Tuesday, November 20, 2012

House Republicans to FDA: no meningitis action without documents

November 19, 2012 03:56 PM
 Republicans on a congressional panel investigating a deadly meningitis outbreak linked to tainted drugs have told the top U.S. drug regulator not to expect new authority to prevent future problems until the agency hands over documents about its role in the current crisis.
As the number of meningitis cases edged toward the 500-mark, the House of Representatives Energy and Commerce Committee's Republican majority staff released on Monday a letter that gave the Food and Drug Administration until the end of November to comply with a document request first made in mid-October.
"We need these documents to identify any possible weaknesses in FDA's regulatory system that can be immediately corrected administratively or legislatively," said the letter, dated November 16 and addressed to FDA Commissioner Margaret Hamburg by four Republicans, including committee chairman Fred Upton.
"This committee has a long history of thoroughly and deliberatively investigating problems and offering solutions. We cannot and will not be in a position to do so in this case until we have a full accounting," the letter said.
FDA officials had no immediate comment.

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