Imagine the glee 10 years ago when owners of “compounding pharmacies” rebuffed moves to regulate their niche of the market. Congress had passed legislation to regulate compounding pharmacies in 1997, but the industry stalled Big Brother in court.
A decade ago the Supreme Court ruled for the industry. (See “Scant Oversight of Drug Maker in Fatal Meningitis Outbreak,” Denise Grady, Andrew Pollack and Sabrina Tavernise, New York Times, Oct. 6, 2012.) The Food and Drug Administration would do only “policy guidance.” You can hear the champagne corks popping as administrators toasted their good fortune. No bureaucrats overseeing them. No subsequent inefficiencies. No need for “compliance officers” to document that you are doing what you are supposed to do, when – after all – the professional standards of your industry dictate that you do that anyway.
Libertarians must have added their cheers. This was a victory for the truly free market, unfettered by an expensive unnecessary Big Brother. Drink up!
The victory, though, was Pyrrhic.
The winners – now losers – face lawsuits, as well as bankruptcy. The government scrutiny that they eschewed will, I hope, happen.
Worse, patients suffered. Some died.
The tale bears retelling – a lesson to free-market enthusiasts yearning to evict government from the economy.
Compounding pharmacies make, or repackage, a very few products. A hospital may need small syringes of anesthesia: the compounding pharmacy will dip into a vial to create syringes. They make pumps, with dosages tailored to the patient, to be implanted. A drug that will help an adult patient will not work with a child: if the manufacturer does not explicitly make a pediatric version, the compounding pharmacy will tailor the dose to the child. The pharmacy can combine different medications into one dose. These pharmacies fill a genuine need.
As for oversight, compounding pharmacies fall under their states’ umbrellas, overseen by state licensing boards – the boards that oversee the pharmacies at CVS, Walgreen’s, and local independent pharmacies. Those pharmacies, however, don’t “compound,” or make, drugs. The FDA strenuously regulates the pharmaceutical manufacturers which do make drugs.
But compounding pharmacies – which also make drugs — eluded the Big Hand of Big Brother. They argued that they customize drugs for patients. Surely that didn’t require federal oversight. Perhaps if they had limited themselves to custom-tailoring drugs for specific patients, this story would not have unraveled this way.
Unhappily, but maybe not surprisingly, compounding pharmacies started to mass-produce their products. There was a need for these drugs, which translated into a demand; the compounding pharmacies stepped into that market-gap. They expanded their reach. Given the strong demand for these drugs, some independent pharmacies carved out a side-business, as compounders.
The crisis-of-the-moment came when the New England Compounding Center of Framingham, Mass. (licensed in all states) shipped 13,000 doses of a contaminated steroid, for injection, to 23 states. To date, 170 people have contracted a fungal meningitis infection; 14 have died. Public health experts fear more cases.
The meningitis outbreak was not an aberration. For years the FDA, in its “policy guidance role,” and the Centers for Disease Control and Prevention, have monitored these pharmacies, tracing the outcomes of poor practices. In 2006 the FDA sampled drugs from compounding pharmacies: it found problems with one-third. Last March 33 patients in 7 states developed eye infections after surgery. The CDC traced the culprit: drugs from a Florida pharmacy. One year previously, 9 patients in 6 Alabama hospitals died from nutritional supplements made with contaminated water. That culprit: a pharmacy in Birmingham. A few years before, a compounding pharmacy in Texas did not measure doses of intravenous pain medication correctly: two patients, in Washington and Oregon, died. In the last decade, the FDA has issued 40 “warning letters.”
The meningitis outbreak, because of the sheer numbers, may spark Congress, even a right-leaning one, to rethink its “hands-off” policy.
Joan Retsinas is a sociologist who writes about health care in Providence, R.I. Email retsinas@verizon.net.
From The Progressive Populist, November 15, 2012
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