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Scientific Editor, BioPharm International
House Democrats have requested the Government Accountability Office (GAO) to conduct an inquiry into factors leading to an increased reliance on compounded products.
In the wake of congressional hearings into the events leading up to an outbreak of fungal meningitis caused by contaminated compounded medicines, House Democrats have requested the Government Accountability Office (GAO) to conduct an inquiry into factors leading to an increased reliance on compounded products.
Specifically, the legislators have asked for an investigation into Group Purchasing Organizations (GPOs), entities that negotiate drug and device prices for large operations, such as hospitals. In a letter sent to the head of the GAO, the legislators ask whether anticompetitive, exclusionary contracts between GPOs and generic drug manufacturers coupled with high fees have created a disincentive for manufacturers to produce some of the generic sterile injectables that are currently in shortage, causing hospitals and clinics to obtain them instead from compounding pharmacies. The letter points out that the drug at the root of the meningitis outbreak, methylprednisolone acetate, is currently in shortage.
Specifically, the letter’s authors ask the GAO to investigate:
In an accompanying press release, Rep. DeGette (D-CO) said, “In the drug shortage crisis of recent years, doctors and hospitals were increasingly forced to turn to compounding pharmacies like the one that caused the devastating meningitis outbreak. While we've begun to address drug shortages legislatively, it is clear we must aggressively investigate the factors that led to this deadly outbreak and determine possible remedies, so we can take steps to save patients lives.”