A congressional committee has stepped into the fray on the New England Compounding Center (NECC), officially questioning whether the company operated more like a commercial-scale drug manufacturer than a pharmacy. With Congress involved, it ups the prospects for legislation for federal oversight of at least large-scale compounding operations.
The level of business done by NECC raises the "question whether the NECC was operating as a traditional compounding pharmacy or on a commercial scale as a drug manufacturer," the House Committee on Energy and Commerce said in a request for 10 years' worth of safety and quality records from the company. The company's products have been tied to a meningitis outbreak that has killed 23 and sickened nearly 300.
Compounders generally serve a local market and create drugs for doctors to treat patients with particular needs, but NECC was selling drugs throughout the country, even handing out "free samples" to doctors, according to a warning letter the company received from the FDA in 2006. While repackagers are generally regulated by states, which is one of the issues raised by the scandal, the FDA was called in to evaluate the company's repacking of cancer drug Avastin. Inspectors found a number of issues and said, "We are especially concerned with the potential microbial contamination associated with splitting Avastin--a single-use, preservative-free, vial--into multiple doses."
The Associated Press also reports that state records it obtained showed NECC signed a consent decree in 2006 with Massachusetts and agreed to inspections by a consulting firm after problems were reported with one of its products. Pharmaceutical Systems Inc. found "significant gaps" in the kinds of procedures the FDA would require if the compounder were federally regulated. For example, it lacked the written documentation that drugmakers must have to show that they have repeatable procedures that guarantee sterility and quality. It also found a hole in a ceiling and a buildup of dirt on some equipment.
But the records show that the state later praised NECC plant upgrades and set aside a one-year probation the company had agreed to as part of a consent decree. It levied no fines or other penalties. In a letter to the FDA, the congressional committee wants to know exactly how long NECC was operating on a large scale and why it was allowed to do so given the issues found at the compounder, the AP reports.
- read the AP story
- here's the FDA warning letter
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