With news of deaths associated with compounded drugs created by New England Compounding Center reaching a feverous pitch, the risk of compounding drugs and the role of the Food and Drug Administration (FDA) in the production of these drugs is up in the air. Compounded drugs created to reduce the risk of premature labor were found at the compounding center. The compounded drug was created as an affordable alternative to Makena, an FDA-approved drug. The FDA does not approve compounded drugs, which are supposed to be produced on a case-by-case basis for individual patients.
At the heart of the New England Compounding Center scandal are deaths of patients who used methylprednisone injections compounded by the center. The injections were found to contain fungus that caused death. The patients that survived the injections are now being treated, but treatment is painful and may include multiple hospital stays. While there are no reports of pregnant women being affected by the fungal infection, the problem at New England Compounding Center brings to light a loop hole the size of the planet Earth in FDA policy.
When it comes to use of compounded drugs during pregnancy, the drug Makena is at the heart of the debate. Originally, the drug was priced at ,500 per dose – far too much for state Medicaid programs to cover. After debate and communication with the FDA, the company that owns the drug reduced the price to 0 per dose, but that was still too much for most Medicaid programs. Compounded versions of the drug were made available by compounding companies like New England Compounding Center for a fraction of the cost. In some states, Medicaid required proof the pregnant patient had tried the compounded version before covering Makena. The FDA does not consistently review manufacturing centers, drug concentration or sterile conditions in which the compounds are supposed to be formulated. According to Makena, these rules and lack of FDA control over the compounding process leave pregnant women at risk.
Pregnant and non-pregnant patients rarely have any idea where medications are sourced. There is a good chance many medical patients have been treated with compounded drugs never approved by the FDA on at least one occasion.