Under current law, companies that are the sole manufacturer of certain drug products must notify the FDA at least six months before discontinuing the manufacturing of a product. These include FDA-approved products that are life supporting, life sustaining or used to prevent debilitating diseases or conditions, and are not originally derived from human issue and replaced by a recombinant product.
Now, FDA is defining "discontinuance" to include both permanent and temporary interruptions in manufacturing, if the interruption can lead to a shortage. The agency also is clarifying what it considers to be a "sole manufacturer" of a product.
"Recent experience with drug shortages in the United States has shown the serious and immediate impacts they can have on patients and health care providers, particularly those shortages involving drugs that are manufactured by a small number of firms and for which there are no good therapeutic substitutes available," the interim final rule states. "The number of drug shortages annually has tripled from 61 in 2005 to 178 in 2010."
The rule is available here and will be published in the Federal Register on Dec. 19.
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