Last December, the Justice Department announced the indictiment of the owner/head pharmacist, the supervising pharmacist, and 12 others associated with the New England Compounding Compounding Center. The 131-count indictment, which included 25 charges of second-degree murder, grew out of a 2012 outbreak of fungal meningitis caused by contaminated drugs manufactured by the company. More than 750 patients were diagnosed with the illness as a result, and 64 patients in nine states died from it.
In a February 28, 2015, op-ed in USA Today, CPR President Rena Steinzor, author of Why Not Jail? Industrial Catastrophes, Corporate Malfeasance, and Government Inaction, recounts the story and then takes a look at how policymakers reacted, and what came of their response. The tragedy laid bare a gaping hole in the nation’s regulatory fabric, and rather than addressing it with straightforward legislation and resources to enforce it, Congress pass a “market-based” bill that allowed individual compounding pharmacies to decide for themselves if they’d like to be regulated or not. She writes:
In March 2013, Congress passed bipartisan legislation to fix the problem. Incredibly, though, it allowed compounding pharmacists to decide whether to volunteer to be regulated. Unless they register with the FDA, the agency has no way of knowing about them except through patient and medical professional complaints, a reporting method that in many cases comes far too late. The rationale? Market forces will take care of the problem because no hospital or treatment center will want to deal with an unregistered company.
In January, the Office of the Inspector General at the Department of Health and Human Services issued a report regarding Medicare’s oversight of compounding pharmacies that supply hospitals. Contrary to the optimism of Congress, the report found that as of January 1, 2015, just 26 compounding pharmacies had registered with the FDA. According to the industry’s main trade association, 7,500 community-based pharmacies operate around the country, and 3,000 of that number make sterile preparations. The Inspector General also found that Medicare auditors did barely anything to review how hospitals choose and scrutinize manufacturers of compounded sterile preparations, again because of resource shortfalls and lack of training. So much for Congress’s half-baked fix for the problem.