Federal Pre-Emption: A Regulatory Prescription

By June 20, 2007Health Care

NAM President John Engler has an op-ed in today’s Detroit News expanding on the issue we touched on yesterday: the need to maintain federal pre-emption, i.e., FDA pre-eminence, in the regulation of medical devices and pharmaceuticals. Regulation by 50 states and the resulting storm of litigation would squelch medical R&D and harm people’s health. Engler:

Initially, cleverly hidden in a package to fund the FDA was an obscure provision giving a green light for courts to determine what standards of safety and effectiveness would apply to medical devices or pharmaceutical drugs, regardless of the judgment of the FDA’s expert physicians and scientists. It has been removed, but there’s a strong lobbying effort to restore it.

The issue is “federal pre-emption.” In 1976, Congress gave the FDA exclusive authority to regulate medical devices — things like surgical instruments, stents and X-ray machines. Lawmakers understood that for scientific innovation to thrive, consistent and predictable rules overseen by a single authority were necessary. For pharmaceuticals, pre-emption authority is less explicit, but courts usually defer to the agency’s expertise.

One suspects that these provisions are a political payoff to the plaintiff’s bar. It’s a strong suspicion.

Fortunately, the language was stripped out of drafts yesterday, but the lawsuit-happy trial attorneys and their congressional confreres are adept at sneaking through legislative language. So stand guard.

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