#regulatorycompliance
August 12, 2015 1:23 PM Subscribe
FDA issues warning over Kim Kardashian's drug promotions
The FDA's Office of Prescription Drug Promotion sent an official Warning Letter to Duchesnay, the marketer of Diclegis. The letter notes that while Diclegis is approved to treat pregnant women experiencing nausea and vomiting, "[Kardashian's] social media post is misleading because it presents various efficacy claims for DICLEGIS, but fails to communicate any risk information."
The letter also cites Duchesnay's past troubles in conveying risk, noting a previous warning from the FDA following the company's announcement of Diclegis' approval. The violative announcement "omitted all risk information and omitted material facts regarding DICLEGIS’ important limitation of use," such as the fact that Diclegis has not been tested or approved for hyperemesis gravidarum.
The FDA's Office of Prescription Drug Promotion sent an official Warning Letter to Duchesnay, the marketer of Diclegis. The letter notes that while Diclegis is approved to treat pregnant women experiencing nausea and vomiting, "[Kardashian's] social media post is misleading because it presents various efficacy claims for DICLEGIS, but fails to communicate any risk information."
The letter also cites Duchesnay's past troubles in conveying risk, noting a previous warning from the FDA following the company's announcement of Diclegis' approval. The violative announcement "omitted all risk information and omitted material facts regarding DICLEGIS’ important limitation of use," such as the fact that Diclegis has not been tested or approved for hyperemesis gravidarum.
Ugh. I know it's the FDA's job but pregnant women already fear any sort of anti-emetic being teratogenic after thalidomide.
posted by Talez at 1:49 PM on August 12, 2015
posted by Talez at 1:49 PM on August 12, 2015
There's a difference between how the FDA see drugs compared to the rest of us hoi polloi, since they have to write the official rules for their use. Physicians are completely within their right to prescribe Diclegis for HG as an "off-label" use if they have judged that it would provide more benefit than risk. The "off-label" though, literally means it is not a use the FDA has approved for the label (or package insert, really) based on evidence of safety and efficacy.
So I can sympathize with the FDA here, because most people aren't going make the fine distinction between morning sickness and HG, which means Kim K.'s post could lead to lots of women with HG asking their doctor's to prescribe a drug for off-label use, and specifically an off-label use which has not been studied. It's moving the individual decision of physician and patient into the public arena, which is tantamount to promoting a change in labeling without providing the data that such a change is safe and effective.
Also, I'm 110% certain that phrases like "there was no increased risk" sets FDA eyebrows twitching uncontrollably and induces heavy breathing.
posted by Panjandrum at 1:52 PM on August 12, 2015 [17 favorites]
So I can sympathize with the FDA here, because most people aren't going make the fine distinction between morning sickness and HG, which means Kim K.'s post could lead to lots of women with HG asking their doctor's to prescribe a drug for off-label use, and specifically an off-label use which has not been studied. It's moving the individual decision of physician and patient into the public arena, which is tantamount to promoting a change in labeling without providing the data that such a change is safe and effective.
Also, I'm 110% certain that phrases like "there was no increased risk" sets FDA eyebrows twitching uncontrollably and induces heavy breathing.
posted by Panjandrum at 1:52 PM on August 12, 2015 [17 favorites]
There is something just so damningly, brutally, helpful about the tone of FDA warning letters that makes them so chillingly effective at accomplishing their purpose. God bless the FDA, and thank God the grownups with muscle in the room work for us sometimes.
Cutsey Kardashian angle aside, don't be fooled, Duchesnay knew exactly what they were doing. There are whole sickly twisted and yet fabulously paid careers dedicated to finding ways to market bullshit the FDA won't allow in ways the FDA either can't or won't enforce. For example, a silly amount of medical news is written by marketers and then handed to reporters with deadlines not because the cost of advertising copy means anything but because journalists aren't bound by these rules.
posted by Blasdelb at 2:13 PM on August 12, 2015 [20 favorites]
Cutsey Kardashian angle aside, don't be fooled, Duchesnay knew exactly what they were doing. There are whole sickly twisted and yet fabulously paid careers dedicated to finding ways to market bullshit the FDA won't allow in ways the FDA either can't or won't enforce. For example, a silly amount of medical news is written by marketers and then handed to reporters with deadlines not because the cost of advertising copy means anything but because journalists aren't bound by these rules.
"...so I talked to my doctor."This the part where Kim Kardashian consciously attempts to limit her liability for the medical advice she is dispensing, I mean, who would ever say this outside of a drug commercial?
"He prescribed me #Diclegis, and I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby.”And this is the part where the marketing professionals who wrote this, as well as their lawyers, really fucked up by pissing on the bear they should be dancing around.
posted by Blasdelb at 2:13 PM on August 12, 2015 [20 favorites]
I say again: William Gibson is an optimist, at least when he talks about marketing.
posted by randomkeystrike at 2:22 PM on August 12, 2015 [5 favorites]
posted by randomkeystrike at 2:22 PM on August 12, 2015 [5 favorites]
Diclegis is a combination of pyridoxine (vitamin B6) and doxylamine, both of which have been available as cheap OTC drugs for a long, long time. There's no particular reason why anyone should pay for the branded combination.
Which is not to say that Duchesnay, the manufacturer, is offering nothing of value to the world with this drug. Clinical trials are extremely expensive to run, and the clinical trials for Diclegis demonstrate that the combination of pyridoxine and doxylamine is safe and effective in pregnant women. That's valuable (if unsurprising) information for medical science to have. That doesn't mean, however, that the individual patient is obligated to retroactively pay for it.
posted by dephlogisticated at 2:45 PM on August 12, 2015
Which is not to say that Duchesnay, the manufacturer, is offering nothing of value to the world with this drug. Clinical trials are extremely expensive to run, and the clinical trials for Diclegis demonstrate that the combination of pyridoxine and doxylamine is safe and effective in pregnant women. That's valuable (if unsurprising) information for medical science to have. That doesn't mean, however, that the individual patient is obligated to retroactively pay for it.
posted by dephlogisticated at 2:45 PM on August 12, 2015
There's no particular reason why anyone should pay for the branded combination.
Diclegis is a time release format of the two drugs. For whatever reason, it really helps. HG really threatens women's lives, and many women choose to have an abortion because of it, and so finding a drug combination and format that helps with that is amazing.
posted by hydropsyche at 3:29 PM on August 12, 2015 [1 favorite]
Diclegis is a time release format of the two drugs. For whatever reason, it really helps. HG really threatens women's lives, and many women choose to have an abortion because of it, and so finding a drug combination and format that helps with that is amazing.
posted by hydropsyche at 3:29 PM on August 12, 2015 [1 favorite]
Ugh. I know it's the FDA's job but pregnant women already fear any sort of anti-emetic being teratogenic after thalidomide.
Which should be an argument in favor of the FDA being really hard-assed, not more lenient. We have the FDA because companies want to sell medicines they make, and sick people want to buy them. Neither body really has an interest in making sure the medicines are safe for everybody, so we have a third-party to do so, and because profit and pain can both make people irrational, we make sure that third party is very strict.
posted by neonrev at 4:19 PM on August 12, 2015 [12 favorites]
Which should be an argument in favor of the FDA being really hard-assed, not more lenient. We have the FDA because companies want to sell medicines they make, and sick people want to buy them. Neither body really has an interest in making sure the medicines are safe for everybody, so we have a third-party to do so, and because profit and pain can both make people irrational, we make sure that third party is very strict.
posted by neonrev at 4:19 PM on August 12, 2015 [12 favorites]
Just to clarify: OBGYNs prescribe Diclegis to women with HG because it is one possible thing to try if the standard drug, Zofran, doesn't work. That has nothing to do with Kim Kardashian, and this ruling against Kardashian will not impact the ability of women who need the drug to get it. There are many many off-label uses of drugs that occur in situations when the approved drugs don't work. Bodies are different, and people who deviate from the norm still require treatment. People with a chronic or rare illness frequently have all kinds of stories about off-label uses.
posted by hydropsyche at 4:46 PM on August 12, 2015 [1 favorite]
posted by hydropsyche at 4:46 PM on August 12, 2015 [1 favorite]
The benefit of the time release formulation is primarily that it can be taken at bedtime and the time to peak concentration will roughly coincide with morning. Depending on severity of symptoms, a supplemental morning and afternoon dose may be necessary. If someone considers it to be worth $10-20/day, I say go for it. It may be worth considering a trial with the OTC products first, though.
The other thing your $10-20/day will buy you is the rare and shiny Pregnancy Category A designation, vs. Category B for OTC doxylamine. Same drug, but the specific dose and formulation has an official FDA baby-safe stamp of approval. There is likely no significant difference from a practical standpoint, but people get (rightfully) neurotic about drugs in pregancy, so the peace of mind may be worth the cost for some people.
posted by dephlogisticated at 4:47 PM on August 12, 2015
The other thing your $10-20/day will buy you is the rare and shiny Pregnancy Category A designation, vs. Category B for OTC doxylamine. Same drug, but the specific dose and formulation has an official FDA baby-safe stamp of approval. There is likely no significant difference from a practical standpoint, but people get (rightfully) neurotic about drugs in pregancy, so the peace of mind may be worth the cost for some people.
posted by dephlogisticated at 4:47 PM on August 12, 2015
The largest difference between the FBI and the FDA, is that the FDA sends you nice notes before they conduct a fully armed raid, arrest your executives, and shut down your company.
I kinda like the FDA.
posted by underflow at 6:16 PM on August 12, 2015 [1 favorite]
I kinda like the FDA.
posted by underflow at 6:16 PM on August 12, 2015 [1 favorite]
Which should be an argument in favor of the FDA being really hard-assed, not more lenient. We have the FDA because companies want to sell medicines they make, and sick people want to buy them. Neither body really has an interest in making sure the medicines are safe for everybody, so we have a third-party to do so, and because profit and pain can both make people irrational, we make sure that third party is very strict.
But the research has been done for decades on this combination, the drug is pregnancy cat A. It's prescribed for regular morning sickness. The FDA in this instance is being really, REALLY pedantic about possible off-label use.
posted by Talez at 8:03 PM on August 12, 2015
But the research has been done for decades on this combination, the drug is pregnancy cat A. It's prescribed for regular morning sickness. The FDA in this instance is being really, REALLY pedantic about possible off-label use.
posted by Talez at 8:03 PM on August 12, 2015
It's strange to have a conversation about how the FDA should be super strict in restricting Diclegis to proper on-label (is that a word?) use, because before Diclegis was available everybody just took Zofran. Which is not approved for morning sickness or for HG or for use in pregnancy, period.
posted by gerstle at 8:43 PM on August 12, 2015 [1 favorite]
posted by gerstle at 8:43 PM on August 12, 2015 [1 favorite]
Wait, everybody is still taking Zofran for morning sickness, right? I talked to a still-pregnant nurse practitioner who said she took it like 15 weeks ago. Has it fallen out of favor? It seemed to be the drug of choice when I was pregnant in 2011.
posted by purpleclover at 8:50 PM on August 12, 2015
posted by purpleclover at 8:50 PM on August 12, 2015
But the research has been done for decades on this combination, the drug is pregnancy cat A. It's prescribed for regular morning sickness. The FDA in this instance is being really, REALLY pedantic about possible off-label use.
From the point of view of someone in the industry, my interpretation is the FDA is being normally conscientious about off-label marketing. This is what they do, and (despite some recent court challenges) I think it's what they should do.
You need to include risks and contra-indications in the ads, and you can't make or imply things are true that you haven't had approved via the FDA process. The FDA won't stop doctors from prescribing things but they will stop companies from trying to peddle it specifically for that purpose
posted by mark k at 11:35 PM on August 12, 2015 [8 favorites]
From the point of view of someone in the industry, my interpretation is the FDA is being normally conscientious about off-label marketing. This is what they do, and (despite some recent court challenges) I think it's what they should do.
You need to include risks and contra-indications in the ads, and you can't make or imply things are true that you haven't had approved via the FDA process. The FDA won't stop doctors from prescribing things but they will stop companies from trying to peddle it specifically for that purpose
posted by mark k at 11:35 PM on August 12, 2015 [8 favorites]
Yes, sorry, purpleclover. I didn't phrase that well. I meant people on Diclegis would otherwise be taking Zofran, not that people don't take Zofran anymore.
posted by gerstle at 1:24 AM on August 13, 2015
posted by gerstle at 1:24 AM on August 13, 2015
But the research has been done for decades on this combination, the drug is pregnancy cat A. It's prescribed for regular morning sickness. The FDA in this instance is being really, REALLY pedantic about possible off-label use.
Seconding what Mark K said (except I work at a gas station and know nothing of anything.), but I'll also add that if it's very likely to be totally fine for the off-label use, then I can't see any reason they wouldn't go through whatever process there is to get it approved for that off-label use except avoiding spending money to do it legally. Decades of research is all well and good, but when I buy medicine I am damned happy there are some pedantic sons of bitches watching over it, and how it's advertised.
posted by neonrev at 2:48 AM on August 13, 2015
Seconding what Mark K said (except I work at a gas station and know nothing of anything.), but I'll also add that if it's very likely to be totally fine for the off-label use, then I can't see any reason they wouldn't go through whatever process there is to get it approved for that off-label use except avoiding spending money to do it legally. Decades of research is all well and good, but when I buy medicine I am damned happy there are some pedantic sons of bitches watching over it, and how it's advertised.
posted by neonrev at 2:48 AM on August 13, 2015
"...That doesn't mean, however, that the individual patient is obligated to retroactively pay for it."Paying for nice things is how we get nice things.
posted by Blasdelb at 3:37 AM on August 13, 2015
The FDA in this instance is being really, REALLY pedantic about possible off-label use.
They absolutely are not.
The FDA has two jobs with regards to prescription drugs. (1) They make sure drugs are safe and safely made. This is to prevent disasters like using diethylene glycol (antifreeze's more poisonous cousin) to dissolve meds in syrup for kids (which actually happened). (2) They make sure health claims are accurate. This is to prevent scammers from selling pills that contain a stimulant like cocaine and claiming it is a sleep aid (also actually happened).
A lot of people conflate these two missions but they are very separate. When it comes to the second mission, the best way to prevent fraud is by strict regulation of what sort of benefits a marketer can claim. A lot of it can seem like splitting hairs; But the grey zone is territory where unscrupulous marketers are experts at using implied messages and subtle product labeling to sell simple milk protein and a multivitamin as an expensive drug that makes surgery safer and aging slower (not only happened but is a fraud that the FDA stopped at a cost of millions of dollars to one of my father's employers)
If its that effective, it should be fairly easy to demonstrate this to the FDA
I wish.
About half of the drugs pediatricians use have no FDA approved labeling for children. Some drugs have almost miraculous benefits for some childhood diseases but lack FDA approval to list that disease as an indication. If a drug is off patent or otherwise old as dirt,* no one is really motivated by market forces to pay for all new expensive drug trials to get the new indication added to the labeling. This is especially true if the drug is already widely used for that indication by doctors.
Once a drug is on the market, FDA regulatory approved indications is only part of the information a prescriber will use in deciding what medicine to use. Much of the time small clinical trials published in a respected journal is the only thing needed to motivate thousands of doctors to consider prescribing an old drug for a new disease. And that's for healthy adults in the outpatient wellness check-up. In the hospital all bets are off depending on how sick someone is.
* My favorite case of this: the professional society of children's ears-nose-and-throat surgeons officially endorses a 50:50 mixture of alcohol and hydrogen peroxide as treatment for swimmer's ear. This is because there's a lot of personal experience and actual research that show's it's JUST AS EFFECTIVE as a $200 course of antibiotic ear drops. I do not imagine anyone applying for FDA approval for that "combo-drug" any time soon.
posted by midmarch snowman at 5:48 AM on August 13, 2015 [10 favorites]
They absolutely are not.
The FDA has two jobs with regards to prescription drugs. (1) They make sure drugs are safe and safely made. This is to prevent disasters like using diethylene glycol (antifreeze's more poisonous cousin) to dissolve meds in syrup for kids (which actually happened). (2) They make sure health claims are accurate. This is to prevent scammers from selling pills that contain a stimulant like cocaine and claiming it is a sleep aid (also actually happened).
A lot of people conflate these two missions but they are very separate. When it comes to the second mission, the best way to prevent fraud is by strict regulation of what sort of benefits a marketer can claim. A lot of it can seem like splitting hairs; But the grey zone is territory where unscrupulous marketers are experts at using implied messages and subtle product labeling to sell simple milk protein and a multivitamin as an expensive drug that makes surgery safer and aging slower (not only happened but is a fraud that the FDA stopped at a cost of millions of dollars to one of my father's employers)
If its that effective, it should be fairly easy to demonstrate this to the FDA
I wish.
About half of the drugs pediatricians use have no FDA approved labeling for children. Some drugs have almost miraculous benefits for some childhood diseases but lack FDA approval to list that disease as an indication. If a drug is off patent or otherwise old as dirt,* no one is really motivated by market forces to pay for all new expensive drug trials to get the new indication added to the labeling. This is especially true if the drug is already widely used for that indication by doctors.
Once a drug is on the market, FDA regulatory approved indications is only part of the information a prescriber will use in deciding what medicine to use. Much of the time small clinical trials published in a respected journal is the only thing needed to motivate thousands of doctors to consider prescribing an old drug for a new disease. And that's for healthy adults in the outpatient wellness check-up. In the hospital all bets are off depending on how sick someone is.
* My favorite case of this: the professional society of children's ears-nose-and-throat surgeons officially endorses a 50:50 mixture of alcohol and hydrogen peroxide as treatment for swimmer's ear. This is because there's a lot of personal experience and actual research that show's it's JUST AS EFFECTIVE as a $200 course of antibiotic ear drops. I do not imagine anyone applying for FDA approval for that "combo-drug" any time soon.
posted by midmarch snowman at 5:48 AM on August 13, 2015 [10 favorites]
Even if the FDA were totally fine with it, I still think it's gross for celebrities to be hawking drugs on social media.
posted by Monochrome at 7:16 AM on August 13, 2015 [1 favorite]
posted by Monochrome at 7:16 AM on August 13, 2015 [1 favorite]
So is the issue more the off label use?
posted by ridiculous at 10:02 AM on August 13, 2015
posted by ridiculous at 10:02 AM on August 13, 2015
Paying for nice things is how we get nice things.
I agree in principle. In practice, there is often little relationship between the medical utility of a drug and its price. Companies charge whatever they can get away with. Licensing and patent shenanigans for artifically limiting competition are common. Prices are distorted by the many, convoluted layers of the healthcare/reimbursement system. The cost of Drug X might be $6 or $600 depending on whether your insurance company was able to reach a deal with the manufacturer that year (add a 400% markup if you happen to receive the drug in a hospital). The money you pay might go towards developing the next breakthrough cancer treatment or it might be used to market a product for thickening eyelashes. Most likely it will be wasted on some very poorly-conceived mergers and acquisitions, the end result of which is an alarmingly dry pipeline and a series of layoffs (R&D is always the first to go).
The practice of obtaining new indications for old drugs can be particularly problematic. In the best case scenario, a company discovers a legitimately novel and useful application for an existing drug and are rightly compensated for demonstrating that it works (see: thalidomide for leprosy). In the worst case scenario, a company patents a widely known off-label use for a drug and jacks up the price simply because it can (see: colchicine).
I would put Diclegis somewhere in between. We've known for decades that pyridoxine and doxylamine help with morning sickness. Some people may find the combination/extended-release formulation to be useful. It's certainly nice to have solid data on safety in pregnancy--we need more of that in general. Is the net benefit to society enough to justify the price for the individual consumer? I definitely lean towards no, but that's just my two cents.
posted by dephlogisticated at 3:43 PM on August 13, 2015 [1 favorite]
I agree in principle. In practice, there is often little relationship between the medical utility of a drug and its price. Companies charge whatever they can get away with. Licensing and patent shenanigans for artifically limiting competition are common. Prices are distorted by the many, convoluted layers of the healthcare/reimbursement system. The cost of Drug X might be $6 or $600 depending on whether your insurance company was able to reach a deal with the manufacturer that year (add a 400% markup if you happen to receive the drug in a hospital). The money you pay might go towards developing the next breakthrough cancer treatment or it might be used to market a product for thickening eyelashes. Most likely it will be wasted on some very poorly-conceived mergers and acquisitions, the end result of which is an alarmingly dry pipeline and a series of layoffs (R&D is always the first to go).
The practice of obtaining new indications for old drugs can be particularly problematic. In the best case scenario, a company discovers a legitimately novel and useful application for an existing drug and are rightly compensated for demonstrating that it works (see: thalidomide for leprosy). In the worst case scenario, a company patents a widely known off-label use for a drug and jacks up the price simply because it can (see: colchicine).
I would put Diclegis somewhere in between. We've known for decades that pyridoxine and doxylamine help with morning sickness. Some people may find the combination/extended-release formulation to be useful. It's certainly nice to have solid data on safety in pregnancy--we need more of that in general. Is the net benefit to society enough to justify the price for the individual consumer? I definitely lean towards no, but that's just my two cents.
posted by dephlogisticated at 3:43 PM on August 13, 2015 [1 favorite]
The issues are (in order of decreasing importance):
- You simply can't claim benefit without talking about risks. Ever. Even if the most common risk is something innocuous like "being sleepy" which is this drug's main side effect, you better explicitly mention it. Duchesnay got a nasty-gram from the FDA for similar behavior in 2012.
- The FDA is trying to be vigilant about social media advertising. Norms of communication and marketing aren't well established in social media so the FDA errors on the side of caution. This is consistent with the whole philosophy of the FDA's support for Direct-to-Consumer advertising. Specifically, the FDA is willing to allow or even encourage direct advertising in the hopes this industry money will increase public health literacy and refine our understanding of health communication. But, there's not much public health communication that can be achieved with 144 characters. If the marketing isn't doing anything to promote health education, the FDA has less incentive to support it.
One example: Let's say I post on Facebook "Zofran is the best drug ever, it made me taller." Now let's say the company that makes Zofran has a Facebook page and that page "liked" my comment. The FDA would be right pissed about this because the company's resources are being used to support my B.S. claim about an anti-nausea pill making me taller. Doesn't matter that "likes" are stupid and I wasn't paid. This communication, as abstract as it is, isn't supporting public health education and is supporting claims of benefit. It gets shot down.
- The final issue is the failure to add the disclaimer that Diclegis isn't "on-label" indicated for Hyperemesis. I honestly have no idea why the FDA is repeatedly making this point. I'd guess this goes way back to some guidance in the original trial design not being followed, or some discussion between the gov and Duchesnay leading to FDA approval. Usually the FDA has a good reason for requiring disclaimers about specific off-label use. I've noticed these disclaimers when a company has previously gotten in trouble for borderline fraud.
posted by midmarch snowman at 5:42 AM on August 14, 2015
- You simply can't claim benefit without talking about risks. Ever. Even if the most common risk is something innocuous like "being sleepy" which is this drug's main side effect, you better explicitly mention it. Duchesnay got a nasty-gram from the FDA for similar behavior in 2012.
- The FDA is trying to be vigilant about social media advertising. Norms of communication and marketing aren't well established in social media so the FDA errors on the side of caution. This is consistent with the whole philosophy of the FDA's support for Direct-to-Consumer advertising. Specifically, the FDA is willing to allow or even encourage direct advertising in the hopes this industry money will increase public health literacy and refine our understanding of health communication. But, there's not much public health communication that can be achieved with 144 characters. If the marketing isn't doing anything to promote health education, the FDA has less incentive to support it.
One example: Let's say I post on Facebook "Zofran is the best drug ever, it made me taller." Now let's say the company that makes Zofran has a Facebook page and that page "liked" my comment. The FDA would be right pissed about this because the company's resources are being used to support my B.S. claim about an anti-nausea pill making me taller. Doesn't matter that "likes" are stupid and I wasn't paid. This communication, as abstract as it is, isn't supporting public health education and is supporting claims of benefit. It gets shot down.
- The final issue is the failure to add the disclaimer that Diclegis isn't "on-label" indicated for Hyperemesis. I honestly have no idea why the FDA is repeatedly making this point. I'd guess this goes way back to some guidance in the original trial design not being followed, or some discussion between the gov and Duchesnay leading to FDA approval. Usually the FDA has a good reason for requiring disclaimers about specific off-label use. I've noticed these disclaimers when a company has previously gotten in trouble for borderline fraud.
posted by midmarch snowman at 5:42 AM on August 14, 2015
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posted by hydropsyche at 1:28 PM on August 12, 2015