The recent fungal meningitis outbreak, which was caused by contaminated vials and killed over a dozen people, has left many Americans wondering how such a thing could have happened and whether or not their drugs are safe.
A recent article in the New York Times suggests that scarce monitoring of the pharmacy responsible could have created the conditions for the outbreak. Today, many clinics and hospitals are using compounding pharmacies instead of major manufacturers to get their drugs. This is, in part, because the compounding pharmacies charge less than the major manufacturers.
However, the Food and Drug Administration (FDA) has much less oversight in compounding pharmacies than it does traditional manufacturers. Boston law professor Kevin Outterson went so far as to say, “The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts.”
This dangerous oversight allows pharmacies like the New England Compounding Center to operate and develop drugs in unregulated conditions, leading to the possibility of the distribution of unsafe drugs to thousands of Americans. In fact, the New England Compounding Center was permitted to distribute 17,676 vials of the contaminated drug to 23 states.
What is worse is that many of the patients exposed to this unsafe drug may have done so needlessly. According to CNN, medical experts at the Cochrane Foundation examined the data regarding the drug involved in the outbreak in 2011, finding “no strong evidence for or against” taking it. Steroid injections were developed to manage pain, with the hope that these injections would allow the patient to avoid surgery. If the drug is not effective, however, the thousands of Americans who took it were exposed to danger without any chance of benefit to their health.
While compounding centers may have their place in the health care industry—these centers often step in to fill shortages of drugs, for example—it is clear that much more oversight and regulation by the FDA is needed to ensure that the American people are safe from harmful drugs.
If you were harmed by a drug or medical professional, you may have legal options. Contact a Martinson & Beason, P.C. personal injury attorney to learn how we may be able to help you.