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Should We Be Thankful for the FDA?


The television anchorman presented the news in an excited tone: “The Food and Drug today approved use of a new laser technology that will replace the drill at the dentist’s office.” According to the story, most patients tested with the new laser device needed no pain killer. The announcement must have been well-received by everyone, since most people hate the dentist’s drill.

But something bothered me about the story. From what the anchorman had to say, you’d think the FDA had done us a magnificent favor. After all, it was allowing us to have this pain-eliminating device. Shouldn’t we be grateful?

That was the implication of the story. But it’s not quite accurate. You’d have never known from that news coverage that some ingenious person outside the government invented the device. Private interests invested lots of money to finance its development, production, and testing. In other words, it was a product of the innovative free market.

Yet the FDA was getting the credit. What was the agency’s real role in this matter? Let’s see. Premier Laser Systems asked the FDA to approve the device on almost four years ago. It finally did soon May 9. For all the intervening time the FDA forbade use of a device that would have brought comfort to the lives of millions of people. Now that it is finally allowing the laser treatment to be used, it expects gratitude. They call that chutzpah.

Maybe delaying use of a tooth-decay treatment is not so serious. But the same thing happens with life-saving drugs and devices. Typically, when the FDA approves a cholesterol or blood-pressure treatment, it proclaims that because of its actions the lives of tens of thousands of people each year will be saved. The flip-side of that statement is that for the preceding several years, the FDA has been responsible for the deaths of that number of people.

But isn’t the FDA saving lives by carefully reviewing devices and drugs before they come to market? Economist Robert Higgs says no. In a Cato Institute report a few years ago, he pointed out that the FDA’s approval time for devices has lengthened to as much as two and a half years and the cost has grown, including the cost in lives. Being a bureaucracy, the FDA uses one inflexible standard and often responds to sensational headlines. At bottom is an impossible goal: perfection. For example, a heart defibrillator that worked more than 99.9 percent of the time was treated like a shoddy product. No medical device will be perfect, but the FDA’s quest for perfection severely raises costs — and kills people as well.

The defender of the FDA will usually play the thalidomide card. This was a 1960s tranquilizer, used in Europe, that turned out to cause serious birth defects when taken by pregnant women. It was banned in the United States. But the FDA itself has eroded the power of that argument. Not long ago it approved the use of a drug for extreme acne that also can cause birth defects. The FDA simply told doctors not to give it to pregnant women.

Consumers, of course, need protection from products that can do them harm. The question is how best to accomplish that. In a variation of Gresham’s law about money, it turns out that bad protection drives out good. Government provides bad protection. With the FDA, it is all or nothing; a product is either approved and allowed on the market or disapproved and banned. That violates the right of individuals to select the level of risk they are most comfortable with. That level, like nearly everything else, differs widely from person to person. In the case of AIDS drugs, it has dawned on people that perhaps someone with a terminal illness won’t mind a highly risky treatment. That principle should apply across the board. But bureaucrats will always be afraid of approving a drug that might hurt someone. So the tendency will be overcaution – deadly overcaution.

Market-based consumer protection is preferable because it is flexible and responsive to the varying consumer needs. Firms tend not to want to kill their customers, and independent testing services will be happy to evaluate products, just as Consumer Reports and Underwriters Laboratories do. There would be no shortage of information if the government would get out of the way.

But as long as the FDA exists, it will stifle the market for consumer information in medical drugs and devices. If we want good, market-based protection, we have to get rid of bad, government-based “protection.” There’s no time to lose.

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Sheldon Richman is former vice president and editor at The Future of Freedom Foundation and editor of FFF's monthly journal, Future of Freedom. For 15 years he was editor of The Freeman, published by the Foundation for Economic Education in Irvington, New York. He is the author of FFF's award-winning book Separating School & State: How to Liberate America's Families; Your Money or Your Life: Why We Must Abolish the Income Tax; and Tethered Citizens: Time to Repeal the Welfare State. Calling for the abolition, not the reform, of public schooling. Separating School & State has become a landmark book in both libertarian and educational circles. In his column in the Financial Times, Michael Prowse wrote: "I recommend a subversive tract, Separating School & State by Sheldon Richman of the Cato Institute, a Washington think tank... . I also think that Mr. Richman is right to fear that state education undermines personal responsibility..." Sheldon's articles on economic policy, education, civil liberties, American history, foreign policy, and the Middle East have appeared in the Washington Post, Wall Street Journal, American Scholar, Chicago Tribune, USA Today, Washington Times, The American Conservative, Insight, Cato Policy Report, Journal of Economic Development, The Freeman, The World & I, Reason, Washington Report on Middle East Affairs, Middle East Policy, Liberty magazine, and other publications. He is a contributor to the The Concise Encyclopedia of Economics. A former newspaper reporter and senior editor at the Cato Institute and the Institute for Humane Studies, Sheldon is a graduate of Temple University in Philadelphia. He blogs at Free Association. Send him e-mail.