Big Pharma, Little Compounding Pharmacy. It's Not That Simple.

I know that I've been following the ongoing story of a fungal meningitis outbreak closely because it could so easily have been me.

For those of you who haven't: To date (according to today's New York Times story by Denise Grady), eight people have died, 97 others have sickened, and as many as 13,000 may have been exposed to fungal meningitis, which has been traced to a tainted steriod given as a spinal injection for relief from back and neck pain. The medication in all cases was made by Massachusetts-based New England Compounding Center, which "has shut down, surrendered its license and recalled all its products, not just the steroid."

It is not yet known whether all the vials of the steriod were infected with fungus, or only some of them.

I had surgery several years ago to relieve back pain, and I'm among the lucky who have not (knock wood) had recurring problems. But one of the physicians I met before opting for surgery suggested that quarterly steriod injections could probably do the trick just as well. I was concerned about possible long-term effects of steroid use, hence the surgery. But, as I said, it could have been me.

How is it that so many people were exposed to this contaminated drug? How could it take so long to find out what happened? Why is it still not clear where all the drug went, and who received it? (The "13,000" figure I quote above is a "first estimate" from the Centers for Disease Control and Prevention.)

It turns out that

The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts

according to a Boston University law professor, quoted in Saturday's Times, in an article by Denise Grady, Andrew Pollack, and Sabrina Tavernise. (Compounding pharmacies, the article explains, "mix up batches of drugs on their own, often for much lower prices than major manufacturers charge," and are increasingly used by some physicians and clinics to save money. Compounding pharmacies also sometimes fill "gaps left by shortages of drugs made by pharmaceutical companies.")

The problem is that 

Compounding falls in a legal no man’s land, between the federal government and the states. The F.D.A. regulates manufacturers, but compounders register as pharmacies, putting them under a patchwork of state rules. The F.D.A. did develop a clear set of rules for compounding, but subsequent litigation that culminated in a Supreme Court decision in 2002 struck them down, and Congress never re-established the agency’s clear authority...

Who knew? Well, somebody did, of course, but it was certainly news to me. And I might have been more trusting of a "compounding pharmacy" -- because that sounds more local and service-oriented -- than of a huge pharmaceutical company.

Not that all compounding pharmacies are that local (or, obviously, that service-oriented). New England Compounding was apparently licensed in all fifty states, and there are 23 states now tracking where this specific steroid went. A Washington lawyer, and a former chief counsel for the FDA, was quoted in Saturday's article as saying,

Some of these companies are just setting up big manufacturing shops in the guise of traditional compounding and making drugs that are, for the most part, commercially available. Instead of making fake Rolexes, they are making fake drugs.

If this is how industries self-regulate (and all too often, it is), is it any wonder that I keep asking for more regulation, not less?