Most of us probably assume that the medications we get by prescription are safe because the drug manufacturers that mass-produce them are regulated by the U.S. Food and Drug Administration (although recent scandals in which agency whistle-blowers warned about the danger of medical devices may shake that faith.)
But tainted injections that apparently caused the meningitis outbreak are not regulated by the FDA in the same way as typical prescription drugs. They are compounds that supposedly are individually mixed to fill special prescriptions for specific patients - for example, with reduced dosages or without ingredients that may cause allergic reactions. These medications aren't supposed to be made in bulk or without individual prescriptions.
These so-called "compounding pharmacies" are regulated by the states and so, by definition, the rules differ from location to location. In reality, many companies like NECC - which sent out 17,000 doses of this particular steroid medication, at least some without individual prescriptions - have crossed over into pharmaceutical manufacturing while avoiding the federal regulation that is supposed to go with it. Over the past decade and a half, attempts by the FDA to regulate such companies have been thwarted first in the courts and then by a massive lobbying effort in Congress.
The process has become all too predictable: In 2007, the late U.S. Sen. Ted Kennedy and two Republican co-sponsors pushed for tighter regulations in Senate legislation, which was blocked when the industry opposed it aggressively. Attempts by the FDA to regulate the pharmacies often have meant taking on an army of industry lawyers.
Then-FDA Commissioner David Kessler was on target in 1996 when he warned that, without oversight, these pharmacies could spawn a "shadow industry" of unapproved drugs.
Now, as thousands of people who got the tainted injections worry about becoming sick, U.S. Rep. Edward Markey, D-Mass., says he will introduce new legislation to require consumer protections from the industry: complying with basic minimum safety standards, banning ingredients that aren't FDA-approved, submitting to thorough inspections and warning patients of compounded pharmaceuticals.
Members of Congress who care about health and safety should support it. It's time to finally learn the moral of this story.
