From the Editor: Quality Systems Lessons from NECC

Is the risk of operating unsafely ever worth the short-term reward?

By Agnes Shanley, Editor in Chief

The tragic outbreak of fungal meningitis, caused by contaminated steroid injections, has focused the world’s attention on a number of serious failures in the U.S. healthcare system. To date, 460 cases of the disease have been reported in 19 states, and 32 people have died extremely painful and completely unnecessary deaths.

Experts have traced the problem to unsafe manufacturing conditions at New England Compounding Co. (NECC), a large pharmaceutical compounder in Massachusetts. The plant inspection reports were grim, describing the visible presence of mold and extremely unsterile conditions for a facility making injectables.

They also revealed that product lots were being released without being tested and that QC data was not being documented.

NECC’s CEO refused to respond to congressional questions. But there’s plenty of blame to go around. U.S. representatives blasted FDA Commissioner Margaret Hamburg, referring to her as the “grand poobah of FDA,” for the Agency’s failure to oversee compounders. She, in turn, described a paralyzing maze of conflicting state and local regulations.

Doesn’t the real blame for this situation rest with Medicare and insurance payers, whose reimbursement practices have created a shadowy space where compounders can manufacture drugs without following FDA regulations? Today, Big Pharma companies must follow current good manufacturing practices (cGMPs) and other stringent requirements for sterile process and equipment validation, all designed to protect the public.

Compounders, instead, are presented voluntary USP guidelines and a mass of unharmonized state regulations.

In the compounding case, the ingredients for disaster were all clearly there: ambiguous payer coverage, downward price pressure, voluntary controls, lack of standard regulations and the pressure to increase production.

But isn’t this the same situation, on a microcosmic scale, that all drug manufacturers face today? In 2004, USP issued USP 797, guidance for the sterile compounding of injectables. USP also helped establish a Pharmacy Compounding Accreditation Board allowing individual pharmacy compounders to demonstrate compliance with tough newer standards. 

Recently, Pharmacy Practice News magazine reported that less than 20 states have adopted USP 797, while only 162 out of 3,000 compounders are accredited.

Legislators are calling for stricter FDA oversight of compounding facilities.

As far as NECC is concerned, what motivated such a flagrant disregard for basic sterility requirements? One can only assume that there was an overwhelming pressure to push out product. Failing to consider the risks has killed patients and destroyed the firm’s reputation.

Big Pharma’s recent quality systems failures have not resulted in any known deaths (although they have caused adverse effects in patients, many of which were never investigated). But does that mean that pharma can’t learn from NECC’s problems? Can Big Pharma afford to cast the first stone? Most recent cGMP 483s and Warning Letters have covered injectables, and problems in some reports haven’t been all that different from NECC’s.

Our cover story this month examines pharma’s chronic cGMP failures, as reflected in recent FDA reports.

One consultant, who asked not to be named, says, “The breakdowns we are seeing today are not sophisticated failures. They are fundamental, and represent the same type of failures we saw in the early ’80s, when nearly 70 percent of ethical pharma was under Warning Letter and Consent Decree.”

Has Big Pharma’s quality culture changed in the past 35 years? Can we say that management supports QC when Hospira’s CEO was quoted last year as calling 483’s “a normal part of doing business?” Perhaps nobody is too good, or too big, to learn from quality systems failures. As NECC has reminded all of us, in a terrible way, patient’s lives — our lives — are at stake.

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