FDA: Product quality issues fuel rise in drug shortages

"A very large number of quality product issues" is what Valerie Jensen, associate director for FDA's drug shortage program (CDER), cites as the major cause of the 178 shortages counted by the regulator in 2010. To be precise, product quality played a role in 54% of shortages. Some of the issues were sterility or impurities; others were production delays or capacity problems. "In 2011, we're seeing the same trend." Story