More Manufacturing Problems, Less Drugs

Sep 16, 2013


Early notification procedures have helped prevent new medication shortages, but the number of ongoing drug shortages has not fallen because quality manufacturing problems persist, pharmacy and hospital sources said. A program devised by the generic drug industry to mitigate shortages has not taken shape because of a lack of manufacturers in the marketplace, but industry is working with FDA on an agency proposal to collect more information about manufacturing quality to prevent future drug shortages.

Early warnings about potential drug shortages — a procedure codified in last year’s FDA Safety and Innovation Act — has helped FDA prevent new shortages, sources said. The number of new shortages — 86 as of July 31 — is at its lowest level since 2006 and well below a 2011 high of 267 new shortages, according to data from the University of Utah, which tracks the shortages.

The number of active drug shortages, however, remains at high levels. As of the third quarter of this year, there were 302 ongoing shortages — slightly higher than the 282 shortages during the same time last year, according to the University of Utah. Read more.