FDA softens tone when addressing unapproved drugs

Like Cody Labs, River's Edge Pharmaceuticals is in hot water for the manufacture and distribution of unapproved drugs. In fact, it's one of several topics covered in Warning Letter 10-ATL-15. However, the careful reader may detect a note of helpfulness when unapproved drugs are concerned.

"FDA understands the need for assistance when securing approval for currently marketed unapproved drugs," the letter says. "As part of our commitment to assist firms through this process, FDA has appointed an unapproved drugs coordinator in the Office of New Drugs, Dr. Sally Loewke, to work with companies trying to bring their products into compliance." The letter advises the company to contact Loewke to start the process.

In Cody's case, much of the warning letter describes enforcement actions the regulator may take, and when. It also includes the ominous statement, "We encourage you to adjust manufacturing to prevent surplus morphine sulfate oral solution that may need to be destroyed. A copy of this letter will be forwarded to DEA." However, the follow-up letter of March 2010, almost a year after the warning letter, reiterates the stern warning but it also adds that "We encourage firms marketing any unapproved drugs to obtain FDA's approval for their products. For assistance please contact the unapproved drugs coordinator in the Office of New Drugs or the Office of Generic Drugs."  

- here's Warning Letter 10-ATL-15

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