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EpiPen Price Rise Sparks Concern for Allergy Sufferers

well.blogs.nytimes.com

291–300 of 367 posts

Re: EpiPen Price Rise Sparks Concern for Allergy Sufferers

#291

Someone might reasonably wonder why a federal task force is required to investigate "price gouging" for an item that contains under $10 of materials and is not mechanically complex. Why wouldn't an entrepreneur simply introduce a competing epi-pen design and bring it to market for $300 (for example) and undercut the price being charged by Mylan? We're told to hate the Martin Shkrelis of the world, and to resend the M…

First: I don't disagree with you about price gouging and the need for a solution. i spend time awake at night thinking about it.

Considering COGS in Biologics drugs pricing is a logical fallacy. The $10 is irrelevant. You have to amortize in all the time, and expenses required to establish a sterile fill and finish facility, or the required capacity of a new product in an existing facility. A reasonable accountant would also probably throw in some of expense for the patent lawyers generic firms have in legion, or R&D pharma has. Maintain a large amount of sterile injectable manufacturing capacity at "drop-of-the-hat" availability to absorb/profit from such market fluctions at low pricing? Not a business model anybody would fund, or would keep someone employed in pharma. Does that justify the new price, probably not. Does it make a $300 pen a great business plan? Probably not. Hopefully that changes as the parasitic business models of the Valeants and Skrelli's of the world are receive due scrutiny.

Re: EpiPen Price Rise Sparks Concern for Allergy Sufferers

#292

Someone might reasonably wonder why a federal task force is required to investigate "price gouging" for an item that contains under $10 of materials and is not mechanically complex. Why wouldn't an entrepreneur simply introduce a competing epi-pen design and bring it to market for $300 (for example) and undercut the price being charged by Mylan? We're told to hate the Martin Shkrelis of the world, and to resend the M…

The government has created a moat for the current pen through regulation, particularly the extensive testing needed to bring it to market as a medical device whom people's lives depend on it delivering the right dosage with a low failure rate. This creates something of a small granted monopoly. It makes sense for the government to step in when something goes wrong. There are lots of theoretical arguments for a freer…

> a market trial and error approach seems a little barbaric.

The average American earns less in a week than the cost of one epi pen. No, "nonfarm" statistics don't apply since people who work on farms still need epi pens.

> It makes sense for the government to step in when something goes wrong.

What has gone wrong in this case? The protected cronies of regulators are making a tidy profit after spending years cozying up, making political donations, and building a revolving door between industry and government.

In actuality, in this case everything has gone abundantly right for regulators and firms. The task force will likely warn them that they should have just been satisfied with $350 per pen to avoid the bad press.

Re: EpiPen Price Rise Sparks Concern for Allergy Sufferers

#293

Earlier quoted context omitted.

In both situations, the government sets a minimum permissible safety standard to sell the product. Medications and medical devices are allowed to kill/injure, but only to a point. Same with cars.

The Government doesn't forbid you, the consumer, from buying questionable cars. It's the manufacturer who is restricted by Government regarding what cars they can sell.

> The Government doesn't forbid you, the consumer, from buying questionable cars.

Yes, they do. There are special regulations around salvage vehicles. Most (all?) states require cars to pass inspection to be on the road. The FTC requires certain disclosures on used cars. WA won't let you sell a post-1964 car - even in a private sale - without seatbelts (http://apps.leg.wa.gov/rcw/default.aspx?cite=46.37.510). etc. etc. etc.

Re: EpiPen Price Rise Sparks Concern for Allergy Sufferers

#294
post #36

Earlier quoted context omitted.

so how is this insurance company getting away with what they're doing? you'd think someone else would produce it, sell it for <$100, and people would just buy them out of pocket. what stops that?

> so how is this insurance company getting away with what they're doing? It's not the insurance company, it's the drug company. The insurance companies are probably livid about the extra costs they're having to cover. The answer to "how" is a variety of different techniques, including changing the formulation slightly ( http://www.nytimes.com/2014/09/16/business/new-york-files-an... ) and outright bribery of competit…

yup, and in this case and many others, it is only the insurance companies that will save the populous at large. Only they have the negotiating power to encourage competition and affect the laws regarding these devices

Re: EpiPen Price Rise Sparks Concern for Allergy Sufferers

#295

Someone might reasonably wonder why a federal task force is required to investigate "price gouging" for an item that contains under $10 of materials and is not mechanically complex. Why wouldn't an entrepreneur simply introduce a competing epi-pen design and bring it to market for $300 (for example) and undercut the price being charged by Mylan? We're told to hate the Martin Shkrelis of the world, and to resend the M…

There's a $150 alternative available. http://www.goodrx.com/adrenaclick

But they don't offer it in a dosage appropriate for young kids (0.15mg) like Epipen Jr.

Re: EpiPen Price Rise Sparks Concern for Allergy Sufferers

#296
post #287

Earlier quoted context omitted.

For anyone as confused as I was, I'm presuming that, Michael Skakels=Martin Shkreli?

My understanding as well, though it took a moment.

Oops, that is among the more amusing typos I've committed :)

Re: EpiPen Price Rise Sparks Concern for Allergy Sufferers

#297
post #291

Someone might reasonably wonder why a federal task force is required to investigate "price gouging" for an item that contains under $10 of materials and is not mechanically complex. Why wouldn't an entrepreneur simply introduce a competing epi-pen design and bring it to market for $300 (for example) and undercut the price being charged by Mylan? We're told to hate the Martin Shkrelis of the world, and to resend the M…

First: I don't disagree with you about price gouging and the need for a solution. i spend time awake at night thinking about it. Considering COGS in Biologics drugs pricing is a logical fallacy. The $10 is irrelevant. You have to amortize in all the time, and expenses required to establish a sterile fill and finish facility, or the required capacity of a new product in an existing facility. A reasonable accountant wo…

Your point about R&D is valid, but in this case epi was first synthesized in 1895 and the R&D cost has long since been amortized and the IP is in the public domain.

http://www.patent-invent.com/adrenaline_patent.html

This article suggests that it was in fact a very shrewd business plan:

http://www.bloomberg.com/news/articles/2015-09-23/how-market...

Re: EpiPen Price Rise Sparks Concern for Allergy Sufferers

#298
post #295

Earlier quoted context omitted.

There's a $150 alternative available. http://www.goodrx.com/adrenaclick

But they don't offer it in a dosage appropriate for young kids (0.15mg) like Epipen Jr.

On the page I link, I'm able to click the dropdown menu by the dosage and select 0.15 mg.

Re: EpiPen Price Rise Sparks Concern for Allergy Sufferers

#299

Earlier quoted context omitted.

Seems to me that less testing is necessary for an established product. Are there patents involved?

Sure, any company wishing to enter the market can use the expired patent as a reference.

It looks like there's a minefield of patents granted post-1995[0]; and so which enjoy a 20-year term of protection.

I can't see why any protection is necessary.

0: https://news.ycombinator.com/item?id=12344059

Re: EpiPen Price Rise Sparks Concern for Allergy Sufferers

#300

Earlier quoted context omitted.

Thanks for this summary comment. This is backed in the literature by people who are systems / usability engineers: tldr: Reliable design is HUGELY important. You can't just put these things together haphazardly. "The fact that less than 50% of participants across all devices could follow the labeled instructions without committing a single error provides confirmation that the need for training on the use of epinephri…

In the study below, moms of kids with severe allergies were trained to use the EpiPen. Six weeks later in a simulated test, only about two out of five were able to successfully deliver a lifesaving dose of adrenaline. Shouldn't the FDA require that manufacturers provide evidence that consumer medical devices can be used reliably for their intended purpose? https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4654245/ Patient…

They should allow reasonably safe products that are among the best available options.

So if people can use an Epipen more reliably than they can prepare an injection, allow it to be marketed. If someone with a history of anaphylaxis is better off with an Epipen than they are with no treatment at all, allow it to be marketed.

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