Wednesday, October 10, 2012

Meningitis cases mount as ex-FDA lawyers fault agency for not stepping in

Meningitis cases mount as ex-FDA lawyers fault agency for not stepping in | The Town Talk | thetowntalk.com: "

“The FDA should have put them out of business, and the state should have put them out of business. Neither of them did their job,” said Peter Barton Hutt, who was chief counsel at the agency in the 1970s.

In the wake of the outbreak, lawmakers this week are raising questions about the regulation of the compounding firms and whether the FDA should be given more oversight authority.

However, the FDA already has the power to rein in large-scale drug compounding companies under a 1938 law, Hutt said.

“The statute is clear,” Hutt said. “First, you can’t stockpile under any circumstances, and if there is an approved drug, you can’t compound a competing drug.”"

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