"Pre-emption" is a legal doctrine that says the federal government can claim all regulatory power over an area or subject, barring states from acting on their own. The drug maker Wyeth has brought a case before the Supreme Court arguing that a woman in Vermont, who lost her arm due to a drug complication that Wyeth knew about but did not publicize, cannot sue them in state court because of pre-emption. Wyeth says that only the FDA has the power to regulate it—and since the FDA approved Wyeth's drug label, it's the FDA's responsibility. We think Wyeth is pretending to care about federal-versus-state power in an attempt to weasel out of any responsibility.
We understand why Wyeth would pursue this line of reasoning—after all, if they win, then it will put an end to personal lawsuits against drug companies. But if Wyeth got its way, the result would require a huge expansion in the FDA's role in bringing drugs to market and monitoring them afterward, because the FDA would have to shoulder the burden of responsible drug testing and labeling. If the FDA took over this responsibility, it would have to balloon to an enormous and almost certainly unwieldy government agency, and it would likely slow down the time it takes to bring new drugs to market.
On the other hand, it's quite possible that the FDA would simply hobble along in an underfunded, understaffed state, paralyzed by bureaucratic jams and strangled by politicians and the lobbyists who feed them.
This is why we think Wyeth is being duplicitous, by arguing for one thing—greater federal regulation—while knowing that in reality, having only the FDA to answer to will mean less risk of being held responsible for mistakes, incomplete research, or inappropriate marketing.
We're sure Wyeth would love to have it both ways, with limited regulatory oversight combined with the protection of a federal agency that's largely toothless. We hope the Supreme Court tells Wyeth to pay the Vermont woman her $7 million—and to label its drugs more clearly if it wants to avoid such payouts in the future.
"Consumer Issues Top Supreme Court's Docket" [NPR]
"Plainfield Pianist's Case Could Affect Nation" [WCAX] (Thanks to Michael Belisle!)
(Photo: Getty)