Last year an outbreak of meningitis killed 53 peoplein 20 states and sickened more than 720 nationwide. As many as 14,000 patients may have been exposed to the deadly drug.
This was not a natural disaster but a human-made and preventable tragedy. It was caused by a tainted steroid distributed by the New England Compounding Center (NECC), which is part of an obscure $2 billion-a-year niche of the pharmaceutical industry called "compounding pharmacies." At doctors ' request, these firms make customized medications for individual patients, but some have morphed into large manufacturers outside the federal Food and Drug Administration's regulatory reach. Instead, compounding pharmacies are overseen by a state agencies that have a crazy-quilt of different standards, resources, and expertise.
Now some members of Congress are trying to reign in this shadow drug industry by giving the FDA the authority to regulate these firms. But the industry is fighting back, using its political clout to resist federal standards. Like most industries in this situation, they claim that stronger government oversight will hamper their ability to operate profitably. And, like those other industries, the compounding pharmacies are crying wolf.
Under pressure from Cong. Ed Markey (D-MA), the House Energy and Commerce subcommittee is holding hearings Tuesday to bring this issue to public attention. Last week he issued a reportdocumenting that state authorities charged with overseeing compounding pharmacies lack the most basic information about the companies they are supposed to regulate. According to Markey's report, state boards of pharmacy often don't know which pharmacies in their state engage in compounding, how much medication they make, how much of it is sterile or whether any products are sold across state lines. Only Mississippi and Missouri routinely keep track of the number of compounding pharmacies in their states.
State boards don't consistently inform each other, or the FDA, when problem emerge with pharmacies producing dangerous products. Concerned about this lack of transparency, the Iowa pharmacy board is now inspecting over 600 out-of-state pharmacies that ship medications into Iowa. The inspections have already led Iowa to issue charges against five compounding pharmacies, including failure to comply with regulations that require compounders to have prescriptions for specific patients. But no other states have followed Iowa's example.
"In states from coast to coast, compounding pharmacies are going untracked, unregulated and under-inspected, exposing patients everywhere to tainted drugs, disease and death," Markey said in a statement.
"In states from coast to coast, compounding pharmacies are going untracked, unregulated and under-inspected, exposing patients everywhere to tainted drugs, disease and death," Markey said in a statement.
continue to read here