Tuesday, May 22, 2018

Mass. governor proposes new compounding pharmacy rules

BOSTON — New laws to strengthen state control of compounding pharmacies were proposed Friday by Gov. Deval Patrick, in hopes of preventing another public health disaster like the current outbreak of meningitis caused by a contaminated drug made in Massachusetts.

The new laws will be among the strongest in the country, said Kevin Outterson, a law professor at Boston University and a member of the expert panel that advised the state on how to curb abuses by companies like the New England Compounding Center, the Framingham pharmacy that made the tainted drug responsible for the nationwide meningitis outbreak.

The legislation would establish strict licensing requirements for compounding sterile drugs; let the state assess fines against pharmacies that break its rules; protect whistle-blowers who work in compounding pharmacies; and restructure the state pharmacy board to include more members who are independent of the industry and fewer who are part of it.

Alex Loftus, a spokesman for the state secretary of health and human services, said that Patrick expected the new legislation to be passed quickly.

Daniel Carpenter, a professor of government at Harvard, said the proposed laws seemed sound and comprehensive. But he warned that if other states did not take similar steps, compounding pharmacies engaging in shoddy practices would just move to places with the weakest laws and the least oversight.

The meningitis outbreak, first detected in September, was caused by contaminated batches of a steroid, methylprednisolone acetate, made by the New England Compounding Center. As of Dec. 28, at least 656 people in 19 states, including Florida, had become ill with meningitis or other infections, and 39 have died.

The New England Compounding Center was shut down, and inspections found extensive contamination. Investigations uncovered a long history of questionable practices that had drawn warnings from the state and the Food and Drug Administration. On Dec. 21 the company announced that it had filed for bankruptcy. Numerous lawsuits have been filed against it.

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