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I used to work for a pharmaceutical consulting firm, and as soon as George W. Bush became president, the FDA pulled 'way back on random investigations of pharma manufacturers. There were some really scandalous things going on, and I kept sending information to various biotech reporters around the country, none of who saw fit to cover the story. (They kept telling me they "couldn't believe" manufacturers would do anything that might actually put people at risk. You know, the Ronald Reagan philosophy.) Oh well!
Anyway, so I'm a little jaded when it comes to Big Pharma -- or in this case, Baby Pharma. I wonder whether this regulation was being enforced -- and who was governor when they pulled back on it (or, as is even more likely, simply stopped hiring enough inspectors to enforce it):
Authorities in Massachusetts have been accused of failing to properly enforce regulations aimed at protecting patients from contaminated drugs, after the death toll from an outbreak of meningitis linked to a medicine made in the state rose to 14.
The specialised compounding pharmacy at the centre of the escalating health scandal is being investigated for breaches of state and federal laws.
A patient from Minnesota, one of almost 14,000 patients at risk of contracting the disease after being injected with the potentially tainted steroid produced by New England Compounding Center, has filed what is expected to be the first of many lawsuits against the company.
Now state agencies are facing questions over their enforcement of existing regulations. On Friday, a congressional committee called on the state’s pharmacy regulator to provide information about its oversight of the company.
Massachusetts is one of just 17 states with regulations designed to protect patients from the sort of health scare which has now spread to 11 states. Two former compounding pharmacists who now work in the quality control industry told the Guardian that the risk to patients would have been minimal had the regulations, known as USP 797, been enforced.
“It’s abysmal that the local authorities are calling for greater oversight” said Eric Kastango, a committee member of US Pharmacopeia (USP), the industry body behind regulations governing compounding sterile drugs. “If someone just enforced Massachusetts law, these cases could have been avoided. They failed in their responsibility for enforcing what they already had.”
[...] Each case has prompted calls for federal oversight of the drug-producers, which are not subject to the same controls as mass manufacturers but whose regulation falls between the state board of pharmacy, the state department of health and the Food and Drug Administration, which regulates the pharmaceutical industry.
Kastango questioned how closely the state board of pharmacy had inspected NECC’s books and said that the regulations adopted by the state to protect patients, if properly applied, should have avoided contamination.
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