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Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by pravda on Wednesday November 28, 2018 @12:16PM (#18553334)
Why would the price be any lower?

If it costs $12.53 to manufacture an EpiPen equivalent, and the market price of the EpiPen is $300, it would make no sense to sell it for any price other then $300.

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by mythrowaway1124 on Wednesday November 28, 2018 @12:22PM (#18553383)
You're assuming your conclusion.

Why should the market price be $300? If it only costs $12.53 to manufacture, someone could sell epipen equivalents for much less than $300 and capture the whole market.

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by skksjsnaahs on Wednesday November 28, 2018 @12:28PM (#18553444)
Suppose there are only two competitors and the barrier to entry for a third is high. You profit $287.47 per unit with partial market share. If you try to charge $200 so you only make $187.47 per unit, your competitor will also lower the price to $200 and you will both end up with the same market share but less profit. Even if the two participants in the market never communicate, the obvious strategy in a two-player game is keep the high price.
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by mattnewton on Wednesday November 28, 2018 @12:34PM (#18553527)
This works when there are two people (who can maybe even use the same golf resorts), but it’s impractical when there are 10 or more since anyone has a temporary advantage to defect. That’s how free markets are supposed to work and I think people might expect that to happen here. It’s just that, as you noted, with only two particiants allowed in the market, forming a cartel is trivial.
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by jonlucc on Wednesday November 28, 2018 @01:01PM (#18553875)
That's true because it's not trivial to launch a new drug/delivery system. Even generics have to prove that their drug matches the kinetics of the patent drug and has other similar properties. There is still an FDA process to approving a new drug, and if I'm not mistaken, the new delivery device also has to have it's own approval through the FDA medical devices division.

All of that is before you even take into account how much it costs to re-tool your production line to make something different. Sure, you could lower the barriers to entry until they're barely existent and offer almost no consumer protection, but I'm not really sure we want to make it so easy that a company will spin up a production line to make a drug for 6 months while they think they can undercut the competition.

Then again, I'm a big pharma biologist, so I probably am a bit biased toward safety and large, slow movements.

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by mattnewton on Wednesday November 28, 2018 @01:15PM (#18554043)
A solution to this particular problem could be to make the patents on the existing, known to be safe methods expire earlier, so that in order to retain a monopoly on something big pharma must make a significant patentable improvement.

Critics of this policy say that it would disincentive new drug development. That may be true, but for many people it doesn’t matter because they can’t afford them at current monopoly rates anyways, and our insurance industry is broken for them.

I wonder how you would go about researching a better patent-expiration scheme and the effects it would have.

Edit: maybe I misunderstood you- are you saying even with no patent protection, the barrier to entry is still high enough to disincentivize new entrants because of safety regulation and retooling costs? So patents aren’t the only roadblock, or not even necessarily the main roadblock?

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by jonlucc on Wednesday November 28, 2018 @02:05PM (#18554570)
I mean what you say in your edit. Even off-patent drugs require basic proof that they are what they claim to be, are similar to the patent drug in important ways, have a safe formulation, require a company to make a production line for it, and even require some marketing in many cases to make sure people know there's a new manufacturer of that drug.

I've never worked in generics, so I'm certainly not an expert, but I am saying both that we need some of the safety and quality controls by the FDA (or some system to replace them without relying on companies' good will) and that there are big hurdles even disregarding the FDA or other regulatory bodies.

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by Someone on Wednesday November 28, 2018 @02:29PM (#18554792)
”Even if the two participants in the market never communicate”

But you can’t get at identical prices without communication between parties. Without communication, initial price setting is as if both companies make a bid in a sealed envelope.

It would be highly unlikely that both bids would be identical, and the lowest bidder with a price above $12.53 makes all the profit.

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by saint_fiasco on Wednesday November 28, 2018 @03:07PM (#18555145)
The two participants didn't appear at the same time. When the first participant appeared and set the original price, that price became an obvious Schelling point.
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by gamblor956 on Wednesday November 28, 2018 @12:55PM (#18553798)
No, it's more like this: I'm the CEO of a medical drug supply company. I want a new yacht, or a new Jetstream private plane, or hell--why choose between them when I can get both? What price should I charge for a drug millions of people need each year so that I can continue to enable my decadent lifestyle?

If the historical price is X, but I can charge 4X because people need the drug, let's charge 5X so I can make even more profit because demand is inelastic.

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by DaiPlusPlus on Wednesday November 28, 2018 @01:44PM (#18554334)
And the bad PR of news reports of people dying because they can’t afford our lifesaving products can be addressed by issuing a press release announcing price cuts and a coupon program which will both be ended after the public moral outrage dies down.
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by hpbd on Wednesday November 28, 2018 @01:48PM (#18554380)
People like to believe bad PR kills companies because that makes them think they have control over their lives. Poor bastards...
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by antisthenes on Wednesday November 28, 2018 @12:34PM (#18553524)
> Even if the two participants in the market never communicate, the obvious strategy in a two-player game is keep the high price.

No, it isn't. The default strategy is not collusion. It's lowering the price to capture more of the market.

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by philipov on Wednesday November 28, 2018 @12:40PM (#18553595)
One should be hesitant to proclaim knowledge of the optimal strategy without knowing all the details. Whether or not the default strategy is to cooperate or betray is sensitive to the precise weights of the rewards for each combination of decisions, as well as the number of times the game is played. For example, in the simple version of the Iterated Prisoner's Dilemma, the optimal strategy is tit-for-tat: the default is to cooperate, and only betray in exchange for being betrayed.
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by cortesoft on Wednesday November 28, 2018 @01:26PM (#18554148)
I mean, that really isn't the default strategy. As Adam Smith recognized in Wealth of Nations, the default strategy is always to collude:

"People of the same trade seldom meet together, even for merriment and diversion, but the conversation ends in a conspiracy against the public, or in some contrivance to raise prices."

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by chimeracoder on Wednesday November 28, 2018 @01:41PM (#18554299)
> As Adam Smith recognized in Wealth of Nations, the default strategy is always to collude:

That's a misreading of Smith's point, but it's also irrelevant here, because it's quite a leap to assert that "the default strategy is to engage in blatantly illegal activity".

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by pessimizer on Wednesday November 28, 2018 @02:31PM (#18554816)
No, it's not a leap, it's why the activity is illegal: to artificially raise the cost of the default strategy.
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by chimeracoder on Wednesday November 28, 2018 @04:15PM (#18555767)
> No, it's not a leap, it's why the activity is illegal: to artificially raise the cost of the default strategy.

Collusion is illegal because it harms consumers, not because collusion is the "default strategy".

In fact, collusion is not the default strategy simply because it is not stable in the long term; there's a lot of research which demonstrates this.

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by philipov on Wednesday November 28, 2018 @05:14PM (#18556179)
If it were not the favorable strategy, it wouldn't have to be illegal, because it would not be popular enough to hurt consumers. People habitually favor optimizing for short-term success because there is no long-term if you don't survive the short-term. Furthermore, it is actually repeated interaction that makes collusion/cooperation better than betraying, because of the opportunity to get punished on subsequent iterations. It is this medium-term thinking that pushes collusion (but not too much of it) into a position of dominance. In the truly long term, nothing is stable because we're all dead anyway.
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by TeMPOraL on Wednesday November 28, 2018 @12:45PM (#18553676)
That's only default for actors that are dumb. Most humans are smart enough to take advantage of an obviously better strategy that also doesn't really require coordination.
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by antisthenes on Wednesday November 28, 2018 @12:48PM (#18553713)
Right, but even that should be called implicit collusion.
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by clairity on Wednesday November 28, 2018 @12:54PM (#18553791)
technically yes, that is the default strategy in perfectly competitive markets, but collusion happens because it maximizes profit for both companies despite it being anti-capitalist.

for plausible deniability, the two companies typically don't directly talk to each other, but a lot of signalling happens via public statements and marketing channels to indicate a desire not to compete (as a simplistic example: raising prices when the competitor lowers theirs).

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by mtgx on Wednesday November 28, 2018 @12:23PM (#18553385)
Can you really say the "market price is X" when there's only been one company making it?

Either way, I think there are some hidden forces here that keep these prices so high. Like if the FDA would open the market to competitors from Europe, or even countries like India, I think that "market price" you say would dramatically lower.

I think the U.S. pharmaceuticals market both lacks competition from generics, as well as has some weird laws like "Medicare can't negotiate prices with pharma companies," which only encourages pharma companies to raise their prices as much as possible.

The law I mention is almost solely responsible for all the "drug X increased price by 5,000%" headlines you've seen lately. Pharma companies have figured out they can shamelessly rob taxpayers and nobody will do a thing about it, as long as they donate to the right politicians (from both parties).

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by refurb on Wednesday November 28, 2018 @12:53PM (#18553779)
"Medicare can't negotiate prices with pharma companies"

That's a common statement, but not really true.

Medicare Part D, which covered prescription drugs, is managed by private insurers who can negotiate for the price of drugs.

In Medicare Part B, which covered physician administered drugs, Medicare pays the average sales price. Which means every time a private insurer gets a lower price, some of that is passed onto Medicare.

So the statement "Medicare can't negotiate drug prices" is technically true, but ignores all the other ways it can get lower drug prices.

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by thaumasiotes on Wednesday November 28, 2018 @12:42PM (#18553639)
Medicare has a different negotiation system built in -- Medicare reimburses a fixed percentage of the minimum amount you charge, to anyone under any circumstances, for the same procedure. This means that doctors who accept Medicare have a price floor set for everyone else by the minimum they need to get from Medicare patients.

(Yes, procedures from doctors aren't the same thing as drugs from manufacturers.)

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by niftich on Wednesday November 28, 2018 @12:57PM (#18553821)
It's worth noting that the Teva device that's the subject of the article is what the FDA considers an 'Authorized Generic'. From the press release [1]:

>"An authorized generic is made under the brand name’s existing new drug application using the same formulation, process and manufacturing facilities that are used by the brand name manufacturer. The labeling or packaging is, however, changed to remove the brand name or other trade dress. In some cases, a company may choose to sell an authorized generic at a lower cost than the brand-name drug product."

While this is different from what common language calls a 'generic drug' [2], in some cases either kind of "generic" could, may, or must be substituted by pharmacists, depending on various circumstances and the particular state's regulatory regime [3].

This interacts with the epinephrine autoinjector market in two ways. First, there is little upside for the manufacturer of the authorized generic to make the list price significantly lower, as the list price is rarely paid by the end-user out of pocket, and frequent mandatory substitution laws cause makers of Authorized Generics to gain marketshare as long as they're slightly cheaper than the brand

Second, Authorized Generics of combination devices are only subsitutable for a corresponding brand, so different devices like Auvi-Q and Adrenaclick are technically a different market entirely: the doctor's prescription will note the exact sort of device. Therefore, while there are other epinephrine autoinjectors, the marketshare among them is decided in doctor's offices and insurance plans, rather than by direct consumer choice through the end-user's own spending.

[1] https://www.fda.gov/newsevents/newsroom/pressannouncements/u... [2] https://www.fda.gov/drugs/developmentapprovalprocess/howdrug... [3] (2008) (for illustration only) https://www.uspharmacist.com/article/generic-substitution-la...

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by paulie_a on Wednesday November 28, 2018 @02:28PM (#18554787)
You can tell your doctor to prescribe a cheaper alternative. If the doctor has no reason to not do so, time to get a new doctor.
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by makomk on Wednesday November 28, 2018 @03:17PM (#18555223)
The Authorized Generic is a different product that's in direct competition with the Teva device, as I understand it.
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by aaavl2821 on Wednesday November 28, 2018 @12:45PM (#18553679)
Typically each new entrant prices lower than the previous entrant to gain market share. The PBMs and retailers already buy the Mylan authorized generic, which is the same product and same price as the Teva product. So they have ability to tell Teva that they need to drop the price or they wont work w them. This is a typical dynamic in newly generic pharma markets
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by cgag on Wednesday November 28, 2018 @12:24PM (#18553401)
Why would I buy a knockoff for the same price?
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by exabrial on Wednesday November 28, 2018 @12:34PM (#18553535)
I previously worked for a prescription claim processor and can answer this.

The unique thing about the Drug market is there are no knockoffs. A "Brand Name" drug in the USA has the _exact_ same active ingredients (and sometimes inactive, take inhalers) as the Generic. Even more hilariously, most drug companies will create a "generic" version of their drug as well as a "branded" because they can sell the same exact thing at a higher price point.

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by jonlucc on Wednesday November 28, 2018 @01:04PM (#18553910)
And yet my mother is 100% convinced that the generic of a drug gives her chronic headaches while the "brand name" version doesn't.

If I'm not mistaken, the formulation could be wildly different as long as they match kinetics, yield, and safety profiles set by the FDA, and an individual may have some issue with one formulation over another.

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by exabrial on Wednesday November 28, 2018 @03:41PM (#18555451)
The FDA certifies the entire formulation, which includes everything from the binding/filler chemicals, anti-caking agents, the pill coatings, and even the ink used to mark the pill (which is why imprinting is very popular).

What you're referring to is the ability of a pharmacist to substitute one drug for another, if for instance it wasn't on your insurance's formulary (list of drugs they'll pay for). Drug A may be slightly different than Drug B, but the Drug B your insurance will pay for. Drug B might also _just happen to be_ a generic (because the pharmacist is trying to get your the best deal for your money). There's guidelines from the FDA, DEA, the state insurance commissioner, and state laws the pharmacists must be aware of so it varies greatly between states on what they're allowed to do. Made for a fun rules engine to implement in software.

Doctors can mark a prescription as DAW (Dispense As Written) which then the pharmacist can make 0 substitutions. Insurance companies aren't usually a fan of said doctors.

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by perl4ever on Wednesday November 28, 2018 @05:02PM (#18556101)
"The FDA certifies the entire formulation, which includes everything from the binding/filler chemicals, anti-caking agents, the pill coatings, and even the ink used to mark the pill (which is why imprinting is very popular)."

Sometimes the FDA certifies a dosage of a generic based on a different dosage. This caused a problem not long ago when the dosage they assumed was fine didn't dissolve right, hence the absorbed dosage varied and was sometimes way too low. To add insult to injury, it was a psychotropic drug, so everyone assumed patients complaining were "just imagining things" for a long time.

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by cbanek on Wednesday November 28, 2018 @03:36PM (#18555394)
Parent comment states active ingredients are the same, but the "non-active" ingredients can be different. So there is the possibility that something is different in the generic that could cause a reaction.

I've had to use transdermal medication (patches) before, and one of the inactive ingredients that changes is the adhesive, I've noticed that the "brand name" version didn't cause skin breakouts, and the generic did.

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by perl4ever on Wednesday November 28, 2018 @05:02PM (#18556107)
You could also have differences in the manufacturing conditions, quality control, and such.
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by cbanek on Wednesday November 28, 2018 @05:04PM (#18556116)
Very true, same manufacturer could also have a bad batch for these reasons even.
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by antiterra on Wednesday November 28, 2018 @12:44PM (#18553671)
That’s not entirely true when talking about auto-injectors that may or may not have needle hiding mechanisms, convenient form-factor, simple or well-known operation, or voice narration (auvi-q).

I am a parent of two young children with tree nut allergies, and I strongly prefer the Auvi-Q despite them gouging my insurer/employer. I use the generic epi-pen for school and child care since that’s what teachers are familiar with.

List price for Auvi-Q is around $5000 an injector. I carry _four_ of them everywhere I go. It’s utterly ridiculous for a dose of medicine worth less than $2, but when I need to use one I’m glad I’m not using a syringe or more complicated off-brand.

Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by exabrial on Wednesday November 28, 2018 @03:33PM (#18555371)
I was specifically referring to drugs, medical devices are a completely different animal.
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by antiterra on Thursday November 29, 2018 @01:14AM (#18558451)
Are you misunderstanding that the ‘medical devices’ I was referring to are just like the Epi-Pen, and pre-filled with epinephrine for one-time use? I assume your reference to inhalers was to drugs similar to albuterol that include aerosol delivery ‘devices.’
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by russdill on Wednesday November 28, 2018 @03:27PM (#18555319)
The "easy" way to fix this is to take the market out of the equation.
Re:FDA promised a ‘lower-cost option’ to EpiPen, but the pri... by jimmy1 on Wednesday November 28, 2018 @12:20PM (#18553363)
/r/LateStageCapitalism/

But if you are being serious...

Because $300 dollars for a drug that people rely on to live is too high, and it makes more economical sense to continue to sell alive people a drug at a price they can afford for longer, than keep selling it at $300 for a short time, until they go bankrupt and die.