Deadly fungal meningitis outbreak linked to MA compounding pharmacy

Texas drug defect attorneys: continued from part 1

What does a compounding pharmacy do?

The growing outbreak of a rare, but deadly, form of meningitis has been linked by investigators to contamination of a steroid manufactured by the New England Compounding Center (NECC). The Texas drug defect attorneys at Denena & Points clarify that the NECC is one of many compounding pharmacies nationwide that takes manufactured drugs and re-mixes them into other, individualized prescription forms.

Compounding pharmacies, for instance, might change the dosage of a drug, remove an allergen to which some patients are sensitive, add a flavoring to make a medicine more palatable, change a drug from a pill form to a liquid, or add a bulk ingredient to a manufactured medication.

Compounding pharmacy drugs are exempt from FDA approval and safety oversight

Patients might not realize that almost 10% of prescription drugs used in the United States come out of the compounding pharmacies. Our Texas drug defect attorneys point out that drugs mixed by these compounding pharmacies are not required to undergo the FDA pre-market approval process. Instead, compounding pharmacies are licensed and overseen by the individual U.S. states’ pharmacy boards.

Drug manufacturers in the United States, including compounding pharmacies, often rely heavily on foreign labor imported under U.S. visa programs such as the H-1B visa. And a visa website indicates that NECC apparently had at least two labor certifications (the certification underlying permanent foreign residence green card applications) approved around 2004.

While the risks posed to patients by drugs manufactured by compounding pharmacies and not receiving FDA approval have been known for some while, shortages of needed drugs have led physicians to seek alternatives. One of the best alternatives to ensure availability of required drugs has been use of the state-licensed compounding pharmacies.

Our Texas drug defect attorneys understand that nationwide, many drugs are back-ordered or out of stock. So hospitals, clinics, and doctors have been looking to the compounding pharmacies to fill the gap. Compounding pharmacies have also been a good source for custom-made medications that “name” manufacturers have discontinued due to lack of profitability. Currently, the U.S. has about 7,500 compounding pharmacies. This number is up substantially just since 2009, when there were only about 5,000 in operation.

Because compounding pharmacies do not manufacture “new” drugs, but only derivative or re-mixed drugs, they are exempt from FDA oversight. They operate under state pharmacy board oversight only. And the state boards do not generally have the budget, personnel, in-depth knowledge, or time to rigorously supervise the companies’ production processes. The FDA only steps in if there’s a problem with a compounding pharmacy or its products.

Federal investigators only step in when a dangerous problem occurs with compounded drugs

Of course, now there’s a BIG problem with NECC and its steroid product that has been found with fungal contamination. And the FDA has been busy for a week investigating the cause of the contamination and resulting outbreak of deadly fungal meningitis.

U.S. health inspectors began their inspection of the NECC plant in Framingham, MA this past Monday and found contamination in sealed vials of the steroid. After federal investigators tested one of the sealed vials, they found the contaminant to be fungus. Investigators have since determined that two types of fungus might be involved in the outbreak. Our Texas drug defect attorneys note that the federal investigation of NECC, its operations, and the outbreak is still in process.

Continue to part 3 to learn about NECC’s record of violations.