The Commerce Clause and Fungal Meningitis
The ongoing tragedy of death and severe illness from fungal meningitis dramatically illustrates the danger of Neocons’ narrow view of the Commerce Clause of the U.S. Constitution. It’s a perfect example of why a broader, not narrower, interpretation of the Commerce Clause is critically important.
A “compounding pharmacy” in Framingham, Massachusetts has been identified as the source of fungus-contaminated steroid solution. The steroid solution is intended to be and has been injected into patients’ spinal columns. When contaminated by fungal spores, fungal infections can lead to life-threatening infections in the spinal cord canal and brain. At least eleven persons have died.
Compounding pharmacies, like New England Compounding Center, the suspected source of the contaminated vials of steroid solution, are unregulated by the federal government. The absence of regulation results from a poorly drafted federal law and the U.S. Supreme Court’s blinkered interpretation of the that statute. In 2002 in Thompson v. Western State Medical Center, the U.S. Supreme Court found that the Congressional restrictions on commercial speech – advertising – by compounding pharmacies was unconstitutional, and through out not just the speech limitations but the entire body of federal law regulating “compounding pharmacies,” outfits that assemble known drugs. So regulation is left to the state level and is woefully ineffective. Congress has not been able to get its act together to adopt new laws.
As a result, outfits like New England Compounding Center manufacture drugs, ship them into interstate commerce, and are almost completely unregulated. The butcher’s bill for the fungal-contaminated steroid vials so far:
The toll will undoubtedly get worse. Fungal meningitis can take as long as 30 days for cause symptoms, and is notoriously difficult to treat.
In the absence of federal regulation, and in the face of individual state’s inadequate resources to regulate, there is no effective oversight. Instead, there’s the post hoc remedy of product liability regulation. New England Compounding Company is itself effectively dead. All of its products since the start of the year have been recalled. Plaintiffs’ lawyers are lining up and the usual Chapter 11 bankruptcy will probably ensue. It’s the moral equivalent of leaving the hung corpse hanging from the tree to rot, as a warning to others. But there’s no evidence that the hanging corpses deterred criminals and there’s no evidence other unregulated compounding pharmacies would – gasp – reduce profits by imposing FDA-standard self-inspection. Anyone who thinks self-regulation works is invited to read Upton Sinclair’s The Jungle as remedial homework.
Nor is there any way that a state like Tennessee – the state with most case counts and deaths so far – can police drugs entering that state.
In any sensible view of the world, outfits like New England Compounding Center, which “compounds” some 2,400 different drugs and distributes them in at least 13 different states, is a drug manufacturer, and not you neighborhood pharmacy assembling a special version of a drug for you because you have an allergy to the standard filler. But after the regulatory cloud from Western State Medical and Congress’s inaction, everyone pretends it isn’t in the business of manufacturing drugs and therefore is unregulated by the FDA.
Which takes us to the Neocons and their narrow view of the Commerce Clause in the U.S. Constitution. An originalist like Justice Antonin Scalia (yes, he was in the majority in Western State Medical) would argue that because the Constitution is silent on interstate shipment of compounded drugs, the federal government has no jurisdiction. Paul Ryan would take us back to the narrow, long-rejected view of the 1930′s. His idol, Ayn Rand, would reject any government oversight of the manufacture of medicines. But two conclusions can be drawn from Food & Drug Administration regulation of medicines.
First, it works pretty well. Yes, the FDA has let some bad stuff slip through, but overall things are much better than the unrestricted, free market days when poisons, narcotics and patent nostrums could be sold without regulation. The FDA is the best means we’ve found so far to the problem of protecting the public from the toxic combination of rampant capitalism and bad medicine.
Second, and more importantly, no one has a better solution that works as well, let alone better. Free market nut jobs who would allow the industry to regulate itself have forgotten, or are ignoring, or are utterly ignorant of history. We tried it. It didn’t work.
All of which is why a broad interpretation of the Commerce Clause, allowing the federal government to regulate companies like New England Compounding Company, is critically important. Lives depend on it. Indeed, WC would argue lives have been needlessly and senselessly lost because Congress has failed to act.