Clinical Trials

Beating the FDA in Court

Alexander Volokh from the May 1995 issue

They say that whenever someone sued the FDA in the early '70s, Peter Barton Hutt, the FDA's chief counsel, would go into court and say, "The Food and Drug Administration is the expert scientific agency charged by the U.S. Congress and the president to protect the safety of pregnant women and small children." At that point, the case was effectively closed.

This story isn't true, but it might as well be. The FDA has been called "the agency that never loses." It almost never gets challenged, and when it does, it almost always wins. It's big. It's usually challenged on questions of fact and not on questions of law, which makes judges defer to it most of the time. It uses complicated words from science. It has the taxpayers paying its legal tab. It's going to be around for the rest of your company's life. And it never forgets.

There are two struggles going on for the soul of the FDA. The first is the debate over what the law should require the FDA to do, a debate that has intensified with Republican control of Congress. The FDA is consistently overconservative. It keeps life-saving drugs and medical devices out of the country and approves others only after interminable delays.

Tens of thousands of Americans die every year because they don't have access to the necessary medical technology. Consider the following estimates:

* Seven thousand people die every year because the FDA hasn't approved the Ambu CardioPump, a CPR device that is available in just about every other industrialized country.

* Nine hundred people die every year because the FDA hasn't approved the OmniCarbon heart valve, which also is in use just about everywhere else.

* From November 1988 to May 1992, about 3,500 kidney cancer patients died waiting for the FDA to approve the drug Interleukin-2, which was already available in France, Denmark, and seven other European countries.

* In 1988 alone, between 7,500 and 15,000 people died from gastric ulcers caused by aspirin and other nonsteroidal anti-inflammatory drugs, waiting for the FDA to approve misoprostol, which was already available in 43 countries.

* And 22,000 people died between 1985 and late 1987 waiting for streptokinase, the first drug that could be intravenously administered to reopen the blocked coronary arteries of heart-attack victims.

People may well come to the United States from other countries to take advantage of advanced surgical techniques and avoid waiting lists, but when it comes to things
under FDA jurisdiction, like drugs and devices, it's Americans who travel abroad. The FDA's caution and delays are also driving many companies to other countries. From 1992 to 1994, for example, Medtronic, a major medical-device manufacturer, moved 12 new businesses or new product lines to Europe, including its $40 million corporate ventures R&D group. And the Irish Bio Tech News reports that Ireland is now home to more than 40 expatriate American medical-device companies, employing 8,500 people, and that 10 more American companies are building facilities in Ireland.

Forty-five percent of device manufacturers say they want to move abroad. Newt Gingrich has called the FDA the "number one job killer in America." Joel Nobel, president of ECRI, an independent medical-device testing company, predicted two years ago that "it is unlikely that it will take Congress and [FDA's Device Center] more than another five years to destroy much of the U.S. medical device industry." Since the Republican takeover of Congress promises tougher scrutiny of the agency, Nobel no longer urges device manufacturers to emigrate immediately. But he remains wary.

Nobel explains how Congress sets FDA medical-device policy: "The theoretical American patient, beloved by Congress and consumer advocates, that they wish to protect from an avaricious industry and uncaring health-care community is a wonderful abstraction beloved, as well, by the media. But real patients hurt, bleed, and die for many specific reasons, which manufacturers and the health community address in detail. Those details are not understood by Congress and the FDA, and political ideology keeps consumer advocates from seeing technical issues in perspective.

"To Congress we must say that our road to hell is paved with your good intentions and that we understand your formula. First, require that the FDA do the unwise or impossible. A few years later, ask the General Accounting Office to tell you if the FDA is doing the unwise or impossible as instructed. Express shock and surprise when you learn that it is not. Hold hearings to pistol-whip the FDA and industry in order to support the passage of more unwise or impossible-to-implement legislation. Do not forget to include testimony from patients whose demonstrable suffering can be attributed to the FDA and industry derelictions. Be sure to use a few exceptional industry sins to justify collective guilt and punishment. Never allow testimony by knowledgeable witnesses who may disagree with your preordained conclusions and already-written legislation, unless they represent industry and can be portrayed as self-serving and mercenary."

FDA partisans have a one-word answer to such criticisms: thalidomide. In the early 1960s, thousands of European babies whose mothers had taken the sedative thalidomide were born with birth defects. FDA enthusiasts claim that it was only thanks to Dr. Frances Kelsey of the FDA and her stubborn questioning that thalidomide stayed out of the United States. But what this really means is that the FDA was already powerful enough to stop potentially dangerous drugs. Since the thalidomide scare, however, FDA has grown more powerful--and more deadly.

In 1962, Congress passed the Kefauver-Harris Amendments to the Food, Drug, and Cosmetics Act, which required that the FDA test all drugs for efficacy, as well as safety, before approving them. In 1976, because of problems with the Dalkon Shield IUD, Congress passed the Medical Device Amendments. These effectively extended the same requirements to medical devices--a broad category covering everything from pacemakers to Band-Aids. In 1990, because of defective heart valves and controversy over silicone-gel breast implants, Congress passed the Safe Medical Devices Act, which further restricted medical devices. More legislation followed in 1992.