Few people heard of “compounding pharmacies” before a meningitis outbreak killed 64 people a year ago. The disease was traced to a tainted, injectable steroid medication shipped across the country from a mold and fungus infested facility outside Boston where it was mass produced without federal oversight.
Thanks to a gap in the law the New England Compounding Center’s operation was perfectly legal, even though it’s product proved lethal. Congress has now moved to fill that gap, but with a bill that will still allow some compounding pharmacies to make drugs without prescriptions and ship large batches across the country, all without federal oversight.
That’s because the optimistically labeled Drug Quality Security Act makes regulation by the Food and Drug Administration voluntary. The bill, which would also create a national system for tracking prescription drugs from manufacturers to retail pharmacies, was passed by the Senate Monday, the House last month and is now headed to the White House for the president’s signature.
“Compounding pharmacies” traditionally tailor make drugs for one patient at a time based on a prescription, for instance if a person is allergic to some ingredient or has some other special need. But the practice has changed dramatically over the years.
Some pharmacies now compound drugs on a mass scale, as the center responsible for the meningitis outbreak did before it closed its doors. They’ve become mini-manufacturers, but without the federal oversight required for other drug makers.
Under the bill, compounding pharmacies that ship drugs made without individual prescriptions could voluntarily register with the FDA as “outsourcing facilities” and submit to federal inspections and quality standards similar to those imposed on drug manufacturers. But they could also chose to stay with the status quo, which means an inadequate patchwork of state regulation and no FDA oversight.
In not mandating federal regulation Congress is betting that doctors and hospitals will prefer to buy from a facility with the FDA seal of approval. So Congress is counting on market forces to push the pharmacies to accept federal regulation.
It’s a dangerous gamble.
The meningitis tragedy wasn’t an isolated incident. Sen. Tom Harkin, chairman of the Senate Health, Education, Labor and Pensions committee, said “over the last decade patients have suffered a range of grievous — even fatal — infections as a result of compounded drugs that were contaminated or improperly formulated.”
Congress must keep a sharp eye on how this plays out. If market pressure works, that’s great. But if it doesn’t, Congress must mandate muscular oversight.