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FDA official tells Senate panel meningitis outbreak will recur unless oversight approved

On Behalf of | May 29, 2013 | Fungal Meningitis

File photo provided by the Minnesota Department of Health are vials of the injectable steroid product in Minneapolis made by New England Compounding Center implicated in a fungal meningitis outbreak. Michigan’s attorney general announced Tuesday, March 26, 2013 he is seeking a criminal investigation into the deaths of 17 residents from contaminated steroids supplied by a Massachusetts pharmaceutical company. He said Michigan leads the country in patients affected by the fungal meningitis outbreak. (AP Photo/Minnesota Department of Health, File)

WASHINGTON  A top administrator with the U.S. Food and Drug Administration warned today that a deadly meningitisoutbreak like the one that killed 55 people, including 15 in Tennessee, last year will happen again unless the agency is given the authority to regulate compounding pharmacies that mass-produce drugs and ship them across the country.

“If, in fact, action is not taken, this will happen again,” said Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research. “It’s not a matter of whether. It’s a matter of when.”

Woodcock told a Senate panel that legislation proposed by U.S.Sen. Lamar Alexander, R-Tenn., and others is “a huge step in the right direction.”

The bill would give the FDA the authority to regulate compounding manufacturers that make sterile products without a prescription and sell them across state lines.

Right now, traditional compounding centers, which fill special orders placed by doctors for individual patients, are overseen by state pharmacy boards, but the FDA can step

in when problems arise. But large compounding centers that mass-produce drugs fall into a grey area in which it is not clear who has regulatory authority.

Health officials identified a Massachusetts facility, the New England Compounding Center in Framingham, as the source of contaminated injections that led to last year’s meningitis outbreak.

The Centers for Disease Control and Prevention said Monday that 741 people were sickened and 55 died as a result of the contaminated drugs. In Tennessee, 152 people became ill, and 15 died.

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