The FDA was able to prevent 38 "close calls" from turning into drug shortages last year by speeding approval of manufacturing changes or forewarning drugmakers. It's also facilitated the import of drugs not approved for use in the U.S. to maintain supplies of medically necessary treatments.
FDA spokeswoman Shelly Burgess says in an email that the agency can't name the companies involved in the incidents. But it helped them address quality and manufacturing issues so that "supplies could continue to be available while ensuring no risk for U.S. patients."
In addition, the agency approved new manufacturing sites, as well as raw material and component suppliers in time to avoid a shortage, thanks to early notification from drugmakers. And when notified in advance by drugmakers that intended to discontinue multi-sourced drugs, regulators informed the other suppliers so they could be ready to meet the shortfall.
In April, the FDA worked with cytarabine-producers Hospira, APP Pharmaceuticals and Bedford Labs during an API shortage. It located an overseas maker of the leukemia drug willing to temporarily import the injections for U.S. use, even though the import is technically unapproved by the regulator.
Another case involves the anticancer drug, Fusilev (levoleucovorin, in 50-mg single-use vials) from Spectrum. In this case, the regulator gave the drugmaker a temporary OK to import levoleucovorin 100-mg powder for injection for U.S. distribution.
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