New allegations arise in compounding scandal

As state officials seek cover in the scandal over the deadly meningitis outbreak tied to New England Compounding Center, the Massachusetts governor is claiming that the company may have misled state and federal officials about how extensive its operations were.

Gov. Deval Patrick said, "What they were doing instead is making big batches and selling them out of state as a manufacturer would, and that is certainly outside of their state license," according to CBS News.

The Boston Globe says Massachusetts regulators have required the rest of the compounding pharmacies in the state to sign an affidavit stating that they are following state regulations and not "mass-producing" drugs.

More than 130 people in 11 states have now contracted a rare form of meningitis, and a dozen have died so far after taking spinal injections of a steroid manufactured by the compounding pharmacy. One of the concerns that has surfaced in the investigation of the outbreak is that some compounders are operating on a national scale without having to meet the same strict FDA regulations that pharmaceutical plants do.

Compounding has traditionally been seen as a service that could provide local doctors specially created drugs for patients with special needs. Compounders are regulated by the authorities in their states. After the outbreak was discovered, the FDA and the Centers for Disease Control and Prevention were brought in by several state health agencies to help get to the bottom of the problem. New England Compounding Center is recalling all of its products and has voluntarily ceased operations, as has a related compounding company.

The extensiveness of its operations is likely to bring renewed efforts toward oversight of at least large compounders, something previously attempted by the FDA but which the industry deflected with litigation.

- read the CBS News story
- get more from The Boston Globe

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