Federal authorities acknowledged today that some larger-scale custom drug providers may initially escape detection under a new law intended as a response to a meningitis outbreak that sickened hundreds across the U.S. and led to 19 deaths in Michigan.
Officials with the U.S. Food and Drug Administration generally praised the new law today, saying it gives them more tools with which to regulate larger operators that sign up as outsourcers while leaving smaller, more traditional pharmacies that custom-mix drugs mostly to the states.
But Jane Axelrad, associate policy director for the FDA’s Center for Drug Evaluation and Research, noted it is up to larger-scale compounding pharmacies to register voluntarily as outsourcers, for which they will qualify for certain FDA exemptions and in turn submit to federal oversight and inspection.
“It will be difficult for us to identify compounding pharmacies that choose not to register as outsourcers and try to hide out in the category as traditional compounders,” she said.
In those cases, she added, the government would continue to work with states to find problem operators and take action, but would be limited in making any “proactive inspections.”
The law, passed with bipartisan support in Congress and signed last week by President Barack Obama, has been largely welcomed as a step forward in updating pharmacy rules. But it has still left some victims of the outbreak complaining that little has been done to rein in an industry they consider too unregulated.
“All they did was put something up there that is window dressing. They didn’t do anything,” said 58-year-old Mark Klaserner of Milford, who got fungal meningitis after a spinal injection in September 2012 and still suffers from chronic back pain that makes it difficult to walk, work or sleep more than two hours at a stretch.
FDA Commissioner Margaret Hamburg said the agency plans to keep up its efforts to inspect and, where necessary, take action against compounding pharmacies that have become de facto drug manufacturers. Those efforts have become more aggressive since last year’s outbreak.
Traditionally, compounding pharmacies custom make pharmaceuticals based on individual needs and prescriptions. But in recent years, larger-scale operations — which would fall into the category of outsourcers — have provided bulk orders of custom-made pharmaceuticals to hospitals and other health care providers.
Last year’s meningitis outbreak was linked to tainted steroid injections distributed across the country by the New England Compounding Center (NECC) in Massachusetts. More than 750 cases — including 64 deaths — were reported in 20 states. Michigan, with 264 cases and 19 deaths, was the hardest hit.
Reports indicated problems at the NECC had been detected before the outbreak, and congressional investigators questioned why the FDA didn’t intervene earlier. But the law about who had authority — the state or the FDA —was considered murky. The new legislation, sponsored by U.S. Rep. Fred Upton, R-St. Joseph, helps clear that up.
Meanwhile, by creating the new class of outsourcers that submit to inspections and come under federal authority, it’s hoped that hospitals and other large health care providers will more readily turn to those firms, with the outbreak stoking worries. That, in turn, will put market pressure on pharmacies to register voluntarily.
But it still leaves traditional compounding pharmacies largely under the authority of state pharmacy boards.
Hamburg said while the new law didn’t give her agency all the authority she had hoped for, it was “definitely progress.” And given the concerns about the outbreak last year, hospitals and health care providers will be eager to purchase from FDA-approved outsourcers, she said.
“This will be a great relief to many health care providers and their patients,” she said.