might be more inclined to believe my hard-pressed but (relatively) honest health service doc who follows his solemn oath to ‘do no harm’
MJ RIP.
Compliance Analyst
JiM, I agree for a while DDMAC wasn’t doing a whole lot, but when warning letters are sent to cereal companies (see Cheerios) I start to question if warning letters aren’t being diluted.
Re: My comment about DTD and DTC spending While I am far from the marketing or sales arena (I do compliance for manufacturing), as a consumer, I think the money would be better spent on clinical trials, R&D, and lifecycle maintenance of the product. I would rather see the DTC ad money spent on trade material like medical journals (though I am sure they already spend a lot of money there as well).
P.S. I am waiting for a warning letter because I claim eating a balanced diet and exercising could help your lower weight and cholesterol in most populations. :D
Justice in Michigan
Compliance Analyst–Fully concur. Look out about saying much about diet and exercise. But at least you didn’t mention the “c” word….
Cheerios.