FDA chief defends approval of hydrocodone drug

March 13, 2014

The head of the Food and Drug Administration says the much-debated painkiller Zohydro fills an "important and unique niche" for treating pain.

Dr. Margaret Hamburg defended her agency's decision to clear the drug during questioning before a Senate committee on Thursday, saying the pill from Zogenix met the government's standards for safety and effectiveness.

Zohydro is the first pure version of hydrocodone, the most abused medication in the U.S. More than a half-dozen lawmakers have criticized the FDA's approval decision, questioning why Zohydro was not formulated to thwart drug abusers from snorting or injecting it.

Hamburg cautioned that such formulations are still in the early stages of development. To date, the FDA has only approved one medication with such features: OxyContin.

"Right now, unfortunately, the technology is poor," Hamburg said.

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