This article gives an average fee of $1M and wait time of 40 months for a manufacturer to be approved to sell a generic drug. And that's just the fee to the FDA -- it doesn't include the cost of running human studies (which can cost tens of millions) or other compliance costs.https://twitter.com/aclough/status/1184486748321189888 …
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The fees, study costs, and fixed costs of compliance (having lawyers and compliance experts on staff, extra documentation, etc) don't scale with the size of the business; a small factory has to pay as much as a large one. So incumbents are favored.
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But the biggest incumbents are pharma companies, which make most of their money on patented blockbuster drugs, and are prone to discontinue production of generics, as Teva just did for vincristine. Without new generics companies to pick up the slack, patients are screwed.
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Honestly, this is an opportunity for some company to pull an Uber and just flagrantly violate the law while rapidly becoming so popular with consumers that the FDA can't afford the public outcry of shutting you down.
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Replying to @s_r_constantin
highly doubt people are gonna be willing to buy non-FDA approved generic drugs direct from a supplier en masse; certainly not prescription drugs which are presumably the main issue and pharmacies won't touch that with a 100 foot pole
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Replying to @halvorz
No, I was thinking something like PillPack (or maybe literally PillPack, I dunno!)
@The_Lagrangian can neither confirm nor deny, I'm sure.1 reply 0 retweets 2 likes -
Replying to @s_r_constantin @The_Lagrangian
but PillPack doesn't make drugs? maybe I'm misreading your proposal
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Replying to @halvorz @The_Lagrangian
No, PillPack is the pharmacy that sells the drugs. There are plenty of cheap generic drug manufacturers in China and India; the reason people don't all use them is a.) low trust (they might sell you adulterated drugs), and b.) poor distribution channels
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(Grandma's not on the Dark Web, she doesn't know how to get shady off-brand meds.) An online pharmacy that invests heavily enough in customer acquisition that health plans have it as a default, can do both the quality control and distribution. And improve customer experience!
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https://www.cnbc.com/2019/05/10/why-amazon-bought-pillpack-for-753-million-and-what-happens-next.html … PillPack sounds like it might be in a position to replace pharmacy benefit managers -- the handful of middlemen between the pharmacies & insurers -- by building its own billing software. Not sure how this plays in but it could be helpful.
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Replying to @s_r_constantin @halvorz
the hilarious thing about PBMs was that they were originally introduced as a price control measure, and immediately became a purely evil bureaucratic layer
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