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You're mixing up your concepts here: orphaned drugs are those that would not be profitable to produce without a subsidy. The drugs Shkreli acquired were profit
by howlgarnish 6y ago
You're mixing up your concepts here: orphaned drugs are those that would not be profitable to produce without a subsidy. The drugs Shkreli acquired were profitable and still produced, but out of patent (so they were cheap) and without an approved generic version (so there was no existing competition).
Legally, it was above board, and financially, it was sensible regulatory arbitrage. Morally, though, it was reprehensible.
- deleted 6y ago[deleted]
- dnautics 6y agoSorry you're right, I had the terminology wrong. It's abandoned, not orphaned, and the specific program is FDA NCIE. IIRC this program grants advertising exclusivity (weaker than patent exclusivity) as a carrot to give companies "IP protection-lite" in exchange for re-testing old drugs under the FDA phase flow.