Meningitis outbreak plagues pharma industry

Regulators want more oversight of compounding pharmacies and regulation parity with drug manufacturers

Amy Swinderman
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FRAMINGHAM, Mass.—In early October,the U.S. Centers for Disease Control and Prevention (CDC) beganinvestigating a deadly, multistate outbreak of fungal meningitis andother infections among patients who received contaminated steroidinjections, eventually tracing the outbreak to fungal contaminationin three lots of medication used for epidural steroid injections.Although the outbreak was traced to a compounding pharmacy that fellunder state regulation—but not oversight by the U.S. Food and DrugAdministration (FDA)—the bad press is fueling negative perceptionsabout Big Pharma, as it has recently experienced its own productrecalls or manufacturing facility inspection problems.
Although headlines have erroneouslycited Big Pharma as the cause of the outbreak (Example: "BigPharma-Induced Meningitis Outbreak in U.S. Now Kills 23 as Death TollExpected to Rise," published on the Truth Frequency Network'swebsite), the medication was packaged and marketed by the New EnglandCompounding Center (NECC), a compounding pharmacy in Framingham,Mass. Compounding pharmacies fill special orders placed by doctorsfor individual patients and are typically small operations. However,some pharmacies like the NECC have grown into much larger businessesin recent years, supplying bulk orders of medicines to thousands ofdoctors and hospitals across the country.

Doses from three lots had beendistributed to 75 medical facilities in 23 states. At press time, theoutbreak claimed 29 lives, involved outbreaks in 19 states andaffected 395 people. The form of meningitis is not contagious.

Although no cases of infection reportedwere associated with any other lots of medication, all lots of allmedications distributed by NECC were recalled in separate actions byNECC and regulators. Subsequent analysis identified somecontamination in other lots.

Inspectors from both the FDA and theMassachusetts Department of Health have reported unsterile conditionsat the NECC, including green and yellow residues, water droplets andstanding water in its facilities.

The FDA, which has previously attemptedto exercise its authority in cases where major problems have arisen,but met with federal court opposition, said last month that new lawsmay be needed to clarify the federal government's role inoverseeing compounding pharmacies. Congressional lawmakers havecalled for hearings to examine how the outbreak could have beenprevented.

This heightened government interest hasgarnered a lot of commentary from various news agencies. KentSepkowitz, an infectious-disease specialist in New York City, wrotefor the Daily Beast: "It turns out that the meningitistragedy has revealed a previously obscure fault line, a Hatfield andMcCoy-level nastiness between standard pharma and the curious worldof the compounders over the issue of regulation." He added,"However, neither side of this particular family feud is at allattractive."

Some analysts and industry experts,though, have commented on the outbreak's unintended negative impacton Big Pharma, noting that the problems arose from the NECC'sfacility problems and an insufficient lack of FDA oversight.

Jeff Schweitzer, a scientist and formerWhite House Senior Policy Analyst, commented on the HuffingtonPost, "the meningitis outbreak is such big news because as ageneral rule, the FDA regulates the pharmaceutical industry withsufficient vigor that routine audits typically uncover problemsbefore they impact patients, so that these problems are rare."

In fact, Schweitzer noted, "the dirtylittle secret in the pharmaceutical industry is that drug companieswelcome FDA oversight. The process of drug development is long andexpensive, costing more than a billion dollars and taking more than adecade to bring a new drug to market. No company or investors want torisk this by bringing to market a drug that is ultimately ineffectiveor dangerous; or using manufacturing techniques that riskcontamination."

Amy Swinderman

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