By Michael Collins
Thursday, May 9, 2013
WASHINGTON A top administrator with the U.S. Food and Drug Administration warned today that a deadly meningitis outbreak 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.
More details as they develop online and in Friday’s News Sentinel.
continue reading here
“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.
More details as they develop online and in Friday’s News Sentinel.
continue reading here
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