Compounding Crisis Continues as Reports Raise Questions of Quality

| 15 October 2012

US regulators continue to scramble to understand the extent of a meningitis outbreak linked to a compounding pharmacy in Massachusetts as the death and infection count continue to rise day by day-an unfortunate side effect of a disease with an incubation period that can last months.

(Reuters) - The Centers for Disease Control and Prevention has confirmed more than 15 deaths and 200 cases of meningitis from steroid injections manufactured by the New England Compounding Pharmacy, with cases expected to rise. More than 13,000 patients were potentially exposed to the contaminated drug, which was used to treat back pain.

(Wall Street Journal) - The differences between pharmaceutical compounders and drug manufacturers has increasingly become blurred, with many companies producing compounds far beyond the scale of traditional compounding pharmacies. The scale quickly overwhelmed state regulators, who have regulatory authority over their operations-not the US Food and Drug Administration (FDA).

(Wall Street Journal) - What's more, those compounders have actively fought the implementation of new controls, saying they are already sufficiently regulated and that the FDA has some oversight over their operations.

(Reuters) - The House Energy and Commerce Committee is expanding the course of its investigation into the scandal, moving on 11 October to request information from the Massachusetts pharmacy board regarding its regulation and oversight of the New England Compounding Center.

(The New York Times) - A second pharmacy owned by the New England Compounding Center has voluntarily suspended its operations while the FDA investigates the firm. The paper also notes that many former employees of the New England Compounding Center point to serious deficiencies they noticed during their employment, including missing labels, untrained staff and shortcuts meant to save money.

(The Tennessean) - Two senators from Tennessee-the state where the majority of infections and deaths have so far occurred, have written to FDA Commissioner Margaret Hamburg to determine whether the agency took all appropriate actions or whether it needs additional authority to regulate compound pharmacies.

(Boston Herald) - The CDC is struggling to adapt to the meningitis infections, which it concedes is unusual and unlike the virulent or fast-moving targets it is usually tasked with fighting. It is, in essence, a catastrophe in slow motion.

(AP) - One of the owners of the New England Compounding Pharmacy had a background not in pharmacy, but in engineering and recycling.

(Forbes) - US Sen. Scott Brown (R-MA) risks being roped into the scandal by way of a $10,000 check he received from the New England Compounding Center just weeks after he signed a letter the Boston Globe contends was a, "top legislative priority of the compounding pharmacy industry."

(Boston Herald) - The root of FDA's regulatory problems for compounders can be linked to a 2002 court case in which the agency was stripped of its authority based on what essentially amounted to a technicality. Congress, said one expert, could have easily fixed the technicality, but didn't.


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