January 25, 2013
A former FDA regulator turned compounding pharmacy watchdog told state lawmakers the loosely regulated industry has gone unchecked for too long and warned the deadly nationwide fungal meningitis outbreak linked to Framingham-based New England Compounding Center just scrapes the surface of problems linked to the industry.
“This is one we know about,” Dr. Sarah Sellers told the Herald after her hourlong testimony on Beacon Hill yesterday. “What we don’t know about is even more concerning because most drug-related problems are very difficult to detect, so we’re only getting the tip of the iceberg.”
Sellers alleged the industry operates with huge profit margins but under far less regulation than big pharmaceutical companies.
But the industry fired back, saying regulators need to enforce rules already on the books and that major incidents at compounding pharmacies are rare.
“There is no indication that this is an industry that’s out of control,” said Todd Brown of the Massachusetts Independent Pharmacists Association. “This whole thing would have been prevented if the FDA had done their job, enforced their regulations and if the Board of Pharmacy had enforced their regulations.”
A top state health official told the Herald things are changing post-NECC.
“This tragedy has been a wake-up call to all different sectors of that industry and the regulatory arena as well,” said Madeleine Biondolillo of the Bureau of Health Care Safety and Quality. “We’re very confident that between the work we’ve done to inspect the industry and get a lot more information than was ever provided before, we’re going to be increasingly effective.”
State Sen. Mark Montigny (D-New Bedford), who accused the industry of exploiting a lack of regulation it helped create through intense lobbying, said he thinks the aftermath of NECC will make it easier for lawmakers to tighten the rules.
“They’ve already lost the opportunity for constructive feedback,” Montigny said.
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