User:Euclid1/sandbox

Key findings of the U.S. House of Representatives Committee on Oversight and Government Reform demonstrated the widespread shortages of generic injectable medications are due in part to increased FDA enforcement and regulation, which has shut down a substantial amount of manufacturing capacity. In 2009, Margaret Hamburg became FDA Commissioner. Between 2009 and 2010, the number of warning letters sent by the agency increased 42%. Between 2010 and 2011, the number of warning letters sent by the FDA increased an additional 156%. In many cases, warning letters have resulted in companies agreeing to take manufacturing off-line to address FDA criticisms. These market exits have resulted in a 30% decrease in manufacturing capacity at America’s primary production facilities for generic injectable drugs. This decrease is a massive reduction in the industries’ capacity to supply the nation with injectable medications. The Committee could not find any evidence that any of the products produced at the facilities undergoing remediation had harmed anyone. Based upon the Committee’s investigation, it is clear that over the past three years the FDA has failed to protect adequate drug supply in efforts to remedy manufacturer problems.