A recent example of the FDA stepping in to help alleviate a drug shortage involves high-flying Spectrum Pharmaceuticals and its anticancer drug, Fusilev (levoleucovorin, in 50-mg single-use vials). Given the ongoing shortage of both levoleucovorin and its cousin leucovorin, the agency has given the drugmaker a temporary OK to import levoleucovorin 100-mg powder for injection for U.S. distribution.
In addition to Spectrum, Teva Pharmaceuticals, Bedford Labs and APP currently appear in the short supply notification referencing leucovorin. Its shortage traces back to at least 2008. Explanations have been sketchy and currently include the oft-cited "manufacturing delays." Bedford Labs in 2009 said a facility expansion interrupted supply. Reuters says contamination problems affected the suppliers, and Teva had to close one of its plants last April.
Despite the number of suppliers, Spectrum stands alone in implementing the import fix. "There have not been any other firms so far willing and able to import," says FDA spokesperson Shelly Burgess in an email. "However[,] FDA continues to explore additional supplies to help with the shortage."
Spectrum may have a greater interest than its competitors in the levoleucovorin supply. Reuters notes that Fusilev contributes the majority of the drugmaker's revenue. And the news outlet cites an industry analyst who says that if the manufacturing issues for other suppliers continue, Fusilev is likely to continue helping Spectrum prosper. Furthering its dependence on the drug, Spectrum says it anticipates an FDA decision next month on an application for supplemental use.
Another example of an FDA effort to alleviate a drug supply shortage involves Foradil Aerolizer, Burgess says. Novartis continues to release the asthma treatment with an outdated MedGuide--with the FDA's approval. The guide references aluminum pouch packaging that is no longer in use. Novartis sent a Dear Pharmacist letter to explain the outdated reference in the guide and to say an update is in the works.
- here's the levoleucovorin/leucovorin short supply listing
- here's the Reuters report
- see the Dear Pharmacist letter