FDA Gets No Compounder Oversight Without Doc Release: GOP

Law360, New York (November 19, 2012, 7:06 PM EST) -- Republican leaders investigating the recent meningitis outbreak's link to pharmacy compounding have warned the U.S. Food and Drug Administration's commissioner that without extensive internal agency documents, they could not grant the FDA increased oversight over compounders, a letter released Monday said.

FDA Commissioner Margaret Hamburg appeared before the House Energy and Commerce Committee's oversight panel last week to testify about the outbreak, which has been traced to contaminated drugs distributed by a compounder in Massachusetts.

Hamburg told lawmakers that the FDA, which knew about previous problems...
To view the full article, register now.