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Watchdog Group Calls for Closer Scrutiny of Compounding Pharmacies

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December 6, 2012 – In the wake of a nationwide fungal meningitis outbreak that has sickened more than 500 people – including at least 36 individuals who died as a result of their illness – the consumer watchdog group Public Citizen has called for an immediate re-inspection of any compounding pharmacy that has previously received a warning letter from the U.S. Food & Drug Administration (FDA). The request comes following allegations that federal health regulators were aware of a long history of problems with the New England Compounding Center (NECC), the company identified as the source of this summer’s fungal meningitis outbreak. In response to these events, NECC closed its doors and recalled all the drugs it processed this year.

Compounding Pharmacy Lawsuit Update 11/18/13: A bill that would grant the U.S. Food and Drug Administration (FDA) greater power in policing compounding pharmacies was cleared by Congress today, in what experts said was a critical step to ensuring a safer drug supply. The bill, known as the Drug Quality and Safety Act, was enacted to prevent events like last year’s meningitis outbreak that killed 64 and seriously injured hundreds more.

Compounding Pharmacy Recall Update 8/12/13: Texas-based compounding pharmacy Specialty Compounding, LLC, has issued a nationwide recall for all lots of medications it has processed since May 9. To date, at least 15 people have been diagnosed with a rare bacterial infection after being administered injections of calcium gluconate at a pair of Texas hospitals. In response to this and a number of other recent compounding pharmacy recalls, the FDA is asking Congress for increased oversight and authority over these operations.

Fungal Meningitis Update 1/30/13: This week, a federal judge ruled that assets of the company at the center of last year’s unprecedented fungal meningitis outbreak will be frozen indefinitely. An emergency injunction was placed on the New England Compounding Center (NECC) after the owners were accused of funneling more than $21 million out of the company’s assets before filing for bankruptcy in December.

 

What’s the problem?

In a letter sent last week to FDA Commissioner Margaret Hamburg, Public Citizen urged the administration to investigate any compounding center that has received a previous violation from federal health regulators. The group’s concerns stem from a regulatory loophole that allowed unsanitary conditions at NECC’s plant in Framingham, Mass. to result in the shipment of contaminated vials of a steroid pain reliever to medical clinics throughout the United States.

According to Public Citizen, between 2003 and 2012, the FDA sent warning letters to 16 compounding pharmacies in 15 states. Five of these letters involved patient injuries and deaths linked to drugs processed by the companies. Other letters included allegations of activities that went beyond the scope of compounding pharmacies, which are supposed to be restricted to making customs medications on a per-patient basis.

During the fallout from this summer’s unprecedented fungal meningitis outbreak, the FDA and other regulatory agencies have faced sharp criticism. Although previous inspection reports identified unsafe practices at NECC’s processing facility, the FDA maintains that it did not have the authority to shut the plant down, a claim which some experts and lawmakers have disputed.

“The FDA’s warning letters show that the agency doesn’t need any additional actions by Congress to enforce the Food, Drug, and Cosmetics Act against pharmacies that engage in illegal drug manufacturing,” Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, said in a press release. “By not fully investigating what could potentially be deadly violations of the law, the FDA is disregarding its primary purpose, which is to protect the lives of citizens.”

By the time NECC’s plant was shut down in September, it had shipped approximately 17,000 vials of potentially tainted methylprednisolone acetate to healthcare facilities in 23 states. It has been estimated that about 14,000 patients were injected with the drug as a result.

A subsequent investigation of NECC’s facility uncovered serious problems with sanitation, and found the same fungi that was linked to the outbreak in unopened vials of methylprednisolone acetate. In some vials, there were even visible globs of fungus seen floating in the medication.

Since news of the outbreak first made headlines, a growing number of lawsuits have been filed against NECC in courthouses around the country on behalf of individuals who were injured or died after receiving steroid injections that were processed by the company. However, concerns have been raised about the pharmacy’s ability to properly compensate all of the people who have filed claims.

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