It’s hard to accept that 29 patients have now died and 338 are sick across 18 states from meningitis because the injectable steroid medications they were administered for pain were contaminated with fungus. The drugs were prepared by the New England Compounding Center (NECC) and shipped across the United States. After the outbreak, an FDA investigation showed in the first nine months of the year, NECC’s so-called “internal monitoring program” showed mold or bacterial contamination at more than 80 locations, including numerous places in its “clean rooms” where sterile drugs are made. In more than half the cases, the company’s own testing showed bacteria and mold above its “action” limits, but NECC took no action.
It gets worse. After the steroid was recalled, the FDA also found that 83 vials from one lot of the tainted steroid contained “greenish black foreign matter.’’ Another 17 vials had white material floating in them. Further testing found that another 50 out of 50 vials from the same lot had “viable microbial growth.”
A lot of people are asking how this could have happened. Indeed, the outbreak raises many difficult questions – how could the system of regulation and oversight patients have come to rely on have broken down so completely? How could patients have been injected with obviously contaminated drugs? What happened to the internal oversight at NECC? Why didn’t someone on staff at NECC blow the whistle before these drugs were shipped? Why wasn’t the Board of Pharmacy in Massachusetts conducting the oversight needed to make sure a compounding pharmacy like NECC was maintaining safe practices? Why didn’t the FDA have jurisdiction to oversee what was clearly drug manufacturing, not simply drug compounding?
NCL’s concern is with the 14,000 patients who received the injectable drugs, those who are sick from meningitis and the families of those who have died from the outbreak. We issued a fact sheet and press release in the last week asking these questions, providing information for patients, and calling for legislation to ensure proper regulation of compounding pharmacies.
We’ve learned a lot about the compounding pharmacy industry. NECC is part of the International Academy of Compounding Pharmacists (IACP), the industry’s Texas-based trade association, which until this disastrous NECC outbreak, has argued that existing regulations are more than adequate to protect patients.
The FDA in 2001 testified before at a US Senate hearing that the agency surveyed drugs from 12 compounding pharmacies, including hormones, antibiotics, steroids and drugs to treat glaucoma, asthma and erectile dysfunction and ten of the 29 drugs failed one or more quality tests, including nine that failed potency testing, some with less than 70 percent of their declared potency. By contrast, in its analyses of more than 3,000 samples from drug manufacturers, who are subject to FDA oversight, only four had quality problems.
Even after the FDA testified about its findings, Congress killed legislation to give the agency oversight on pharmacy compounding. It was the first in a series of failures to regulate a clearly problematic industry, one that had managed to fight its way out of effective regulation through lobbying and political donations.
In a recent article, one patient group provided this quote about IACP: “They mobilize their members, they scare patients and parents, and they flood Capitol Hill,” said Sandra Fusco Walker, director of patient advocacy at Allergy & Asthma Network Mothers of Asthmatics. “They are dedicated to making sure they never have FDA oversight.”
In the coming months, NCL will be on the front lines on behalf of patients to see that what happened in the shipping and administration of contaminated drugs is never allowed to take place again. We are working with Congressman Edward Markey (D-MA), a member of the House Energy and Commerce Committee, which has jurisdiction over the FDA and health issues generally. The Congressman, a longstanding champion of consumers and patients, has introduced a bill to close the gaping hole in regulation of compounding pharmacies.