Massachusetts Governor Deval Patrick has unveiled legislation aiming to plug a regulatory gap that allows large compounding pharmacies to operate with little oversight.
The state's effort to crackdown on compounders, which traditionally alter drugs to meet specific patients' needs but have since expanded to produce medications in bulk, was sparked by a deadly outbreak of viral meningitis linked a now-shuttered pharmacy in Framingham, Massachusetts. The company distributed a tainted steroid suspected of sickening or killing as many as 620 people in 19 states.
The governor's bill, announced Friday (January 4), would likely make Massachusetts the nation's toughest regulator of compounders, requiring them to apply for special licenses, while authorizing the state Board of Pharmacy to levy fines against wayward companies and granting whistleblower protections to pharmacy workers who report violations. The legislation would also reorganize the board, adding experts from outside of the pharmacy industry, in an effort to reduce conflicts in interest.
“There is no action that we in government can take to prevent all abuses in all industries – but we must do what we can,” Patrick said. “Together these changes can ensure that the tragic events of last fall never happen again.”
The federal government regulates drug manufacturers, which make and sell drugs to wide markets. Oversight of compounders, meanwhile, has been left to states, which license pharmacists. But in the past decade, as Stateline has reported, compounders have moved beyond their original one-patient, one-prescription standard and begun to develop and sell their products in bulk.
Critics say states are ill-equipped to oversee the large compounders, particularly because pharmacy boards typically lack enforcement capabilities, leaving the companies to operate largely unregulated.
“State boards are not trained in public health and there's no evidence they are proactively overseeing these practices,” Sarah Sellers, a consultant on drug safety and former member of the Food and Drug Administration's Oversight Committee on Pharmacy Compounding, told Stateline.
That's currently the case in Massachusetts, which the governor says he wants to change. On top of the enforcement power his bill would grant, Patrick, a Democrat, says he will also order the Department of Public Health to boost its inspection staff, requiring that each inspector have at least five years of clinical experience. Inspectors working with compounders would receive additional training.
In the wake of the meningitis outbreak, Massachusetts had already required compounders to report volume and distribution of their drugs, which will alert state regulators of compounders acting more like manufacturers. The state had also launched a series of surprise inspections.
Patrick's legislation, based upon the recommendations of a state commission assembled in October, is expected to move quickly through the legislature. It carries the endorsement of U.S. Representative Ed Markey, a Massachusetts Democrat. The Congressman, however, has pushed federal solutions to fill the void left by states.
In October, Markey released a report that linked compounding pharmacies to at least 23 deaths and 86 serious illnesses in 34 states — even before the Massachusetts outbreak.
“Because compounding pharmacies do not limit their sales within the borders of any one state, patients in Massachusetts and throughout the country are still vulnerable to safety failures by pharmacies located in states with weaker laws,” Markey said in a statement. “This is a nationwide problem.”