Compounding Pharmacies Come Closer to Regulation

About one year ago, a fungal meningitis outbreak in New England affected nearly eight hundred individuals in twenty states, claiming over sixty lives in the process. The source of these infections was the New England Compounding Center (NECC) in Massachusetts, which was an active distributor of the painkiller methylprednisone acetate, commonly used to treat chronic back pain.

Since the outbreak began in October 2012, investigators turned up startling findings at labs like the NECC; at one site, inspectors observed 83 vials containing “greenish black foreign matter,” over a dozen more with “white filamentous material,” and general lack of sanitation in labs purported to be (and required by law to be) sterile. In the first wave of probes last winter, about 11 of these pharmacies, which mix personalized doses of medicine for individual patients, were closed due to unsafe conditions. Those who were given injections of these tainted drugs suffered ailments like stroke, central nervous system infections, joint infections, fever, headache, nausea, and slurred speech.

We reported that the Commissioner of the FDA has complained publicly that “[s]ome of the firms we inspect still challenge our authority to conduct full inspections of their facilities. Our inspections have been delayed or the inspectors were denied full access to records at some of the facilities. At least four of our recent inspections were delayed by such resistance; and in two other instances, we had to get administrative warrants from the courts […]. These challenges and others highlight the need for clearer authorities for [the] FDA to efficiently protect public health.”

Of course, this sounds promising: a federal body wants more power to police potentially dangerous drugs coming out of compounding pharmacies. Additionally, in what seems like more good news, the New York Times recently reported that a bill that would grant additional oversight to the FDA in holding compounding pharmacies accountable for such actions cleared the Senate with bipartisan support. One problem is that “the bill […] stops short of giving the FDA complete authority over pharmacies that tailor-mix drugs for individual patients.” The same article claims that eighty percent of hospitals rely upon such companies to mix drugs for their patients.

These individual businesses will be allowed to either opt in or opt out of such FDA regulation. If they opt in, their products will carry a label certifying FDA approval. If they do not, they will not be obligated to allow their records to be seen by federal regulators, who have resorted to obtaining subpoenas in the past to properly evaluate these drug manufacturers for misconduct and unsafe practices.

The International Academy of Compounding Pharmacists, an industry group, released a statement saying that if we want to prevent outbreaks like the one that occurred a year ago, then “the American public must know that this bill will not accomplish that goal,” but they argue that such legislation will allow federal regulators too much control over their practices. A representative of the FDA, on the other hand, claims that this bill is a step in the right direction, but that it falls short of giving the agency the regulatory power and oversight necessary to keep these pharmacies practicing safely: “This doesn’t necessarily preclude the risky practices we’ve seen in recent years. But it’s a big improvement.” While the outbreak has not worsened since February 2013, this bill will help to close at least some of the regulatory gaps that enabled the sickness to spread in the first place, but we should hope efforts for greater oversight do not end there. As we have stated before in this blog, consumers need more — and effective — supervision of drug companies not less.