The governor of Massachusetts, Deval Patrick, has proposed new laws in a bid to strengthen the manner in which the state regulates the compounding of certain drug products.
The development comes after hundreds of people were made ill and dozens more killed by pharmaceutical products compounded at a Framingham, MA-based company. That company, the New England Compounding Center (NECC), was found by regulators to have been manufacturing products contaminated with fungal meningitis and consequently shut down.
At present, compounded products are regulated through a largely state-administered patchwork of regulations in which FDA has limited authority. The bulk of compounders are instead overseen by state pharmaceutical licensing authorities, whose ability to regulate depends on their particular state's laws.
Patrick's proposed law wouldn't do anything to change that paradigm, but does seek to heavily strengthen the authority given to state regulators.
The bill takes a four-part approach toward cracking down on compounding, requiring special licensing for compounders of sterile products, authorizing fines to be assessed against violations of compounding laws, requiring all compounded products in the state to have been manufactured at facilities licensed by the state of Massachusetts, and re-establishing the state's Board of Pharmacy with new controls.
"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 in a press statement. "This legislation makes patient safety paramount and will help fill the gaps in compounding pharmacy monitoring that allowed NECC to operate in the shadows."
"These changes can ensure that the tragic events of last fall never happen again," Patrick added.
Still, the legislation-if passed, as some expect-could face a number of difficulties. For one, compounders of sterile drugs could end up moving out of the state entirely rather than comply with regulations, raising the possibility of exacerbated drug shortages or simply that the worst offenders will wind up harming patients in other states.
The legislation could also end up being affected by bills slowly winding their way through Congress, which took a keen interest in the compounding scandal. One such act, the VALIDCompounding Act, sponsored by Ed Markey (D-MA), would preserve the authority of states, but other frameworks, including one proposed by FDA, would ban the sterile compounding now regulated by the states.
However, the state's massive healthcare market may make it too tempting of a target for most compounders to uproot themselves and flee. The success of Patrick's legislation in Massachusetts could well become a model for other states seeking to confront the same crises.