MA Tries To Get Tougher on Compounders
January 8th, 2013 // 5:05 pm @ jmpickett
In the wake of the fungal meningitis scandal that regulators have traced to the New England Compounding Center, Massachusetts Governor Deval Patrick late last week proposed new laws in hopes of preventing another debacle. So far, the outbreak has led to 656 cases and 39 deaths in 19 states (see this and this).
The move comes amid an embarrassing episode for both state health authorities and the FDA, which have offered confusing explanations about their failure to follow up early indications that the compounder had committed various infractions. The ensuing ruckus has led to congressional probes in the proper role regulators are expected to play.
The new Massachusetts legislation would create strict licensing requirements for compounding sterile drugs; allow the state to assess fines against pharmacies; establish whistleblower protections for compounding pharmacy employees, and reorganize the state pharmacy board to include more members who are independent of compounders.
The new regulations also require all licensed pharmacies and pharmacists to report to the pharmacy board when they are the subject of any disciplinary action by any state or federal agency. The hopes is that the state pharmacy board would be alerted to issues with Massachusetts pharmacies that do business in other states.
“There is no action that we in government can take to prevent all abuses in the industry. But we must do what we can and continue to work with our federal partners to fill the regulatory gaps that we have identified,†Patrick said in a statement. “Together these changes can ensure that the significant harms we have seen from substandard compounding are never allowed to happen again.â€
State officials have been scrambling to cope with the compounding problem since it surfaced last September, especially since Sophia Pasedis, who sat on the 11-member Massachusetts Board of Registration in Pharmacy, was listed as vp of regulatory affairs and compliance at Ameridose, which is owned by the same people – Barry Cadden and Gregory Conigliaro – who own the New England Compounding Center.
Since then, Patrick ordered more surprise inspections at compounding pharmacies (read here) and fired its state pharmacy board chair and placed the board attorney on leave for allegedly ignoring a complaint last July that bulk shipments of drugs were distributed to hospitals in Colorado (see this).
Whether the moves by Massachusetts will be sufficient remains, of course, to be seen. This is just one state in a patchwork of state regulations, which suggests this sort of problem may still arise elsewhere. New England Compounding Center, for instance, was not required to obtain a license for large-scale compounding or to inform state regulators that shipments were being made beyond Massachusetts.
By requiring out-of-state compounders to obtain licenses before they can ship to Massachusetts, state officials are trying to plug a hole. “Basically, if you think about the large hospitals, the amount of medical care that goes on in the state, it’s in a sense using the purchasing power of the state of Massachusetts to induce changes elsewhere,†Daniel Carpenter, an FDA historian at Harvard University, tells The New York Times.
As for the FDA, the agency has argued that court rulings prevent it from pursuing compounders unless they engage in large-scale manufacturing. The FDA has been criticized for failing to pursue enforcement action against the New England Compounding Center, though, after issuing a 2006 warning letter and the compounder had regularly shipped large volumes of compounded medicines around the country.
The FDA, however, had previously declared a willingness to pursue compounders that engage in the equivalent of drug manufacturing. Recently, FDA commish Margaret Hamburg proposed creating two classes of compounders that would purportedly make it easier to determine when certain violations should be pursued by state and federal regulators, respectively (read more here).
