Drug regulators’ ‘pre-emption doctrine’ worth preserving?

Tevi Troy devotes a Wall Street Journal column to a U.S. Supreme Court case involving something known as the “pre-emption doctrine” in connection with the Federal Food and Drug Administration.

The pre-emption doctrine, urged by the FDA during the Bush administration, was established to protect the agency’s ability and authority to regulate the safety and effectiveness of drugs nationwide. The left detested pre-emption, since it impeded the ability of trial lawyers to bring big dollar lawsuits in state courts challenging FDA regulatory decisions.

The American Association for Justice—the trial lawyers lobby—claims that “pre-emption of state law means complete immunity from lawsuits for corporations and a full escape from accountability when they have knowingly injured and endangered Americans.” It means nothing of the sort. Pre-emption means that if a federal agency is to regulate drugs, it must be able to set nationwide standards. Otherwise, we will be subject to a crazy-quilt world of different legal regimes in each state that would make the production of lifesaving medications difficult or impossible. …

… For all of its imperfections, the FDA is the nation’s pre-eminent drug regulatory body, and its ability to approve products goes to the heart of our health-care system. If the Supreme Court rules that nonexpert juries can second-guess the decisions of FDA scientists, then manufacturers would rightfully be reluctant to produce lifesaving, life-extending medications, which provide the U.S. and the world with enormous health-care and economic benefits. No wonder the Obama administration has recognized that this case is a bridge too far.

Of course, one need not be a left-of-center political partisan to question the FDA’s role in regulating drugs. Libertarian John Stossel has argued persuasively that the FDA generally does more harm than good.

Kokai: So what do libertarians need to do to reach people and convince them that, say, regulation of something like the pharmaceutical industry does more harm than good?

Stossel: By and large, we don’t get to them. We don’t convince enough people. But you have to answer it one by one. If they say the pharmaceutical industry, I would say it does intuitively sound right. I don’t want some snake-oil seller to sell me something that might hurt me. They’re all looking to make money. They’re all greedy. And it’s nice that the [Food and Drug Administration] is there to make sure it’s safe and effective.

But think about it. A few years back they said, “Oh, we’re going to approve this new heart drug, and it’ll save 14,000 American lives a year.” And all the reporters said, “Great.” But it takes 10 years and $1 billion to get a drug approved. So if they’re saving 14,000 this year with the new drug, didn’t that mean they killed 14,000 people last year and the year before that — back 10 years? It did mean that. But you don’t think that way. You only think about how you’re being protected. You don’t think about all the life-saving stuff we don’t get because this process is so burdensome.

Furthermore, are we free, or are we not? Don’t you own your own body? If you’re dying of a terminal illness, you’re not allowed to experiment with a drug in America. You have to break your country’s laws and sneak to some other country. Isn’t that anti-freedom? Each of these arguments takes a while — takes some work.