3/6/2017 Why Did That Drug Price Increase 6,000%? It’s The Law
https://www.forbes.com/sites/matthewherper/2017/02/10/aÂ6000ÂpriceÂhikeÂshouldÂgiveÂdrugÂcompaniesÂaÂdisgustingÂsenseÂofÂdejaÂvu/print/ 1/5
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PHARMA & HEALTHCARE 2/10/2017 @ 1:52PM 24,770 views Why Did That Drug Price Increase
6,000%? It’s The Law
Groundhog Day, anyone? (Photo by Andrew Burton/Getty Images)
It’s happened again. Of course it has happened
again. A drug company has brought a drug that
has been available as a generic elsewhere in the
world for decades at a shockingly inflated price.
The drug, in this case, is a steroid called
deflazacort, has been approved for treating kids
with Duchenne muscular dystrophy. It has fewer
side effects than existing steroids, and many
patients have been getting it from Europe or
Canada at a price between $1,000 or $2,000 a
year.
Yet a pharmaceutical company in Deerfield, Ill.,
has gotten approval from the U.S. Food and Drug
Administration to sell deflazacort (snazzy brand
name: Emflaza). The company, Marathon
Pharmaceuticals, is charging a list price of
$89,000 – a 6,000% price increase.
Savemoney today…
Matthew Herper Forbes Staff
I cover science and medicine, and believe this is biology’s century.
3/6/2017 Why Did That Drug Price Increase 6,000%? It’s The Law
https://www.forbes.com/sites/matthewherper/2017/02/10/aÂ6000ÂpriceÂhikeÂshouldÂgiveÂdrugÂcompaniesÂaÂdisgustingÂsenseÂofÂdejaÂvu/print/ 2/5
If this doesn’t feel like déjà vu all over again, you
haven’t been paying attention. Yes, it was a
5,000% price increase on a drug for a rare
infection that made Martin Shkreli, then chief
executive of Turing Pharmaceuticals, “the most
hated man on the Internet.†But Shkreli’s was an
incremental innovation in price gouging. Before
that, we had the case of Makena, used to prevent
preÂterm birth. It was launched in 2011 at a price
of $1,500 when a similar drug was previously
available, from compounding pharmacies, for
$20. The strategy basically worked: AMAG
Pharmaceuticals, which now owns Makena,
booked sales of $93 million in the third quarter
of last year.
Why does this keep happening? Well, with the
exception of Shkreli, enabled by a thicket of
market inefficiencies, because it’s the law. And
that’s very much the case for Marathon and
Emflaza.
Because this steroid has never been approved in
the United States, the Food and Drug
Administration considers it a new drug. That
means that not only did Marathon have to go
through the process of getting it approved as a
new drug, but that it gets the benefit of laws
Congress has passed to encourage drug
companies to develop new medicines for rare
diseases.
Those legal benefits include a 7Âyear monopoly
under the Orphan Drug Act, and a rare disease
priority review voucher that allows a company to
get a spedÂup FDA review for another drug. Such
vouchers can be sold for large sums.
The idea behind those benefits is that society
needs to pay in order for drugs for rare diseases
to be developed. It seems obvious that getting a
generic steroid that is approved in the rest of the
world through the FDA should not have the same
benefits to a company as inventing a new
medicine. Yet, under the law, it does.
This isn’t ShkreliÂlevel malfeasance. Mitigating
factors: Marathon says that only 7% to 9% of the
patients who could benefit from Emflaza were
able get access to it by importing the drug from
other countries. In order to get the FDA
approval, Marathon conducted 17 clinical and
preÂclinical trials, and had to go back and find
the data from studies conducted by the drug’s
3/6/2017 Why Did That Drug Price Increase 6,000%? It’s The Law
https://www.forbes.com/sites/matthewherper/2017/02/10/aÂ6000ÂpriceÂhikeÂshouldÂgiveÂdrugÂcompaniesÂaÂdisgustingÂsenseÂofÂdejaÂvu/print/ 3/5
original manufacturer. The FDA is making
Marathon conduct postÂapproval studies,
including one in children younger than five.
Does this justify a 6,000% price increase?
Marathon says it actually expects to net “onlyâ€
$54,000 a year from insurers. The company has
also said its business will not be profitable for
several years. It expects patients with insurance
to get access to the drug for a coÂpayment, and
will give it away to others for free. In other
words, the high cost of this medicine is not
intended to gouge patients, but to get us all to
pay not only for the cost of getting the drug
through FDA, but also to provide a big profit that
will incentivize drug makers to bring more drugs
to the United States.
This lays bare one of the absurdities of the FDA
process: for a drug to be approved, a company
must do the work of bringing it to market. For
new medicines, developed at high cost by
pharmaceutical companies, this is the right
approach. But for medicines that have been in
clinical use for decades it may not be. Imagine
how much money we would all save if we paid for
the National Institutes of Health to survey such
drugs, collect realÂworld data on them, and have
the FDA approve them without giving any
company exclusivity? Then generic drug
companies would make the medicines at much
lower cost. Senator Ted Cruz has argued that
drugs approved by European or Canadian
regulators should automatically be approved in
the U.S. That’s not a good idea, because it would
lead to manufacturers of new medicines always
going to whoever set the lowest bar. But for old
medicines a system like that may make sense.
That’s not the system we have. Marathon is
increasing the access of boys with a deadly
disease to a medicine that will help them, and
charging what it thinks is an honest price based
on the regulatory burdens it has. That doesn’t
make the price OK. But it’s how executives can
convince themselves that what they are doing is
OK.
The problem is, it’s not OK. The price is absurd,
and the price increase shortÂcircuits the fairness
circuitry built into the human brain. There’s
some amount that Marathon should charge for
the work it did. But is it $85,000 per patient, or
even $52,000? Probably not. And that priority
3/6/2017 Why Did That Drug Price Increase 6,000%? It’s The Law
https://www.forbes.com/sites/matthewherper/2017/02/10/aÂ6000ÂpriceÂhikeÂshouldÂgiveÂdrugÂcompaniesÂaÂdisgustingÂsenseÂofÂdejaÂvu/print/ 4/5
This article is available online at: 2017 Forbes.com LLCâ„¢ All Rights Reserved
review voucher itself could be worth hundreds of
millions of dollars. Congress is obsessed with
these vouchers. Maybe they’re not the best
solution to problems in the pharma business?
Marathon is a member of the Pharmaceutical
Research and Manufacturers of America
(PhRMA), the drug industry trade group. Drug
companies cannot use their usual argument of
saying this is an “outlier.†This is one of their own
– although Marathon may find itself feeling as if
it is being ostracized from the club. As patent
lawyer Rachel Sachs notes, the big drug giants
need to distance themselves from this move –
and maybe find a way to actually come to the
table on preventing big drug price increases.
Pharmaceutical company executives, here is your
problem: You won’t get credit for the wonderful
innovations your companies produce if your
prices make people feel sick.
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Proceed to order page3/6/2017 Why Did That Drug Price Increase 6,000%? It’s The Law
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PHARMA & HEALTHCARE 2/10/2017 @ 1:52PM 24,770 views Why Did That Drug Price Increase
6,000%? It’s The Law
Groundhog Day, anyone? (Photo by Andrew Burton/Getty Images)
Its happened again. Of course it has happened
again. A drug company has brought a drug that
has been available as a generic elsewhere in the
world for decades at a shockingly inflated price.
The drug, in this case, is a steroid called
deflazacort, has been approved for treating kids
with Duchenne muscular dystrophy. It has fewer
side effects than existing steroids, and many
patients have been getting it from Europe or
Canada at a price between $1,000 or $2,000 a
year.
Yet a pharmaceutical company in Deerfield, Ill.,
has gotten approval from the U.S. Food and Drug
Administration to sell deflazacort (snazzy brand
name: Emflaza). The company, Marathon
Pharmaceuticals, is charging a list price of
$89,000 a 6,000% price increase.
Savemoney today…
Matthew Herper Forbes Staff
I cover science and medicine, and believe this is biology’s century.
3/6/2017 Why Did That Drug Price Increase 6,000%? It’s The Law
https://www.forbes.com/sites/matthewherper/2017/02/10/a6000pricehikeshouldgivedrugcompaniesadisgustingsenseofdejavu/print/ 2/5
If this doesnt feel like dj vu all over again, you
havent been paying attention. Yes, it was a
5,000% price increase on a drug for a rare
infection that made Martin Shkreli, then chief
executive of Turing Pharmaceuticals, the most
hated man on the Internet. But Shkrelis was an
incremental innovation in price gouging. Before
that, we had the case of Makena, used to prevent
preterm birth. It was launched in 2011 at a price
of $1,500 when a similar drug was previously
available, from compounding pharmacies, for
$20. The : AMAG
Pharmaceuticals, which now owns Makena,
booked sales of $93 million in the third quarter
of last year.
Why does this keep happening? Well, with the
exception of Shkreli, enabled by a thicket of
market inefficiencies, because its the law. And
thats very much the case for Marathon and
Emflaza.
Because this steroid has never been approved in
the United States, the Food and Drug
Administration considers it a new drug. That
means that not only did Marathon have to go
through the process of getting it approved as a
new drug, but that it gets the benefit of laws
Congress has passed to encourage drug
companies to develop new medicines for rare
diseases.
Those legal benefits include a 7year monopoly
under the Orphan Drug Act, and a rare disease
priority review voucher that allows a company to
get a spedup FDA review for another drug. Such
vouchers can be sold for large sums.
The idea behind those benefits is that society
needs to pay in order for drugs for rare diseases
to be developed. It seems obvious that getting a
generic steroid that is approved in the rest of the
world through the FDA should not have the same
benefits to a company as inventing a new
medicine. Yet, under the law, it does.
This isnt Shkrelilevel malfeasance. Mitigating
factors: Marathon says that only 7% to 9% of the
patients who could benefit from Emflaza were
able get access to it by importing the drug from
other countries. In order to get the FDA
approval, Marathon conducted 17 clinical and
preclinical trials, and had to go back and find
the data from studies conducted by the drugs
3/6/2017 Why Did That Drug Price Increase 6,000%? It’s The Law
https://www.forbes.com/sites/matthewherper/2017/02/10/a6000pricehikeshouldgivedrugcompaniesadisgustingsenseofdejavu/print/ 3/5
original manufacturer. The FDA is making
Marathon conduct postapproval studies,
including one in children younger than five.
Does this justify a 6,000% price increase?
Marathon says it actually expects to net only
$54,000 a year from insurers. The company has
also said its business will not be profitable for
several years. It expects patients with insurance
to get access to the drug for a copayment, and
will give it away to others for free. In other
words, the high cost of this medicine is not
intended to gouge patients, but to get us all to
pay not only for the cost of getting the drug
through FDA, but also to provide a big profit that
will incentivize drug makers to bring more drugs
to the United States.
This lays bare one of the absurdities of the FDA
process: for a drug to be approved, a company
must do the work of bringing it to market. For
new medicines, developed at high cost by
pharmaceutical companies, this is the right
approach. But for medicines that have been in
clinical use for decades it may not be. Imagine
how much money we would all save if we paid for
the National Institutes of Health to survey such
drugs, collect realworld data on them, and have
the FDA approve them without giving any
company exclusivity? Then generic drug
companies would make the medicines at much
lower cost. has argued that
drugs approved by European or Canadian
regulators should automatically be approved in
the U.S. Thats not a good idea, because it would
lead to manufacturers of new medicines always
going to whoever set the lowest bar. But for old
medicines a system like that may make sense.
Thats not the system we have. Marathon is
increasing the access of boys with a deadly
disease to a medicine that will help them, and
charging what it thinks is an honest price based
on the regulatory burdens it has. That doesnt
make the price OK. But its how executives can
convince themselves that what they are doing is
OK.
The problem is, its not OK. The price is absurd,
and the price increase shortcircuits the fairness
circuitry built into the human brain. Theres
some amount that Marathon should charge for
the work it did. But is it $85,000 per patient, or
even $52,000? Probably not. And that priority
3/6/2017 Why Did That Drug Price Increase 6,000%? It’s The Law
https://www.forbes.com/sites/matthewherper/2017/02/10/a6000pricehikeshouldgivedrugcompaniesadisgustingsenseofdejavu/print/ 4/5
This article is available online at: 2017 Forbes.com LLC All Rights Reserved
review voucher itself could be worth hundreds of
millions of dollars. Congress is obsessed with
these vouchers. Maybe theyre not the best
solution to problems in the pharma business?
Marathon is a member of the Pharmaceutical
Research and Manufacturers of America
(PhRMA), the drug industry trade group. Drug
companies cannot use their usual argument of
saying this is an outlier. This is one of their own
although Marathon may find itself feeling as if
it is being ostracized from the club. As patent
lawyer Rachel Sachs notes, the big drug giants
need to distance themselves from this move
and maybe find a way to actually come to the
table on preventing big drug price increases.
Pharmaceutical company executives, here is your
problem: You wont get credit for the wonderful
innovations your companies produce if your
prices make people feel sick.
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Any academic writer who wishes to join our team of professional writers must possess all the following qualities:
To write an exemplary academic paper, you must have good critical thinking skills, possess the proper knowledge of the discipline, and be knowledgeable about applying an academic writing style.
As such we have a rigorous recruitment process. We only collaborate with professional academic writers. We believe in offering the highest quality academic writing services. Our writers pass various grammar and academic writing tests. They have to provide documents about their personal information and credentials to prove their level of expertise.
As a result, our clients receive papers that are thoroughly-researched, properly cited, and written within academic standards. We are proud that any academic writer from our writer's team can complete the paper at a high standard.
We work with the student’s budget because we know that students are usually on a budget majority of the time. We do not compromise on quality because of low prices. On the contrary, we love to foster a good relationship with our clients. That is why we charge our clients reasonable prices, and we are willing to negotiate and work with their budget.
It may be quite disturbing to decide whether to hire an academic writing company. We care about our client’s privacy and confidentiality. We never disclose your information to third parties. We never publish your paper online. You can use our academic writing service without any fear or anxiety.
Many students struggle with writing academic papers. Some barely have time to do their assignments because of their job and family responsibilities. Others have difficulty applying critical thinking skills or meeting time or assignment requirements. Whatever the reason is, you can always have time to do the things you love and other important things. All you need is a reliable and quality academic writing service. Unfortunately, even if you strongly desire to write the paper yourself, you sometimes face unexpected challenges. As we all know, life is unpredictable! Your teacher may be unconcerned about helping students and may not answer your questions. The good news is that there is a way out! You can hire an online academic writer to help you with your assignments. All you need to do is stipulate your paper requirements in the order form, and you can spend your time as you like.
Our company commits towards delivering high-quality custom papers to our clients. We seek to offer reliable essay writing services to our customers in various subject areas. Our customers are very valuable to us. As such, we commit to ensuring that they derive the utmost satisfaction from the essays we deliver. We have a mission to promote our clients' educational and professional lives by providing high-quality essays for their use. We also have a mission to offer a convenient essay writing system where our customers can easily order and pay for the services. We value quality and professionalism in our company.
We write papers on any subject area, and we also write various types of papers for various purposes. We have a team of able writers who are eager to help our customers with writing services of exceptional quality. We offer custom writing services for customers across the globe and charge affordable prices for our services. We are the best essay writing company offering personalized services to all our customers. We ensure our customers receive maximum satisfaction from the essays we deliver. Our website is the place to be if you are seeking high-quality essays.
By using our academic writing service, we match your paper subject with a writer with a degree in the subject. The writer is able to apply their skills, knowledge, and expertise to the paper. You receive an original, unique, well-research paper, properly cited and formatted. As such, you are assured of a high-quality paper.
Truth be told, writing assignments can be stressful and difficult for any student. There is no shame in getting academic writing help. When you search the term “get academic writing help” there are numerous sites that pop up on the results and our website is among them. So, why is it a great idea to choose us?
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Proceed to order pageDelivering a high-quality product at a reasonable price is not enough anymore.
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You have to be 100% sure of the quality of your product to give a money-back guarantee. This describes us perfectly. Make sure that this guarantee is totally transparent.
Read moreEach paper is composed from scratch, according to your instructions. It is then checked by our plagiarism-detection software. There is no gap where plagiarism could squeeze in.
Read moreThanks to our free revisions, there is no way for you to be unsatisfied. We will work on your paper until you are completely happy with the result.
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