Whistleblower Lab Tech Speaks Out on NECC Contamination

When a drug or device manufacturer recalls a product that is injuring or killing people, the typical course of action they take is to convince the public that they did everything in their power to minimize further damage. But who are they actually protecting? Often, it is not until months (or sometimes years) later that we become aware just how much the company knew, and at which point. All too often, we see that the company’s strategy involved concealing information, delaying going public, and hoping to slip under the radar.

On Sunday, March 10, Scott Pelly of 60 Minutes will interview Joe Connolly, a whistleblower from inside the company. Until now, no one from the New England Compounding Center (NECC) would speak out or explain what happened.  Barry Cadden, NECC president, pleaded the Fifth when subpoenaed by Congress.

According to CBS’s preview of the interview, concerns were shrugged off in the month leading up to the meningitis outbreak. Connolly, who worked as a lab technician at the New England Compounding Center, says he warned his supervisor a month before the first Meningitis death that he thought they were going to hurt a patient and get shut down. His supervisor did nothing.

As we said in an earlier post, the FDA monitors and sets guidelines for drug manufacturers. Since the production and distribution of compounded drugs are meant to be on smaller/local scales, compounding pharmacies like the NECC are more loosely monitored by state pharmacy boards. However, many of them have begun to act more like manufacturers, mass-producing drugs and shipping to many facilities in different states. Connolly admits in his interview that the company was acting more as a manufacturer than a compounding facility and got “greedy” and “sloppy.”

The FDA released a list of all facilities who received drugs from the NECC, which includes somewhere near 7,000 doctors and hospitals in the U.S. In 2011, a Denver area hospital filed a cease and desist letter, alleging that the NECC sent compounded drugs into Colorado without valid prescriptions. In 2004 an adverse event involving Methylprednisolone Acetate, the same drug that was responsible for the outbreak, prompted a federal inspection of the facility.

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After inspections of the facility, there is no doubt that this problem was predictable and preventable. Reports revealed air-conditioning ducts, autoclaves and drug vials contaminated with greenish black and white filamentous matter. Even the “clean room” had cracks in it and showed growths of bacteria and mold. However, these conditions do not appear to be the result of any lack in finances. According to Boston Globe, the four family members who cofounded NECC in 1998 paid themselves a combined $16 million last year.

The state of Massachusetts found NECC’s lab to be in satisfactory  condition after a 2011 inspection. However, in an upcoming CBS broadcast, another company insider will talk about how the NECC concealed its operations from inspectors.

Visit our website for more information on the contamination, outbreak, and litigation involving the NECC and distributors.

Regulating Drug Compounding Pharmacies

The recent meningitis outbreak has exposed some major regulatory flaws in compounding pharmacy practices. After 39 (to date) tragic deaths, and many more confirmed cases, we are left with some pressing questions:  Why did this happen? Who is responsible? How could this have been prevented? What changes do we need to make for the future?

The FDA is pushing for new legislation that would increase their authority over some types of compounding pharmacies. Although it is generally agreed upon that the current system in place needs to be changed, not everyone is in favor for what the FDA has in mind.

CDC scientist Naureen Iqbal reads results of antifungal drug susceptibility testing during the multistate meningitis outbreak.Click Image to visit original source - CDC

CDC scientist Naureen Iqbal reads results of antifungal drug susceptibility testing during the multistate meningitis outbreak.
Click Image to visit original source – CDC

The Problem

Compounding pharmacies are meant to serve the individual needs of patients by altering or mixing drugs for a specific prescription. Although the drugs they use and alter are FDA-approved, the compounding process is not subject to FDA regulation.

In their pure form, compounding pharmacies play an important role in patient treatment. However, lack of oversight creates inherent potential for abuse. As the FDA has realized, some facilities have set up shop in the guise of compounding pharmacies, when really their operations are closer to those of manufacturing facilities. That is, they mass produce and distribute certain drugs for reasons other than filling a specific need of a patient. For all intents and purposes, they function as manufacturing companies but without the burden and cost of meeting FDA standards.

Compounding pharmacies are subject to state regulation. The FDA has the authority to step in when compounding pharmacies are breaking legal limits, but they have been too slow to take measures against these practices in the past. As a result, these facilities have fallen into a gray area between state law, which governs the compounding pharmacies, and federal law, which governs manufacturing companies. The New England Compounding Center, which distributed its recalled products to clinics in at least 23 different states, is considered to be in this “gray area” and the FDA is being criticized for not stepping in early enough.

The Proposed Solution:

At a meeting with state pharmacy regulators, FDA Commissioner Margaret A. Hamburg summarized a proposal that would essentially divide compounding pharmacies into two categories – smaller, “traditional” compounding pharmacies and larger pharmacies that often produce mass amounts of a compounded drug. State law would continue to oversee traditional compounding pharmacies, while the pharmacies with a larger distribution would be operate under federal standards.

Problems with the Solution:

Although the proposed federal standards would be more stringent than most current state regulations for compounding facilities, they would also be less stringent for large compounders than for drug manufacturers.

Consumer group Public Citizen denounces the FDA’s proposal, arguing that it would not strengthen existing laws, but rather “legitimize current abuses to the system and put the public at risk.”

They also criticized Commissioner Hamburg for deflecting the blame onto the State of Massachusetts for regulatory failures that occurred at the New England Compounding Center and eventually led to the deadly meningitis outbreak.

The FDA’s proposal will ultimately require congressional approval before it will be implemented. Other than Public Citizen’s evident disapproval, republican leaders in the House seem less than eager to pursue such legislation. They believe that internal memos from the FDA will show that the agency had several chances to shut down the NECC but failed to do so. The FDA’s lack of cooperation in producing the requested documents only increases their suspicions, and they are unlikely to pass anything in favor of the FDA’s proposal until they receive that information.

Although the contents of this post addressed problems in regulation, the overarching injustice here is to the people who have received the contaminated injections produced by NECC. If you or a loved one have received one of these injections, you may be entitled to compensation. Please contact us for a free consultation.

For additional information on the meningitis outbreak, please visit our website.

Sources:

FDA.GOV

Public Citizen

Chemical & Engineering News

NBC News