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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Imagine a national pharmacy chain -- make it a delivery service, why not -- that sources its generic drugs internationally, using only purity testing to confirm they're the real thing, not the more elaborate FDA test.
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The pharmacy gets reimbursed by insurers and pockets the profit from getting cheaper drugs. You might even get health plans to love it, because without long pharmacy waits, compliance goes up, and with generic-only pricing, reimbursement costs go down.
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