A new report from the House Committee on Oversight and Government Reform blames FDA for shortages of generic injectable medications.
Chairman Darrell Issa (R-CA) says a committee investigation learned that FDA regulatory activity has effectively shut down 30% of manufacturing capacity at four of the largest US producers of generic injectable drugs.
Issa says FDA commissioner Margaret Hamburg and the agency have failed to ensure that its enforcement methods avoid “unnecessary shortages.”
The report notes that between 2010 and 2011, there was a 156% increase in FDA Warning Letters. “Warning letters have resulted in companies agreeing to take manufacturing off-line to address FDA criticisms,” it says. “Bedford Laboratories, Hospira Pharmaceuticals, Sandoz Pharmaceuticals, and Teva Pharmaceuticals were producing nearly one billion units of generic injectable products per year. Facilities at these companies are currently operating at about 700 million units per year. This decrease is a massive reduction in the industries' capacity to supply the nation with injectable medications.”