Opinion

''Bring Drug Compounding Firms Out of the Shadows''

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"The headlines generated last fall by a meningitis outbreak linked to injectable drugs manufactured in filthy conditions may have faded. But Congress is sorely mistaken if members believe that the outrage over this massive pharmaceutical public health disaster and regulatory failure — 749 people were infected, 61 died — has ebbed.

Firms like the New England Compounding Center, which shipped more than 17,000 potentially contaminated vials to more than 20 states, including Minnesota, should not be operating in the regulatory shadows by exploiting the legal leeway traditionally given to Main Street pharmacists to mix (or “compound”) custom medications for clients. Instead, big compounding firms like NECC, whose dirt- and debris-filled facilities shocked investigators and the public, should clearly be subject to federal oversight like other drug manufacturers so that future outbreaks and deaths can be prevented."

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"This week, a critical opportunity to pass the Senate legislation, which is supported by many respected public health organizations, slipped by. Lawmakers had a crowded docket to get through before the summer recess, and the Senate bill failed to progress. The legislation would give the FDA clear authority over large compounding pharmacies that produce sterile products (such as injectable medications) in advance of a prescription and ship it across state lines.

"This bill recognizes that the industry has changed significantly over the last several decades and attempts to mitigate the risks associated with large-scale production of sterile products … This addresses certain high-risk facilities while leaving traditional pharmacy dispensing essentially untouched," wrote Allan Coukell, the senior director for drugs and medical devices for the Pew Charitable Trusts, in a July 29 letter to Senate leaders."

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"The Senate bill contains another critical reform that would enhance officials' ability to track drugs as they move the supply chain — dramatically improving the detection and prevention of counterfeit drugs."

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