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November 14, 2012 8:59 pm
Lawmakers grilled the head of the US Food and Drug Administration on Wednesday for failing to act on warning signs at the pharmacy at the centre of a deadly meningitis outbreak.
Margaret Hamburg, FDA commissioner, defended the regulator’s actions and called for more authority to oversee compounding pharmacies – which mix and create drugs – warning that without new legislation more fatal public health crises would occur.
More than 400 people have been infected and 32 people have died from a fungal meningitis that spread through epidural steroid injections manufactured in a Massachusetts compounding pharmacy.
“Stronger, clearer authority would allow more effective regulation of the drug compounding industry,” Ms Hamburg told the House energy and commerce committee. “Our authority over drug compounding is unclear, limited and contested.”
Lawmakers at the hearing said the FDA failed to follow up on a 2006 warning letter to the New England Compounding Center that threatened to shut down the pharmacy because of alleged packaging violations. Ms Hamburg said it was unclear if the FDA actually had authority to shut the pharmacy down.
“Leadership is easy if you are willing to accept it and you are not,” Tim Murphy, a Pennsylvania congressman, told Ms Hamburg.
John Dingell, a congressman from Michigan, said the FDA failed to use its power to determine that the pharmacy was actually a manufacturer and scolded Ms Hamburg for being defensive.
“I would assure you that you’re putting your head in a noose,” Mr Dingell said.
Last week the head of the Massachusetts pharmacy board was fired for failing to act on complaints that the New England Compounding Center was shipping drugs to hospitals in Colorado without specific prescriptions.
Barry Cadden, co-owner of the New England Compounding Center, attended the hearing on Wednesday but refused to testify, citing his fifth amendment right to silence.
In the US, state pharmacy boards regulate compounding pharmacies, which are intended to create small doses of specialised medicines. In recent years such pharmacies have escalated their operations to effectively become drug manufacturers that operate outside of the FDA's jurisdiction.
Ms Hamburg on Wednesday called for new powers that would require compounding pharmacies to register with the FDA, submit test samples of their drugs, provide clear labelling about the source of their ingredients and report any problems drugs to the agency, as big manufacturers are required to do.
Meningitis is a potentially fatal infection of the membranes that cover the brain and spinal cord. Symptoms include headaches, stiffness and numbness.
“We have lived a nightmare,” Joyce Lovelace, whose husband died of meningitis after receiving a contaminated injection, told the committee. “I want people to know what kind of person has perished because of their lack of concern.”
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