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.

A growing outbreak of fungal meningitis has claimed 7 lives and infected up to 64 people across 9 states. The rate that the outbreak is growing is also alarming:

The total number of cases has also grown to 64 people in nine states, the CDC said. That is 17 more cases and two more states than the day before.

Patients contracted the deadly meningitis after being injected in their spine with a preservative-free steroid called methylprednisolone acetate that was contaminated by a fungus. The steroid is used to treat pain and inflammation.

The steroid is manufactured by compound pharmacies. Compounding is used to create special blends of medications that aren't available on the market, as well as to custom tailor drugs to fit a certain patients needs. According to a 2003 GAO report, nearly 10% of all drugs administered in the Untied States are compound manufactured. But how safe are these drugs? Well it depends on the state they are manufactured in:

Drugs manufactured by compound pharmacies do not have to go through FDA-mandated pre-market approval. Instead, oversight and licensing of these pharmacies comes from state health pharmacy boards.

The steroid causing this outbreak was manufactured by The New England Compounding Center, a pharmacy based in Massachusetts. When federal inspectors did come in to the plant last week, they found unopened vials of the steroid that contained foreign particles. After testing one of these vials, the particle was determined to be the fungus causing this meningitis.

Reading about it, I can't help but think back to the healthcare debate. When the Affordable Care Act was being debated in Congress, one of the issues was allowing people to buy their prescriptions from Canada and other countries. The opponents to that argued that those countries don't have the same safety screenings that our country does. Ironically, I don't recall reading about such an outbreak happening in Canada.

So if we are going to prevent our citizens from getting their medications from Canada, simply because our safety standards are higher, then shouldn't we be sure that is the case? Shouldn't these compound pharmacies be regulated by strict federal standards and not just state regulations? It seems that should be the case. Institute tough oversight and regulations on the federal level, coupled with inspections of facilities, and maybe we wouldn't be talking about this deadly outbreak today.