In an unusual move, the Food and Drug Administration has acknowledged a mistake and revoked orphan drug status for an opioid addiction treatment that was approved two years ago, clearing the way for another injection of buprenorphine to possibly reach the market.
Specifically, the agency withdrew orphan designation and exclusivity for Sublocade, which was approved nearly two years and hailed as a potential game changer for combating the opioid crisis. But the move generated controversy because of a quirk in the law that critics complained should not have allowed the manufacturer, Indivior, to win orphan status and crowd out competitors.
How so? The back story is complicated, but here goes.
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