See a need, fill a need
October 22, 2015 7:07 PM Subscribe
In the wake of Turing/Martin Shkreli's 5000x price hike of Daraprim, reaction sets in regarding the need for reasonable prices on FDA-generic drugs.
As the furor over Martin Shkreli's 5000x price-hike of Daraprim continues (previously), people are doing something about it.
Imprimis, a compounding pharmacy, has stepped in to fill the gap by offering the AIDS drug for $99/100 pills and has spun off a division to start doing the same for other sole-source FDA-approved generics.
As the furor over Martin Shkreli's 5000x price-hike of Daraprim continues (previously), people are doing something about it.
Imprimis, a compounding pharmacy, has stepped in to fill the gap by offering the AIDS drug for $99/100 pills and has spun off a division to start doing the same for other sole-source FDA-approved generics.
"This is not the first time a sole supply generic drug – especially one that has been approved for use as long as Daraprim – has had its price increased suddenly and to a level that may make it unaffordable."-- Mark Baum, Imprimis CEO
And what happened then? Well, in Whoville they say that eriko's small heart grew three sizes that day.
posted by eriko at 7:20 PM on October 22, 2015 [16 favorites]
posted by eriko at 7:20 PM on October 22, 2015 [16 favorites]
Nicely done, Imprimis.
posted by Artw at 7:21 PM on October 22, 2015 [3 favorites]
posted by Artw at 7:21 PM on October 22, 2015 [3 favorites]
Great news! I'm happy to see they're going to do this for other sole-source generics. Imprimis just got a lot of good press for not trying to gouge consumers. I hope other companies take note.
posted by angelchrys at 7:32 PM on October 22, 2015 [6 favorites]
posted by angelchrys at 7:32 PM on October 22, 2015 [6 favorites]
Doing the right thing instead of trying to gouge people for all the money you can get? Why, that's downright un-American!
posted by SansPoint at 7:40 PM on October 22, 2015 [7 favorites]
posted by SansPoint at 7:40 PM on October 22, 2015 [7 favorites]
IMMY on NASDAQ, if you're wondering, as I was.
posted by birdsquared at 7:51 PM on October 22, 2015 [3 favorites]
posted by birdsquared at 7:51 PM on October 22, 2015 [3 favorites]
So, how, exactly, does a non-FDA-approved med get to the patient? I'm assuming the med can't be stocked down at your local CVS. Does it come straight from the compounding pharmacy (i.e. Imprimis) to the individual?
posted by Thorzdad at 7:58 PM on October 22, 2015 [3 favorites]
posted by Thorzdad at 7:58 PM on October 22, 2015 [3 favorites]
Good.
One key part of Shkreli's scam was that, by controlling the sole supply of the approved drug, no one else could easily run even the small clinical trial (a "bioequivalence study") needed for approval because you couldn't compare your version to theirs and prove it was the same. I was wondering Imprimis they not only got around that, but even if they could how they could get to market so quickly.
Apparently by selling it as a "custom" formulation, not the same "drug" (technically speaking):
I'm curious what the FDA will do. I'm certain "nothing to stop this" is the short term answer but there may be potential long term issues. Or maybe not. Maybe inspection of the compounding facility is good enough to prevent snake oil peddlers from trying this, and it puts a cap how much you can exploit the generics market.
posted by mark k at 7:59 PM on October 22, 2015 [11 favorites]
One key part of Shkreli's scam was that, by controlling the sole supply of the approved drug, no one else could easily run even the small clinical trial (a "bioequivalence study") needed for approval because you couldn't compare your version to theirs and prove it was the same. I was wondering Imprimis they not only got around that, but even if they could how they could get to market so quickly.
Apparently by selling it as a "custom" formulation, not the same "drug" (technically speaking):
There's a limitation, Baum said: The formulation is not FDA-approved, and can legally only be sold through a doctor's prescription to a specific individual. The specific ingredients are FDA-approved, Baum said, and its compounding operations are FDA-inspected.So IIUC officially it's your doctor's judgment that this is a treatment that will help you rather, and asking Imprimis to create it to order, rather than a genuine 'product' (again, technically.)
Filing for FDA approval of the compound itself would take years and millions of dollars, Baum said. By not filing, Imprimis can keep prices down and make a significant profit, even for less than $1 a capsule, Baum said in a Thursday interview.
I'm curious what the FDA will do. I'm certain "nothing to stop this" is the short term answer but there may be potential long term issues. Or maybe not. Maybe inspection of the compounding facility is good enough to prevent snake oil peddlers from trying this, and it puts a cap how much you can exploit the generics market.
posted by mark k at 7:59 PM on October 22, 2015 [11 favorites]
Aren't compounding pharmacies notoriously under-supervised anyway?
posted by phearlez at 8:14 PM on October 22, 2015 [3 favorites]
posted by phearlez at 8:14 PM on October 22, 2015 [3 favorites]
Tangentially related from my friend's twitter:
posted by raihan_ at 8:48 PM on October 22, 2015 [4 favorites]
My Halloween costume this year is Martin Shkreli
•pharmaceutical jacket
•At The Drive In t-shirt
•wrist cast
•talk shit to people on twitter
posted by raihan_ at 8:48 PM on October 22, 2015 [4 favorites]
The reverse settlement payments are also keeping generics off the market -- basically a patent holder pays competitors millions of dollars not to enter the market. Somehow this is not yet considered wholly illegal collusion, though hopefully the tide may be turning.
posted by RobotVoodooPower at 9:02 PM on October 22, 2015 [8 favorites]
posted by RobotVoodooPower at 9:02 PM on October 22, 2015 [8 favorites]
Compounding pharmacies are awesome. The three I've dealt with have all been very careful. My local place actually sent a sympathy card after my cat died (it was his medication that I was having made there).
I'm so glad this could be a reasonable option for people who need it.
posted by monopas at 12:24 AM on October 23, 2015 [3 favorites]
I'm so glad this could be a reasonable option for people who need it.
posted by monopas at 12:24 AM on October 23, 2015 [3 favorites]
What's the range of possible karmic repercussions for wishing financial ruin on somebody? Just hypothetically, you understand.p
FWIW, I have wished so much ill will on this human leech that I'm pretty sure I've created a black hole of karmic repercussion so large it will probably absorb any that might be meant for you.
posted by Room 641-A at 1:25 AM on October 23, 2015 [2 favorites]
FWIW, I have wished so much ill will on this human leech that I'm pretty sure I've created a black hole of karmic repercussion so large it will probably absorb any that might be meant for you.
posted by Room 641-A at 1:25 AM on October 23, 2015 [2 favorites]
you couldn't compare your version to theirs and prove it was the same.
This is why §112 of the US patent statute requires the applicant to provide "written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention."
In other words, if you want to be able to protect the FDA approved formulation with a patent you have to reveal the FDA approved formulation (i.e., the best mode) in the patent "in such full, clear, concise, and exact terms as to enable any person... to make and use the same."
That's one of the basic tradeoffs of the patent monopoly - inventors get a patent for a limited time only if they agree to share with the public everything the public needs to know to make and use the invention after the patent expires.
If the FDA is helping applicants to conceal this information (approving a patented formulation which has not been revealed in the patent) from the public that would be a terrible scandal.
posted by three blind mice at 2:54 AM on October 23, 2015 [3 favorites]
This is why §112 of the US patent statute requires the applicant to provide "written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention."
In other words, if you want to be able to protect the FDA approved formulation with a patent you have to reveal the FDA approved formulation (i.e., the best mode) in the patent "in such full, clear, concise, and exact terms as to enable any person... to make and use the same."
That's one of the basic tradeoffs of the patent monopoly - inventors get a patent for a limited time only if they agree to share with the public everything the public needs to know to make and use the invention after the patent expires.
If the FDA is helping applicants to conceal this information (approving a patented formulation which has not been revealed in the patent) from the public that would be a terrible scandal.
posted by three blind mice at 2:54 AM on October 23, 2015 [3 favorites]
Shkradenfreude: the joy of seeing a predatory scheme utterly demolished.
posted by acb at 3:09 AM on October 23, 2015 [6 favorites]
posted by acb at 3:09 AM on October 23, 2015 [6 favorites]
It's ironic that the head of Turing was so easily proved to be a heartless machine.
posted by dances_with_sneetches at 3:48 AM on October 23, 2015 [6 favorites]
posted by dances_with_sneetches at 3:48 AM on October 23, 2015 [6 favorites]
Or, you know, we could just abolish patents and get rid of all of this good-price / bad-price moralizing as the only (very weak) check we have against drug price gouging.
posted by Noisy Pink Bubbles at 4:35 AM on October 23, 2015 [7 favorites]
posted by Noisy Pink Bubbles at 4:35 AM on October 23, 2015 [7 favorites]
, if you want to be able to protect the FDA approved formulation with a patent you have to reveal the FDA approved formulation (i.e., the best mode) in the patent
That has never been true. For one thing, it is usually the case that a patent is applied for and granted prior to FDA approval. And it's especially not true now, since the America Invents Act largely eliminated the best mode requirement.
a patented formulation which has not been revealed in the patent
This is a contradiction in terms. "Patented formulation" by definition means that the formulation is described in the (publicly accessible) patent.
But more to the point, the FDA Orange Book lists all of the approved drugs in the US and the patents that cover them.
posted by jedicus at 6:53 AM on October 23, 2015 [1 favorite]
That has never been true. For one thing, it is usually the case that a patent is applied for and granted prior to FDA approval. And it's especially not true now, since the America Invents Act largely eliminated the best mode requirement.
a patented formulation which has not been revealed in the patent
This is a contradiction in terms. "Patented formulation" by definition means that the formulation is described in the (publicly accessible) patent.
But more to the point, the FDA Orange Book lists all of the approved drugs in the US and the patents that cover them.
posted by jedicus at 6:53 AM on October 23, 2015 [1 favorite]
Aren't compounding pharmacies notoriously under-supervised anyway?
Somewhat. A number of them are very, very good. And given the rage of combining existing generics into a patentable name brand, I'm all for compounding.
posted by eriko at 7:34 AM on October 23, 2015
Somewhat. A number of them are very, very good. And given the rage of combining existing generics into a patentable name brand, I'm all for compounding.
posted by eriko at 7:34 AM on October 23, 2015
@ThreeBlindMice:
In other words, if you want to be able to protect the FDA approved formulation with a patent you have to reveal the FDA approved formulation (i.e., the best mode) in the patent "in such full, clear, concise, and exact terms as to enable any person... to make and use the same."
The protection comes not from the patent but from the right to market given by FDA approval, which is completely different. You are under no obligation to even patent a formulation; indeed, AFAIK many patented drugs have formulations that aren't patented on account of being obvious ("mix with excipients, press into tablet shape.")
What the FDA has is a rule saying that if you want to manufacture and sell a drug you need to prove it's safe and effective. If nothing is protected by IP anyone can go through the process. The FDA won't stop you to protect others--in some cases they'll encourage others to enter the market. But you can't just say "I read the patent and did what was described, so now I can sell it." The FDA does not accept a belief in your own competence as proof, so human trials follow.
With novel drugs, the human trials are long and expensive. You need to dose enough people for long enough to prove it helps the disease and does not cause safety effects. Traditionally at least three trials of increasing length and size.
With generics, there's a shortcut--dose a human with it, and show your formulation (whether identical or not--that doesn't matter) gives the same levels in the patient as the approved drug that went through the long trials. This is much, much easier, and meant to encourage generics to enter the market.* The only problem is that if I can't get the supply of the original drug I can't run this same study and I'm back to square one. The option is to run a long trial that, if I'm competent, is highly likely to work based on no-longer-secret information like the patent, but I still have to do the trial.
Which is why Imprimis is taking another route: making the drug (which they know how to do, as nothing is "secret") but finding an option to technically avoid approval.
*In biologics treatments, like antibodies, this path is not really open and they basically never get competition.
posted by mark k at 8:04 AM on October 23, 2015 [3 favorites]
In other words, if you want to be able to protect the FDA approved formulation with a patent you have to reveal the FDA approved formulation (i.e., the best mode) in the patent "in such full, clear, concise, and exact terms as to enable any person... to make and use the same."
The protection comes not from the patent but from the right to market given by FDA approval, which is completely different. You are under no obligation to even patent a formulation; indeed, AFAIK many patented drugs have formulations that aren't patented on account of being obvious ("mix with excipients, press into tablet shape.")
What the FDA has is a rule saying that if you want to manufacture and sell a drug you need to prove it's safe and effective. If nothing is protected by IP anyone can go through the process. The FDA won't stop you to protect others--in some cases they'll encourage others to enter the market. But you can't just say "I read the patent and did what was described, so now I can sell it." The FDA does not accept a belief in your own competence as proof, so human trials follow.
With novel drugs, the human trials are long and expensive. You need to dose enough people for long enough to prove it helps the disease and does not cause safety effects. Traditionally at least three trials of increasing length and size.
With generics, there's a shortcut--dose a human with it, and show your formulation (whether identical or not--that doesn't matter) gives the same levels in the patient as the approved drug that went through the long trials. This is much, much easier, and meant to encourage generics to enter the market.* The only problem is that if I can't get the supply of the original drug I can't run this same study and I'm back to square one. The option is to run a long trial that, if I'm competent, is highly likely to work based on no-longer-secret information like the patent, but I still have to do the trial.
Which is why Imprimis is taking another route: making the drug (which they know how to do, as nothing is "secret") but finding an option to technically avoid approval.
*In biologics treatments, like antibodies, this path is not really open and they basically never get competition.
posted by mark k at 8:04 AM on October 23, 2015 [3 favorites]
I have no reason to think they're not mostly good, as is the case with most people anyway. But in the last decade we had a big issue with compounding pharmacies spreading some sort of contaminants. I am on mobile so I can't look for it right this moment.
posted by phearlez at 8:09 AM on October 23, 2015
posted by phearlez at 8:09 AM on October 23, 2015
Thing is - Shkreli is a symptom, not the disease. He's a mere cog.
It's good - perhaps as a symptom he will help us take this issue to the doctors and get it fixed. But the hate for Shkreli as an individual as if he's not part of the Capitalist machinery and corporate logic of profit taken to its logical conclusion is a bit silly. Hate on him, sure, but let's not act as though he's more than what he is - a pustulent boil on the flesh of the modern pharmaceutical monstrosity.
posted by symbioid at 12:34 PM on October 23, 2015 [1 favorite]
It's good - perhaps as a symptom he will help us take this issue to the doctors and get it fixed. But the hate for Shkreli as an individual as if he's not part of the Capitalist machinery and corporate logic of profit taken to its logical conclusion is a bit silly. Hate on him, sure, but let's not act as though he's more than what he is - a pustulent boil on the flesh of the modern pharmaceutical monstrosity.
posted by symbioid at 12:34 PM on October 23, 2015 [1 favorite]
big issue with compounding pharmacies spreading some sort of contaminants
Those were pharmacies compounding IV meds, which have to be far more sterile than oral meds. You know when your pharmacist takes a bottle of amoxicillin powder, adds a couple ounces of water, and shakes up the solution? That's compounding. So even if they end up doing this on a pretty large scale, it's quite low risk.
posted by selfmedicating at 7:13 PM on October 23, 2015
Those were pharmacies compounding IV meds, which have to be far more sterile than oral meds. You know when your pharmacist takes a bottle of amoxicillin powder, adds a couple ounces of water, and shakes up the solution? That's compounding. So even if they end up doing this on a pretty large scale, it's quite low risk.
posted by selfmedicating at 7:13 PM on October 23, 2015
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