“FDA’S CONTRIBUTION TO THE DRUG SHORTAGE CRISIS” — A HOUSE OF REPRESENTATIVES STAFF REPORT (6/15/12)

The U.S. House of Representatives Committee on Oversight and Government Reform recently published a 21 page staff report document that was highly critical of the FDA.  Several of you had requested information regarding this report since you were interesting in reading the report that caused the FDA response.

Enclosed below are several of the key findings.  While these are summarized, please form your own opinion by reading the entire document.  I believe that you will note that inherent biases exist within this document with which you may agree or disagree.

“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.” 

Comment

Please note that the increase between 2010 and 2011 cannot all be attributed to Warning Letters that related to either CBER or CDER activities.  Please review both this document and FDA’s response to learn why this increase may “bend the truth”.

“In response to FDA prodding, companies producing generic injectable drugs have taken their manufacturing off-line simultaneous to other generic competitors also going off-line. These simultaneous shut downs diminish the ability of competitors to offset shortages with increased production. Prior to these actions, 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, 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.”

COMMENT 

Evidence exists that  consumers have been injured or even killed by various drugs/devices.  The staff committee putting this report together did not “do their homework” in this area.  Please visit previous Blogs relating to H&P Industries (Triad Group) to learn of FDA (CDER) activities to include a seizure relating to the finding of Bacillus cereus within sterile gauze pads.

The entire report may be found at: http://oversight.house.gov/wp-content/uploads/2012/06/6-15-2012-Report-FDAs-Contribution-to-the-Drug-Shortage-Crisis.pdf