FDA strategies to prevent and respond to drug shortages: Finding a better way to predict and prevent company closures

摘要

In the first 2 months of this year, the FDA, reacting to shortages of the critical cancer drug doxorubicin HC1 liposome injection (Doxil) took two emergency steps to boost supplies. First, it allowed Ben Venue Laboratories to use an alternative, unapproved manufacturing process to distribute one lot of Doxil. The FDA provided that limited approval via a consent decree. Ben Venue, which had been making the brand-name sterile injectable drug for Janssen Research, had closed its manufacturing lines in November 2011 because of quality problems. The FDA consent decree allowed Ben Venue to reopen some of those lines, although the exact terms of the decree were not explained.