Filling The Cupboard: FDA Releases Plan To Fight Drug Shortages

With dozens of drugs still in short supply, the FDA is touting two new steps to mitigate the problem. One is a strategic plan designed to improve its own response to shortages. The other is a proposed rule that requires all manufacturers of certain important prescription drugs, as well as biologics, to notify the FDA of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt supplies. The plan was made in response to an order from the Obama administration two years ago to resolve the shortage problem. Between 2005 and 2011, the number of new shortages quadrupled to 251. Although the figure fell to 117 last year, more than 300 ongoing shortages existed as 2013 got under way. The FDA Safety and Innovation Act also requires the agency to improve its response. The shortages, as you may recall, have reverberated in different ways. Several US Senators blamed pricing by group purchasing organizations. Shortages fed greater reliance on compound pharmacies, one of which caused the fungal meningitis outbreak. Cancer patients have been dying sooner. The FDA, meanwhile, has been criticized for being overzealous in policing plants (read here, here and here). And so, the agency proposed several ideas, including revising procedures so different FDA units respond more effectively; improve agency databases so tracking is more efficient, and finalizing a proposed rule for clarifying the responsibilities drugmakers have to notify the FDA of a discontinued produ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs