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posted by cmn32480 on Wednesday April 26 2017, @04:44PM   Printer-friendly
from the all-about-the-Benjamins dept.

Dr. Lowe, from In the Pipeline, writes an update on a story we covered earlier this year:

You may recall Marathon Pharmaceuticals, the small company that announced plans to sell a long-used steroid treatment (Emflaza, deflazacort) in the US to Duchenne muscular dystrophy patients. The price was set to go up steeply, since the company was awarded years of market exclusivity by the FDA (under their program to reward orphan-drug indications like this one).

This business model is the same one followed by a number of other small outfits (see that link above for more), and it's infuriating. Generic drugs are off patent, by definition, and they're supposed to be cheap. Taking advantage of regulatory loopholes and perverse incentives to jack their prices up is shameful, unproductive, and expensive.

[...] Marathon itself appears to be about to disappear. And why not? They've turned a quick buck. Endpts, who have been doing a great job on this story, couldn't find anyone who thought that the company had spent more than $70 million on the drug's approval, and it was probably a lot less. So $140 million, plus milestones and royalties, is a nice return. But there's more money coming than just that – the company got a priority review voucher from the FDA for bringing a rare pediatric disease drug to the market, and they can sell that on the open market. I'd guess that it could bring in another $100 million or so

http://blogs.sciencemag.org/pipeline/archives/2017/04/25/marathon-pharmaceuticals-cashes-out

https://en.wikipedia.org/wiki/Deflazacort

The priority review voucher is an incentive program that provides companies, that get a drug approval for a neglected or rare disease, a voucher that entitles them to a more speedy review (under six months instead of ~10 months) for a future drug. This is a great program; however, Marathon Pharmaceuticals deliberately exploited this program by conducting a very small trial using a generic drug (another loophole).

Previous Story: https://soylentnews.org/article.pl?sid=17/02/11/2116252


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  • (Score: 2, Disagree) by bradley13 on Wednesday April 26 2017, @05:08PM (6 children)

    by bradley13 (3053) on Wednesday April 26 2017, @05:08PM (#500163) Homepage Journal

    This is a poster-child example for crony capitalism, i.e., undeserved profits made possible through bought-and-paid-for government regulation.

    Less government would be more.

    --
    Everyone is somebody else's weirdo.
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  • (Score: 2) by Grishnakh on Wednesday April 26 2017, @05:55PM (1 child)

    by Grishnakh (2831) on Wednesday April 26 2017, @05:55PM (#500217)

    Government regulation seems to work pretty well overall in western Europe; we never see stories like this over there, and drug prices are really cheap both there and in neighboring Canada.

    So why is it the government regulation in the US usually results in crap like this?

    • (Score: 2) by kaszz on Wednesday April 26 2017, @05:57PM

      by kaszz (4211) on Wednesday April 26 2017, @05:57PM (#500221) Journal

      So why is it the government regulation in the US usually results in crap like this?

      Answer: Who pays for politicians? :-)

  • (Score: 3, Insightful) by DannyB on Wednesday April 26 2017, @05:56PM

    by DannyB (5839) Subscriber Badge on Wednesday April 26 2017, @05:56PM (#500220) Journal

    How about: Less government CORRUPTION. Government exists to regulate. The problem isn't the regulation so much as the corruption, the crony capitalism that you point out. I'm for less government, as long as it can regulate abusive behavior.

    --
    People today are educated enough to repeat what they are taught but not to question what they are taught.
  • (Score: 3, Informative) by Joe on Wednesday April 26 2017, @06:08PM

    by Joe (2583) on Wednesday April 26 2017, @06:08PM (#500234)

    The program was developed to address a very real problem with market-based solutions for drug development. The problem is obvious: the market will only drive development of profitable drugs and will neglect diseases that are either rare (e.g. muscular dystrophy, ALS, Huntington's) or only prevalent in populations that are poor (e.g. dengue, Chagas, zika, chikungunya).

    To help address this problem, some professors (from the economics and business departments of Duke University) proposed the priority review system as a subtle way to make developing orphan drugs more profitable to the market by (in a way) coupling their success with that of blockbuster drugs. This program uses the market to set the price of priority review vouchers and it does not increase regulations or review time for any other drugs.

    TL/DR: Unprofitable diseases become more profitable (better for neglected patients), blockbuster drugs get to market earlier (better for patients), and no increased regulatory burden.

    The loophole, which needs to be fixed, that was exploited in this case was that generic drugs from other countries can qualify if they can be applied to new indications in the US (after acquiring FDA approval). What Marathon Pharmaceuticals did (run a clinical trial and get FDA approval for the drug) is worth something, but it really shouldn't have qualified for the program.

    http://content.healthaffairs.org/content/25/2/313.abstract [healthaffairs.org]
    https://en.wikipedia.org/wiki/Food_and_Drug_Administration_Amendments_Act_of_2007#Title_XI:_Other_Provisions [wikipedia.org]
    https://en.wikipedia.org/wiki/Orphan_Drug_Act_of_1983 [wikipedia.org]
    https://en.wikipedia.org/wiki/Neglected_tropical_diseases [wikipedia.org]

    - Joe

  • (Score: 3, Insightful) by Azuma Hazuki on Wednesday April 26 2017, @07:59PM

    by Azuma Hazuki (5086) on Wednesday April 26 2017, @07:59PM (#500314) Journal

    Oh sure, and by that metric, because some people use guns to commit murders, the solution is less guns, riiiiiiiiiight? :D

    THINK before you say something like that. Regulations don't kill people, regulatory capture does.

    --
    I am "that girl" your mother warned you about...
  • (Score: 1) by DannyB on Wednesday April 26 2017, @08:15PM

    by DannyB (5839) Subscriber Badge on Wednesday April 26 2017, @08:15PM (#500323) Journal

    It is not 'govmint'. It's 'gubmit'. A noun. Here is an example of the proper use of the word in a sentence:

    Dem gubmit foaks shore is ignert.

    --
    People today are educated enough to repeat what they are taught but not to question what they are taught.