Your School. Your Paper. Since 1936.

The Suffolk Journal

Your School. Your Paper. Since 1936.

The Suffolk Journal

Your School. Your Paper. Since 1936.

The Suffolk Journal

FDA needs more power

FDA+needs+more+power

Chris Musk  Journal Staff

New England Compounding Center (NECC) – a Framingham, Massachusetts based company – has been distributing a steroid to patients across the United States for various medical reasons. The last shipment of these steroids sent out by NECC has apparently gone to 23 states and 73 medical facilities that could affect up to a total of 14,000 people, according to government health officials.

This steroid has now been confirmed to have infected people in over 14 states, with 205 cases being recorded, and so far 15 deaths from fungal meningitis. NECC has recalled their products sent out and for the time being, suspended production. For those who do not know, meningitis is an infection of the membranes covering the spinal cord and brain, where symptoms can include nausea, headaches, and fevers. Luckily fungal meningitis is not contagious: only the bacterial and viral forms of meningitis are.

How does such a thing like this happen when we have government programs like the FDA overseeing all of the drug makers in America? Many patients have individual needs for specific mixtures of medications; the process of mixing medications to fit each patient’s drug prescription is the process known as drug compounding. The process of drug compounding is performed by many pharmacists, but requires a doctor to physically oversee the pharmacist in making these prescriptions.

The batch of steroids released by New England Compounding Center was not overseen by the FDA because the FDA does not have legal jurisdiction to regulate “drug compounded” medications, but rather only normal medications given to patients. As one can tell, clearly something went wrong in the drug compounding process and the FDA should immediately be given congressional approval to regulate this process before another deadly outbreak happens again.

Tennessee, out of all the states affected, has suffered the worst repercussions from this horrible tragedy, with 53 cases of meningitis and six deaths. Michigan has been the second hardest hit state, with 41 cases and three deaths, followed by Virginia with 34 cases and one death.

Many other states affected by this outbreak – including my home state of New Hampshire and the ones listed above –  have filed for administrative hearings with possible violations to come for New England Compounding Center.  NECC is likely to lose to their license in the state of Massachusetts for giving patients drug prescriptions and I would not be surprised if we start seeing some of those physicians and doctors who work there being arrested. It would be completely unacceptable for the doctors and pharmacists at NECC to get away with any of these offenses.

Some of New England Compounding Center’s patients who have been diagnosed with fungal meningitis have already filed lawsuits against the company. With a total of 15 deaths and hundreds affected by these drug compounded steroid medications, I believe the question is not whether people will be going to prison, but how long are these NECC pharmacists and doctors going to prison for.

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FDA needs more power