Cutting the budget for inspections of compounding pharmacies

Fungal meningitis from improperly compounded products at NECC (NEJM article here) killed 55 people and infected more than 600 others (CDC data here). All of these products originated in Massachusetts, but all of the injuries occurred in other states. But Massachusetts felt some responsibility for the failures at NECC, as acknowledged by both Gov. Patrick and the Interim Commissioner of Public Health.  The DPH enacted emergency regulations on Nov. 1, 2012 and the Governor’s special commission delivered a comprehensive set of recommendations.  Both efforts informed the Governor’s proposed legislation in January 2013 and several bills pending in the Massachusetts House and Senate.

In the interim, the Governor boosted the budget for inspections at compounding pharmacies.  In a series of surprise inspections, just 4 out of 37 compounding pharmacies passed.  The Governor proposed an additional $1 million for pharmacy inspections next year.

So it comes as a surprise that the Governor’s requested budget was cut to zero by the Massachusetts Senate Ways & Means FY 2014 proposed budget (4510-0772).  Sen. Keenan has filed an amendment to restore about $600,000 for additional compounding pharmacy inspections (proposed amendment 513), but it is not clear whether that amendment will pass or whether that amount is sufficient. Action by the US Congress may take some time, so it is up to the states to police compounding pharmacies until we get federal legislation.

Prior TIE posts here.  I was an appointed member of the special commission.


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