Avik Roy: How Margaret Hamburg’s FDA Causes Cancer Drug Shortages

One of the most serious problems in American health care today is acatastrophic shortage of supply for dozens of important generic drugs, especially certain injectable medications that form the backbone of modern cancer chemotherapy. As a result of the shortages, many cancer patients today are unable to gain access to basic, life-extending drugs that cost less than a bottle of Coke. Today, the House Oversight Committee released an in-depth report, alleging that a significant cause of this shortage is an out-of-control regulatory smackdown, initiated by FDA Commissioner Margaret Hamburg.

The report, commissioned by Oversight Committee chairman Darrell Issa (R., Calif.), details the dramatic drop in the production of generic injectable drugs since Hamburg was confirmed as FDA chief in May 2009. Upon taking office, Hamburg promised an aggressive effort to enforce the FDA’s stringent manufacturing standards. In 2010, Hamburg’s officials issued 673 warning letters to drugmakers and other companies: a 42 percent increase from 2009. In 2011, the agency issued 1,720 warning letters: a further increase of 156 percent.

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