Opinion: Orphan Drug Act’s ‘nonprofitability’ loophole needs to be closed
Last month, the Food and Drug Administration took the unusual step of admitting it had made a mistake 25 years ago when it granted orphan drug status to an opioid addiction treatment called buprenorphine (Subutex).
The original orphan drug application was based on the claim by Indivior, the maker of Subutex, that the company was not likely to make a profit from marketing the drug. At the time, opioid addiction was not the widespread scourge it is today.
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